dental compounding - patterson park pharmacy · dental compounding we customize ... transdermal gel...

Dental CompoundingWe customize medications to enhance dental care.

2245 Eastern Ave. • Baltimore, MD 21231

Phone 410.675.6046Toll Free 855.859.2517

Fax 410.563.1147

[email protected]

©Storey Marke ng, All rights reserved.

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Compounding—an Introduc on ............................................................................................................. 2

Suppressing the Gag Reflex ..................................................................................................................... 3

Topical Anesthe cs .................................................................................................................................. 4

“Miracle Mouthwashes” ......................................................................................................................... 5

Protec on from/Therapy for Radia on or Chemotherapy‐Induced Oral Mucosi s ............................. 6

Tranexamic Acid for Preven on of Post‐Surgical Bleeding .................................................................. 8

Treatment of Oral Candidiasis/Resistant Fungal Infec ons ................................................................... 9

Aphthous Ulcers/Canker Sores ............................................................................................................... 9

Gingivi s/Gingival Hyperplasia/Periodontal Therapy ........................................................................... 11

Angular Cheili s/Stoma s/Lip Lesions ................................................................................................. 12

Alveolar Ostei s (Dry Socket) .................................................................................................................. 12

Therapy for Xerostomia ........................................................................................................................... 13

Topical Xylitol May Help to Prevent Caries ............................................................................................. 14

Tooth Avulsion and Preserva on ........................................................................................................... 14

3 Mix MP Provides Alterna ve to Extrac on ........................................................................................ 15

Orofacial Neuropathic Pain .................................................................................................................... 16

Temporo‐Mandibular Joint (TMJ) Disorder ............................................................................................ 18

Oral Implica ons of Menopause ............................................................................................................. 19

Burning Mouth Syndrome ....................................................................................................................... 20

Table of Contents

2245 Eastern Ave. • Bal more, MD 21231

Phone 410.675.6046

Toll Free 855.859.2517

Fax 410.563.1147

www.pa ersonparkpharmacy.com contact@pa ersonparkpharmacy.com

results.compounded

2 ©Storey Marke ng, All rights reserved.

Compounding combines an ageless art with the latest knowledge and state‐of‐the‐art technology, allowing specially trained professionals to prepare customized medica ons to meet each prac oner’s and pa ent’s specific needs. The demand for professional compounding has increased as healthcare professionals and pa ents realize that commercially available medica ons do not meet the needs of many pa ents, and that these pa ents may have a be er response to a customized dosage form that is “just what the den st ordered”. Our compounding laboratory contains specialized equipment such as an electronic balance, capsule machine, electronic mortar and pestle, and ointment mill. These state‐of‐the‐art devices are not found in most pharmacies, but they enable us to compound medica ons to each prescriber’s exact specifica ons. For example, an ointment mill reduces par cle size and therefore can be used to compound prepara ons containing higher concentra ons of ac ve ingredients than can be formulated using tradi onal methods. Ointment mills are ideal for compounding transdermal and topical medica ons, and provide a homogenized appealing mixture.

We prepare customized medica ons to solve problems for den sts and their pa ents. Change in Dosage Form ‐ If a pa ent is unable to take, has not responded to, or experienced adverse effects from commercially available medica ons, numerous op ons exist. We can compound the needed drug(s) into different dosage forms, such as cosme cally appealing creams, ointments, transdermal gels, topical sprays and powders, or lozenges. We can place the needed medica on into the best dosage form or base which is most suitable to treat a specific problem. For example, a lollipop can be just perfect for keeping an an bio c or an fungal in contact with an infected area in the mouth.

Transdermal formula ons may offer significant advantages to oral and injectable dosage forms. When a pa ent has difficulty swallowing or if a medica on is only commercially available as an injectable prepara on, we can formulate the needed drug as a transdermal gel or cream that will facilitate drug absorp on through the skin. When an ill child or adult is res ng comfortably, but it’s me for the next dose of medica on ‐ the caregiver can administer a transdermal medica on without waking the pa ent. Transdermal medica ons are o en preferred by pets and their owners, as well. Troches, lozenges, freezer pops, chewable “gummy treats”, and lollipops are pa ent‐friendly dosage forms. Troches are lozenges that can be absorbed through the buccal mucosa. Flavored chewable “gummy treats” and lollipops can be compounded to contain numerous medica ons, and can be dispensed in child‐resistant containers. These are ideal dosage forms for children or pa ents who have difficulty swallowing, or when a medica on (such as an an ‐fungal drug) needs to be held in contact with the oral mucosa. Lip balms, applicator s cks, metered nasal or sublingual sprays, non‐aerosol topical sprays, creams and ointments can be used to apply medica on directly to the affected site. Insufflators are ideal for applying medica ons in powder form to hard‐to‐reach areas. Topical administra on can reduce the amount of drug that the pa ent absorbs systemically, and therefore may reduce the risk of side effects. We can compound cosme cally appealing creams, ointments, and gels containing the specific medica ons needed to treat each unique problem.

Individualized Dosing ‐ We can compound a dosage form that contains the op mal dose of drug (based on age, weight, and disease state) that is needed to treat the problem, but which minimizes the risk of adverse effects. Also, single doses of medica on can be prepared for school or travel. Change in Route of Administra on ‐ Some drugs are commercially available only as injec ons or oral dosage forms that must be swallowed. A pa ent may be unable to take medica ons orally or may not be permi ed to consume liquids or food required to administer the medica on. Our compounding professionals can provide addi onal therapeu c op ons by preparing the drug in an alternate dosage form such as a transdermal gel. Convenient Combina ons ‐ Taking mul ple prescrip ons can be inconvenient and costly. We can combine various compa ble medica ons into a single prepara on that contains the needed concentra ons of each drug ‐ which can simplify a medica on administra on schedule, and improve compliance. Also, a synergis c effect can be achieved when certain medica ons are used in combina on. Sugar, Preserva ve, Dye, or Lactose‐Free ‐Elixirs, syrups, and suspensions may contain preserva ves such as alcohol which can cause reac ons or gastrointes nal irrita on, or sugar which makes the medica on undesirable for pa ents with diabetes. Our compounding specialists can prepare sugar‐free and preserva ve‐free dosage forms. If a pa ent is allergic to a dye or other excipient or has a lactose intolerance, we can compound the medica on without the problem‐causing addi ves. Flavored to Please ‐We flavor medica ons to make them more pa ent‐friendly and increase compliance. Do you know a child who doesn’t like the flavor of his an bio c? We can flavor medica on to taste like a real banana, or watermelon or root beer if preferred. Some mes elderly or chronically‐ill pa ents complain that medica on is too sweet. Coffee flavor may be the answer! Unavailable or Hard‐to‐Find Medica on ‐ Drugs may be temporarily unavailable, and pharmaceu cal companies may stop making products for which there is limited demand. We can usually obtain the needed drug as a bulk pharmaceu cal grade chemical and


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compound a customized formula on. Prac oner‐specific formula ons ‐ Den sts o en develop specific formula ons to meet the unique needs of their pa ent popula on, or acquire “tried and true” formulas during training. We commonly prepare these customized medica ons.

Dental Compounding Customized formula ons available through our compounding pharmacy help both den sts and their pa ents. We customize medica ons to meet each pa ent’s specific needs. Upon a prescrip on order, we can compound: lip balms for viral lesions mouth rinses for aphthous ulcers long‐ac ng capsules for dry mouth transdermal (topically applied) muscle relaxants/pain relievers for TMJ disorder topical anesthe cs plaque disclosure/removal solu ons non‐staining an bacterial rinses oral seda on in freezer pops lollipops for oral thrush mouth rinses to stop oral bleeding during dental procedures for pa ents who take an coagulants mouthwashes for chemotherapy‐induced stoma s dry socket prepara ons “mucosal bandages” to cover ulcerated, infected, or tender areas on the oral mucosa and many more unique prepara ons! Medica ons are manufactured in a limited number of strengths and dosage forms that will sa sfy the needs of most pa ents, due to shelf‐life limita ons and the cost of stocking and distribu ng numerous formula ons of each drug. Using pharmaceu cal grade chemicals and specialized equipment not found in most pharmacies, we can compound medica ons in doses and dosage forms that are not commercially available. We want to op mize the care of every pa ent. Just let us know what you need!

Suppressing the Gag Reflex Various pharmacologic and behavioral therapies have been tried in an a empt to eliminate the gag reflex. The reflex can cause a pa ent considerable discomfort as well as interfere with the dental procedure. The gagging response can be triggered by a variety of extra‐oral (sight of a mouth mirror, taste of prophy paste, sound of a handpiece) and intra‐oral (touching the palate, tongue, or throat) s muli. A response may be the result of a combina on of s muli, making a diagnosis difficult. “The primary assump on of the development of the electrolyte tablet is that altera on of the neural transmission of the vagus and hypoglossal nerves would alter or reduce the gag reflex... An effec ve and quick solu on to the gagging problem could therefore be achieved by devising a safe and quickly administered chemical material that affects the vagus, glossopharyngeal and hypoglossal nerves.” It has been found that an electrolyte lozenge administered and retained intraorally up to 45 minutes before the start of a procedure can stop or suppress the gag reflex. Pa ents should be instructed to suck the lozenge un l it is fully dissolved. The electrolyte lozenge/tablet is par cularly useful when performing a procedure on the mandibular arch. “A er administering the tablet, a mandibular block can be given with much greater ease, which further reduces the gagging reflex. The same holds true for the maxillary arch” where, a er giving the electrolyte tablet, palatal anesthesia can be administered more easily. Repeated experimenta on over a six year period found that administra on of some electrolytes worked be er than others to reduce the gag reflex, including: sodium, chloride, bicarbonate, calcium, potassium, phosphate, and magnesium. A tablet containing the first three electrolytes listed was found to be approximately 80‐85% effec ve, while one containing the first five was 98% effec ve. Electrolyte lozenges/tablets can be prescribed for home use for pa ents who can not properly perform oral hygiene procedures due to the gagging problem. Severe gaggers may need to repeat a dose in 15 to 20 minutes. R.D. Westerman, Den stry Today 1991 Dec;10(9):68‐71 Int’l J Pharm Compounding. Jan/Feb 1999; 3(1):46 The successful use of a Benzocaine 2% An gag Lozenge, administered 15 minutes before the start of a dental procedure, has also


been reported. Of course, when using a topical anesthe c, the den st must be certain to warn pa ents to test the gag reflex by drinking water prior to ea ng or drinking other liquids. Int’l J Pharm Compounding. Jan/Feb 2002; 6(1):17 Topical Anesthe cs Local anesthe cs can be used topically to facilitate pain‐free procedures, and some mes eliminate the need for injec ons. Vasoconstrictors can be added to prepara ons to promote local hemostasis, decrease systemic absorp on, and prolong the dura on of ac on. Novel formula ons of topical anesthe cs may prevent pain associated with laser and so ssue procedures; phrenectomies; deep scaling, root planing, and cure age; and prior to extrac on of primary teeth. Approximately 55% of 3051 pediatric den sts responded to a survey conducted by West Virginia University School of Den stry, and indicated that most pediatric pa ents (89%) disliked the taste of topical anesthe cs. There “appears to be a need to develop newer and be er mode of topical anesthe c delivery system in the pediatric dental popula on.”1 Various dosage forms can be compounded to contain the medica ons of the prac oner’s choice. For example, lollipops can be used to administer topical anesthesia to hesitant children, who may prefer a delicious lollipop to a co on swab that is covered with a less palatable anesthe c gel. Medicated lollipops can be dispensed in child resistant containers, and labeled with proper instruc ons. Topical anesthe cs can also be packaged as individual doses in topical syringes or in small jars for pa ents who will need the medica on for mul ple procedures. Den nal hypersensi vity and recurrent disease may necessitate the use of anesthe c during periodontal recall visits. However, an aversion to injec ons may affect pa ent compliance to recall. The overwhelming preference for a non‐injectable anesthe c reveals a strong clinical need for such alterna ves.2 Research at the University of Alabama at Birmingham, School of Den stry indicates that intrapocket administra on of a gel containing lidocaine 25 mg/g plus prilocaine 25 mg/g may be effec ve for pain control for scaling and root planing and may offer an alterna ve to infiltra on anesthesia.3 A Swedish study of lidocaine/prilocaine intra‐pocket anesthe c gel has shown the onset of anesthesia to be 30 seconds a er gel applica on, with a mean dura on of ac on of about 18 minutes.4 If formulated in higher concentra ons or combina ons to enhance potency, topical anesthe cs should be applied using a swab or microbrush and should be kept away from the throat area to avoid numbing the gag reflex. Onset, peak effect, and dura on of analgesia vary depending on formula on. The inclusion of epinephrine (adrenaline) in a topical anesthe c is o en contraindicated in people who suffer from cardiovascular disease or arrhythmias. Dyclonine 0.5% in a mixture of diphenhydramine or promethazine and Maalox (with instruc ons to rinse with 1‐2 tsp every 2 hours and expectorate) has been recommended for therapy of painful oral complica ons secondary to cancer treatment.5,6 Anesthe c troches containing dyclonine 1 mg and diphenhydramine 10 mg have been used to relieve oral inflamma on and irrita on.7 Health Canada’s Therapeu c Products Directorate (TPD) has listed medica ons that can be used “in lozenge form intended to be dissolved in the mouth to help relieve sore throats”. One example is a lozenge containing dyclonine HCl, in a dose of 1 mg to 3 mg. In November 2006, Health Canada issued an advisory regarding an associa on between the local anesthe c benzocaine and a poten ally serious blood condi on known as methemoglobinemia (MHb). MHb is an uncommon adverse reac on known to be associated with benzocaine. This condi on reduces the ability of red blood cells to deliver oxygen throughout the body, which can lead to bluish discolora on of the skin, nausea and fa gue. It can progress to stupor, coma and death. As of November, 2006, Health Canada had received reports of nine cases of suspected MHb associated with the use of benzocaine. None of the reported cases had a fatal outcome. Almost all reported cases of benzocaine‐induced MHb were associated with high‐concentra on prepara ons (14 per cent to 20 per cent benzocaine).8 Please call our compounding professionals for customized topical anesthe cs containing the ac ve ingredients and base of your choice, flavored to please any pa ent’s taste. 1 Pediatr Dent 2001 May‐Jun;23(3):265‐9 2 J Dent 2001 Mar;29(3):173‐9 3 J Periodontol 2001 Jul;72(7):895‐900 4 J Clin Periodontol 2001 May;28(5):453‐8 5 Heddie Sedano, D.D.S., (accessed July 2004) 6 h p://www.dent.ucla.edu/pic/members/cancer/treatment.html 7 Int J Pharm Compound. 2000 Jan/Feb;4(1):55 8 h p://www.hc‐sc.gc.ca/ahc‐asc/media/advisories‐avis/2006/2006_115_e.html


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Topical Anesthe c Offers “Genuine Pa ent Comfort” During Rou ne Prophylaxis A double‐blind study conducted by Milton Hodosh, DMD, et al. of the Harvard University School of Dental Medicine used pa ent volunteers chosen at random. A 35% potassium nitrate/20% benzocaine/10% tetracaine/aqueous hydroxyethyl cellulose gel was applied to the teeth and gingiva of 100 pa ents prior to hygienist‐administered maintenance treatments. As a control, 100 pa ents received hydroxyethyl cellulose without the ac ve agents. The potassium nitrate/tetracaine/benzocaine applica on effec vely anesthe zed the teeth and gingiva so that these maintenance treatments could be performed rou nely with genuine pa ent comfort. Gen Dent. 2007 Jul‐Aug;55(4):312‐5 Comment: The above prepara on may be par cularly useful for specific sensi ve areas, but when full mouth sensi vity is an issue, den st may wish to consider Phenol Mouth Rinse (below). Phenol Mouth Rinse for Topical Anesthesia by Jack Storey, D.D.S., Pennsylvania For adults repor ng sensi vity during prophylac c procedures, we use phenol 1.5% as a mouth rinse or swab the gingival using a co on applicator. We have used this prepara on for approximately 10 years, and have found flavored phenol mouth rinse to be well accepted and appreciated by our pa ents and to be a very effec ve short‐ac ng topical anesthe c, and have seen no side effects in our pa ents. Comment: Various flavoring op ons are available. Dyclonine Topical Anesthe c Solu on Dr. Michael DiTolla, Director of Clinical Research and Educa on at Glidewell Laboratories in Newport Beach, CA, noted (Chairside Vol. 3, Issue 1, page 10: Clinical Tips) that formerly, “there was a product named Dyclone, which was a topical anesthe c in liquid form that pa ents could swish for one minute to anesthe ze gingival and palatal ssues. It was fantas c for hygiene pa ents who need some anesthesia but didn’t want local infiltra ons of blocks. It also worked well for needle‐phobic hygiene pa ents, and for pa ents who gag during impressions.” He notes that he now uses a compounded dyclonine prepara on “prior to digital X‐rays on pa ents who are worried about gagging” and “for periodontal probing on pa ents with inflamma on as well as for gross debridement pa ents who are sensi ve”. According to FDA Docket No. 2004P‐0051, it was determined that Dyclone (Dyclonine HCl) 0.5% and 1.0% topical solu ons were NOT withdrawn from sale for reasons of safety or effec veness, and therefore Dyclonine HCl 0.5% and 1.0% Topical Solu ons are listed in the “Discon nued Drug Product List” sec on of the Orange Book. Unlike the original product which had an unpleasant taste, compounded dyclonine topical anesthe c solu on can be formulated in mint and several other flavors.

“Miracle Mouthwashes” & more! Compounding dental mouthwashes or rinses may offer numerous advantages over commercially available dosage forms. It is desirable to compound mouthwashes using pharmaceu cal grade bulk powders as a source of ac ve ingredients (an bio cs, anesthe cs, etc.) versus the common prac ce of combining available liquids due to concerns of palatability, flavor (different products have different flavors, which may not be compa ble), limit of alcohol content, and elimina on of dyes used to color liquid prepara ons which may stain exposed mucosa. Stability and compa bility are significant issues when drugs are manufactured and are required to endure the distribu on cycle and have extended shelf‐life as they are stocked in warehouses and pharmacies. Each manufactured product has numerous ingredients that may contribute to compa bility or stability problems, but may need to be included so that the product can maintain its taste, purity, or consistency. If a preserva ve is necessary but a commercial product is diluted by mixing with other products, then the preserva ve may drop below its effec ve concentra on. When a medica on is prepared at the me it is needed to meet the needs of a specific pa ent, many of these concerns can be eliminated. Compounding allows countless ac ve ingredients to be incorporated into customized mouthwashes, gels, troches, etc. For example, to treat periodontal disease, an bio cs can be formulated as a mouthwash, or added to an oral adhesive paste or a plas cized gel that will maintain the contact between the ssue and medica on for a longer period of me.


Many prac oners are familiar with formula ons used to treat stoma s, such as Kaiser’s, Kraemer’s, Powell’s, Reynold’s, Stanford’s, and T‐N‐D‐D (tetracycline, nysta n, diphenhydramine, and dexamethasone). Various prepara ons are also available to treat burning mouth syndrome. chemotherapy or radia on‐induced mucosi s. Anesthe c/analgesic and an bio c/an ‐infec ve mouthwashes are o en requested. We can compound mouthwashes that are alcohol‐free which can reduce burning of irritated mucosa. sugar‐free to reduce cariogenic poten al and for diabe c pa ents. flavored to please each pa ent. Ingredients that are commonly requested for inclusion in mouthwash formula ons include diphenhydramine, lidocaine, tetracycline, hydrocor sone, nysta n, chlorpheniramine, zinc chloride, phenol, glutamine, dexamethasone, 2‐Deoxy‐D‐Glucose, and fluoride. Topical Treatment for Radia on or Chemotherapy‐Induced Oral Mucosi s “Mucosi s is a common adverse event related to many an neoplas c regimens... Ketamine is a potent N‐methyl‐D‐aspartate (NMDA) receptor channel blocker that can lead to decreased nociocep on and inhibit the inflammatory cascade… Also, ketamine acts on a number of other pathways that may a enuate pain.” Ryan et al. of the Department of Pharmacy, University of California San Diego, La Jolla, CA, sought to determine if an oral ketamine “swish and expectorate” mouthwash was a safe and effec ve method to alleviate mucosi s pain. A retrospec ve chart audit was performed on eight pa ents who received ketamine mouthwash (20 mg/5 ml) for refractory mucosi s pain. All eight pa ents had mucosi s pain refractory to a mucosi s mixture (lidocaine, magnesium/aluminum hydroxide, and diphenhydramine) and opioids. An improvement in mucosi s pain was seen in over half (5/8) of the pa ents. Four of eight pa ents had adverse effects that could have been associated with the ketamine mouthwash; all side effects were transient and subsided when the ketamine mouthwash was stopped. They concluded that a ketamine mouthwash administered using the “swish and spit” technique may be a viable treatment op on in refractory mucosi s pain. “Magic mouthwashes” are topical solu ons or suspensions prepared to relieve symptoms of various oral pathologies. A study conducted at the Department of Clinical Pharmacy, University of California, San Francisco, described the usage of topical oral solu ons in pa ents experiencing chemotherapy‐induced oral mucosi s (CIOM), and surveyed the care of oral mucosi s provided to pa ents by clinical oncology pharmacists in ins tu onal se ngs. Forty ins tu ons returned surveys during the study period. The top five ingredients used to compound “magic mouthwash” were reported to be diphenhydramine, viscous lidocaine, magnesium hydroxide/aluminum hydroxide, nysta n and cor costeroids. Most ins tu ons administer the mouthwash every 4 hours or every 6 hours. J Palliat Med. 2009 Nov;12(11):989‐91. J Oncol Pharm Pract. 2005 Dec;11(4):139‐43. Glutamine Suspension to Prevent Mucosi s in Pa ents Undergoing Bone Marrow Transplant Oral mucosi s is a common and debilita ng side effect of the regimens that use high‐dose chemotherapy with or without radia on for pediatric bone marrow transplanta on. There has been limited success in preven ng or trea ng mucosi s. Administra on of glutamine, which is a nitrogen‐rich amino acid found in the body, has emerged as a possible method of preven ng oral mucosi s in pa ents undergoing bone marrow transplanta on. Glutamine is a nutrient for rapidly dividing cells and the major energy source for intes nal epithelium. Administra on of glutamine suspension 2 g/m2/dose (maximum dose of 4g), swish and swallow twice daily on days of chemotherapy and for at least 14 addi onal days, resulted in significant ameliora on of stoma s (dura on of mouth pain was 4.5 days less when compared to placebo). The severity of oral pain was also reduced significantly when glutamine was provided with chemotherapy ‐ the amount of days mucosi s restricted oral intake to so foods was 4 days less with glutamine. No toxicity of glutamine was observed. Oral glutamine offers a safe, simple and useful measure to increase the comfort of many pa ents at high risk of developing mouth sores as a consequence of chemotherapy. J Pediatr Oncol Nurs. 2007 Jan‐Feb;24(1):41‐5 Bone Marrow Transplant. 2005 Oct;36(7):611‐6 Am J Ther 1995 Nov;2(11):850‐857


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Misoprostol: Mucosal Protectant and An ‐Secretory Misoprostol is a synthe c prostaglandin E1 analogue, with mucosal cytoprotectant and an secretory proper es. A mouthrinse containing misoprostol and lidocaine in a non‐irrita ng neutral vehicle can be used to provide immediate pain relief and aid in the healing of the oral cavity. A mucoadhesive powder containing misoprostol can be used to aid in the healing of mucosal ulcers and irrita ons. “It is applied by using a powder ‘puffer’ or by direct applica on of the powder to the affected area. The carriers will hydrate and adhere to the mucosal surface, keeping the misoprostol in prolonged contact with the area.” Int’l J Pharm Compounding. May/June 2000; 4(3):211‐212 Int’l J Pharm Compounding. Jan/Feb 1999; 3(1):48 Am J Ther 1995 Nov;2(11):850‐857 Protec on from Radia on‐Induced Oral Mucosi s by Misoprostol, a Prostaglandin E(1) Analog: A Placebo‐Controlled, Double‐Blind Clinical Trial. Hanson WR, Marks JE, Reddy SP, Simon S, Mihalo WE, Tova Y. Loyola‐Hines Department of Radiotherapy, Hines VA Medical Center, Hines, IL, USA. Misoprostol, a prostaglandin E(1) analog, is an effec ve radioprotector in animal studies. Based on this evidence, a prospec ve, randomized, placebo‐controlled, double‐blind study was conducted to determine if misoprostol protected the oral and pharyngeal mucosa of irradiated head and neck cancer pa ents from radia on mucosi s. Postsurgical pa ents who had no detectable cancer and who were referred for postopera ve irradia on were candidates for this study. Thirty‐four Hines VA and 35 Loyola University pa ents were accrued (69 total) over a 2‐year period. A misoprostol tablet (200 mu;g) or an iden cal placebo tablet was dissolved in water and administered as an oral rinse daily about 20 min before irradia on. Conven onal frac onated radiotherapy, consis ng of five weekly doses of 2 Gy day(minus sign1), was delivered. The degree of mucosi s was scored on a scale from 0 (no mucosi s) to 4. In the 17 pa ents randomly assigned to the misoprostol arm at the Hines VA, no advantage was seen compared to the 17 placebo‐treated pa ents. However, there was significantly less mucosi s (p < 0.01, analysis of variance) from weeks 3‐‐6 in the 17 pa ents treated with misoprostol at Loyola compared to the 18 placebo‐treated pa ents. Several problems in the study were iden fied at the VA, including adherence to the protocol design. Other problems such as adequate mucosi s scoring, radia on sca er from fillings, and, in par cular, adequate ming between misoprostol and irradia on were iden fied at both loca ons. Absorp on studies in healthy volunteers showed significant plasma levels at 10 min a er an oral rinse, sugges ng that ini al clinical trials should be confined to topical misoprostol un l more is known regarding the effect of misoprostol on tumors. The results of this pilot study suggest that misoprotol may protect the oral and pharyngeal mucosa from radia on‐induced mocosi s if adequate me between topical administra on and radia on is allowed. Budesonide Rinse for Treatment of Inflammatory Disease of Oral Mucosa Local immunosuppressive therapies without systemic effects offer an advantage in management of immune/inflammatory oral mucosal condi ons. At the University of Illinois at Chicago, College of Den stry, topical budesonide rinses (3 mg/10 ml) were prescribed to pa ents with mucosal disease that was resistant to other interven ons, with instruc ons to rinse for 3 to 5 minutes three mes daily and expectorate. Pa ents with oral manifesta ons of paraneoplas c pemphigus (PNP, an autoimmune mucocutaneous disease) and gra ‐versus‐host disease (GVHD, an immunologic/rejec on response that may occur a er transplanta on) and other immune‐mediated mucosal disease may develop symptoma c severe oral ulcera on, erythema, lichenoid and lupus‐like changes, and dryness of the oral mucosa due to involvement of the salivary glands. The treatment of choice for oral PNP and GVHD is the administra on of steroids and other immunosuppressive agents o en over prolonged periods of me. Management of oral microbial flora to reduce caries risk and gingival/periodontal inflamma on and candidiasis is o en needed. Pa ents with PNP and GVHD who had not responded to standard therapy were successfully managed with budesonide rinse. Budesonide is a glucocor coid with high topical an ‐inflammatory ac vity, but low systemic bioavailability and therefore has fewer systemic effects compared with other glucocor coids, including beclomethasone dipropionate and prednisolone. Budesonide is well tolerated during long‐term topical treatment of oral manifesta ons. Its strong affinity for cor costeroid receptors enhances its potency for the treatment of local oral immune‐mediated condi ons and is very desirable when systemic effects must be avoided, are not needed, or when the oral mucosa is the only site not responding to high doses of systemic cor costeroids. The use of budesonide “mouthwash” as a topical treatment may provide enhanced treatment effects for local oral disease while sparing the host of increased systemic immunosuppression associated with higher cor costeroid usage.


While combined immunosuppressive systemic therapy may s ll be required for management of PNP or GVHD, the first choice for management of oral manifesta ons may be topical budesonide, which in two case reports, reduced the surface area of ulcera on and severity of erythema more than 60%. In this report, both pa ents tolerated budesonide rinse well with no side effects or complica ons reported. (Oral candidiasis would likely be the most common side effect and can be controlled with an sep cs and an fungal agents.) In summary, these cases show the poten al value of topical budesonide mouthwash in difficult to manage oral immune‐mediated condi ons with the poten al for enhanced local effect and reduced systemic impact. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Jul;106(1):e11‐7.

Oral mucosi s nega vely impacts quality of life and, as reported by pa ents, is the most debilita ng complica on of head and neck radia on therapy, chemotherapy, and hematopoie c cell transplanta on. In many pa ents, oral mucosi s can lead to modifica on, delay, or cessa on of cancer therapy and ul mately impact cure rates. Topical drugs may reduce the need for systemic pain relievers. However, topical anesthe cs have a short dura on of effect and may cause oral numbness, taste loss, and burning when rinsing on damaged oral mucosa. Doxepin was prepared as an oral rinse (5 mg/mL) and subjects rinsed with 5 mL of the solu on in their mouth for 1 min and expectorated. Forty‐six (90%) of the 51 pa ents reported a reduc on in pain a er rinsing with doxepin. At 5 minutes, on average, pa ents reported a 41% decrease in pain, obtaining a 55.6% reduc on in pain from baseline at 15 minutes. The median dura on of pain reduc on lasted for almost 2½ hours with a maximum pain reduc on of 75%, and was reported as a short period of anesthesia, followed by an extended period of analgesia. The severity of oral mucosi s, as measured by the worst erythema score, was posi vely correlated with the dura on of pain reduc on. The doxepin rinse was generally well accepted by pa ents with oral mucosi s. Discomfort/burning with use was minimal. Anesth Analg. 2006 Aug;103(2):465‐70 Tranexamic Acid for Preven on/Management of Postsurgical Bleeding in An coagulated Pa ents without dose modifica on of oral an coagulants Tranexamic acid is an an fibrinoly c agent, which can be applied topically or used as a mouthwash to prevent post‐surgical bleeding in an coagulated pa ents a er oral surgery or extrac ons, without discon nua on or dose reduc on of an coagulant therapy. The hemosta c effect of tranexamic acid solu on (4.8%) used as a mouthwash was compared with a placebo solu on in 93 pa ents on con nuous, unchanged, oral an coagulant treatment undergoing oral surgery. The inves ga on was a randomized, double‐blind, placebo‐controlled, mul center study. Before suturing, the surgically treated region was irrigated with 10 ml of tranexamic acid (46 pa ents) or placebo solu on (47 pa ents). The pa ents then used the ac ve or placebo solu on as a mouthwash: 10 ml of the solu on for 2 minutes four mes daily for 7 days. In the placebo group, 10 pa ents developed bleeding requiring treatment, while none of the pa ents treated with tranexamic acid solu on had bleeding. Tranexamic acid mouthwash was well tolerated.1 A double‐blind, placebo‐controlled, randomized study of the hemosta c effect of tranexamic acid mouthwash a er oral surgery was conducted in 39 pa ents receiving an coagulant agents because of the presence of cardiac valvular stenosis, a prosthe c cardiac valve, or a vascular prosthesis. Surgery was performed with no change in the level of an coagulant therapy, and treatment with the an coagulant agent was con nued a er surgery. The research concluded that local an fibrinoly c therapy is effec ve in preven ng bleeding a er oral surgery in pa ents who are being treated with an coagulants.2 A two‐day postopera ve course of a 4.8% tranexamic acid mouthwash may be equally effec ve as a 5‐day course in controlling hemostasis for post‐dental extrac ons in pa ents an coagulated with warfarin.3 Tranexamic acid mouthwash was shown to be as effec ve and more cost effec ve than autologous fibrin. This study supports the consensus that dental extrac ons can be performed without modifica on of oral an coagulant treatment.4 Bleeding complica ons and transfusion requirements a er scalings and extrac ons in pa ents with hemophilia have also been significantly reduced by local treatment with tranexamic acid.5, 6 1 J Oral Maxillofac Surg 1993 Nov;51(11):1211‐6 2 N Engl J Med 1989 Mar 30;320(13):840‐3 3 Int J Oral Maxillofac Surg. 2003 Oct;32(5):504‐7 4 J Oral Maxillofac Surg. 2003 Dec;61(12):1432‐5 5 Br Dent J. 2005 Jan 8;198(1):33‐8; discussion 26 6 Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Mar;99(3):270‐5


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Novel Therapies for Oral Infec ons and Aphthous Ulcers Amphotericin B and Nysta n Mouthrinses Amphotericin B and nysta n are potent an fungal agents which are ac ve against most pathogenic fungi like Aspergillus and Candida. Mouthrinses containing these drugs are used for preven ve and cura ve treatment of fungal infec ons like oral candidiasis, which can cause mul ple diseases, especially in cancer pa ents. Mouthrinses are usually prepared in aqueous, saline or alkaline medium. Alkaline medium is effec ve against hyposaliva on and acidity which contribute to the development of mucocutaneous candidal infec ons. Groeschke et al inves gated the stability of extemporaneously compounded mouthrinses containing amphotericin B (7.4 mg/ml) and nysta n (4580.2 IU/ml) in 1.4% sodium bicarbonate (sodium hydrogen carbonate). The stability of these solu ons was tested at different temperatures (4 to 37 degrees C) with or without exposure to light and in two types of containers (glass and polypropylene) over a 15‐day period. The prepara ons were also monitored for color change and pH. Amphotericin B and nysta n were quan fied by high‐performance liquid chromatography (HPLC). At 4 degrees C (refrigera on), amphotericin B and nysta n were stable for 15 days in polypropylene containers. When stored in polypropylene at 37 degrees C (room temperature), with or without light protec on, amphotericin B and nysta n were stable for 3 and 4 days, respec vely. J Pharma Biomed Anal. 2006 May 30 (E‐pub ahead of print) AIDS 1998 Jun 18;12(9):1033‐7 Efficacy of melaleuca oral solu on for the treatment of fluconazole refractory oral candidiasis in AIDS pa ents. Jandourek A, Vaishampayan JK, Vazquez JA Department of Medicine, Wayne State University School of Medicine, Detroit, Michigan 48201, USA. OBJECTIVE: To evaluate the efficacy of melaleuca oral solu on in AIDS pa ents with fluconazole‐resistant oropharyngeal candida infec ons. DESIGN: A prospec ve, single center, open‐labeled study. SETTING: A university‐based inner‐city HIV/AIDS clinic. PATIENTS: Thirteen pa ents with AIDS and oral candidiasis documented to be clinically refractory to fluconazole, as defined by failure to respond to a minimum of 14 days of > or = 400 mg fluconazole per day. Addi onally, pa ents had in vitro resistance to fluconazole, defined by minimal inhibitory concentra ons of > or = 20 microg/ml. INTERVENTIONS: Pa ents were given 15 ml melaleuca oral solu on four mes daily to swish and expel for 2‐4 weeks. MAIN OUTCOME MEASURES: Resolu on of clinical lesions of oral pseudomembranous candidiasis lesions. Evalua ons were performed weekly for 4 weeks and at the end of therapy for clinical signs of oral candidiasis. Quan ta ve yeast cultures were performed at each evalua on. RESULTS: A total of 13 pa ents wereentered into the study, 12 were evaluable. At the 2‐week evalua on, seven out of 12 pa ents had improved, none were cured, and six were unchanged. At the 4‐week evalua on, eight out of 12 pa ents showed a response (two cured, six improved), four were non‐responders, and one had deteriorated. A mycological response was seen in seven out of 12 pa ents. A follow‐up evalua on 2‐4 weeks a er therapy was discon nued revealed that there were no clinical relapses in the two pa ents who were cured. CONCLUSIONS: Melaleuca oral solu on appears to be effec ve as an alterna ve regimen for AIDS pa ents with oropharyngeal candidiasis refractory to fluconazole. Treatment for Recurrent Aphthous Stoma s Recurrent aphthous stoma s (RAS; aphthae; canker sores) is a common ulcera ve condi on of the oral mucosa. Characterized by mul ple, recurrent, small, round, or ovoid ulcers with circumscribed margins, erythematous haloes, and yellow or grey floors, it usually presents first in childhood or adolescence. Its e ology and pathogenesis is not en rely clear, but there is a gene c predisposi on, with strong associa ons with interleukin genotypes, and some mes a family history. Diagnosis is on clinical grounds alone, and must be differen ated from other causes of recurrent ulcera on, par cularly Behçet disease ‐ a systemic disorder in which aphthous‐like ulcers are associated with genital ulcera on, and eye disease (par cularly posterior uvei s). Management remains unsa sfactory as here is no uniformly effec ve therapy for this disease .1 In a clinical randomized crossover trial, minocycline 0.2% and tetracycline 0.25% aqueous oral rinses were assessed in pa ents with frequent episodes of RAS. Minocycline mouthwashes as compared to topical tetracycline rinses resulted in significantly improved pain control, by reducing the severity and dura on of pain. Topical minocycline rinse may be a poten al treatment for other non‐infec ous inflammatory ulcera ve oral mucosal diseases.2,3 A single‐blind controlled study evaluated the therapeu c efficacy and safety of lac c acid 5% mouthwash, one teaspoonful three

mes daily before meals, in the treatment of pa ents with RAS. The response rates a er 3 days and 7 days of therapy were 63.6%


and 90.8% for lac c acid versus 8.8% and 35.7% for placebo. No significant side effects were no ced apart from mild irrita on in 2 of 36 pa ents using lac c acid. The study concluded that lac c acid 5% mouthwash is a effec ve mode of therapy for pa ents with RAS and had significantly reduced the signs and symptoms of the disease, especially when compared with placebo. The mechanism of ac on may be related to increasing spontaneous secre on of endothelial growth factor from kera nocytes.4 1 Br J Oral Maxillofac Surg. 2008 Apr;46(3):198‐206. Epub 2007 Sep 11. 2 Dermatol Online J. 2007 May 1;13(2):1. 3 Spec Care Den st. 2008 Jan‐Feb;28(1):27‐31. 4 Dermatol Online J. 2006 Dec 10;12(7):2. Br J Dermatol 1992 Feb;126(2):185‐8 Topical 5‐aminosalicylic acid: a treatment for aphthous ulcers. Collier PM, Neill SM, Copeman PW Department of Dermatology, Westminster Hospital, London, U.K. A double‐blind placebo controlled trial of 5% 5‐aminosalicylic acid (5‐ASA; mesalamine) cream for the treatment of oral aphthous ulcers was carried out on 22 subjects. The cream or a placebo (11 pa ents each) was applied to the ulcers three mes daily for up to 14 days. Daily discomfort was reduced by half (P less than 0.01) and less pain (P less than 0.05) was experienced by the treated group. Treatment with 5‐ASA shortened healing me (7 vs. 11 days, P less than 0.01) and reduced the difficulty in ea ng (P less than 0.05). No significant side‐effects were reported. We believe 5‐ASA cream to be an effec ve treatment for aphthous ulcers. J Oral Pathol Med 2001 Nov;30(10):611‐7 The treatment of oral aphthous ulcera on or erosive lichen planus with topical clobetasol propionate in three prepara ons: a clinical and pilot study on 54 pa ents. Muzio LL, della Valle A, Mignogna MD, Pannone G, Bucci P, Bucci E, Sciubba J. Ins tute of Dental Sciences, University of Ancona, Ancona, Division of Oral Pathology and Medicine, University of Naples Federico II, Naples, Italy and Department of Dental Medicine, Long Island Jewish Medical Center, New Hyde Park, New York BACKGROUND: This study evaluated the clinical use of a cor costeroid in three prepara ons (topical clobetasol propionate ointment, clobetasol propionate in an oral analgesic base, and clobetasol propionate in an adhesive denture paste). METHODS: Fi y‐four pa ents (34 males and 20 females) with a history of vesiculo‐ulcero‐erosive oral lesions were selected: 24 with oral erosive lichen planus and 30 with aphthae. The subjects enrolled were randomly divided into three groups, each of 18 pa ents (10 with aphthae and 8 with lichen planus): the first was treated with topical clobetasol propionate ointment (0.05%) directly on the lesion(s) three

mes a day; the second with clobetasol propionate in an adhesive denture paste in equal amounts (1:1) two mes a day; the third with clobetasol propionate in an oral analgesic base (Orabase‐B) in equal amounts (1:1) two mes a day. Each subject scored his or her symptoms daily from most severe (7) to none (0) by verbal assessments using a categorical scale. RESULTS In all cases, the administra on of the cor costeroid was effec ve in producing remission of symptoms in each group of pa ents. Significant differences (P<0.05) between groups were determined by the Kruskal‐Wallis test. The Dunn test was used in order to detect which group differs from the others; clobetasol and adhesive denture paste correlated with an early remission of pain in lichen and apthous lesions. CONCLUSION: The results suggest that topical applica on of clobetasol in an adhesive denture paste is an effec ve drug for symptoma c oral vesiculo‐erosive and/or ulcera ve lesions. Deglycyrrhizinated Licorice for Canker Sores Licorice has a long history of medicinal use in Europe and Asia. Licorice can be processed to remove glycyrrhiza, resul ng in deglycyrrhizinated licorice (DGL), which does not appear to share the poten al metabolic disadvantages (hypertension, hypokalemia, and fluid reten on) associated with high doses of licorice. Pa ents with aphthous ulcers (canker sores) who used DGL mouthwash experienced 50‐75% improvement within one day followed by complete healing of the ulcers by the third day.

h p://www.nlm.nih.gov/medlineplus/druginfo/natural/pa ent‐licorice.html J Assoc Physicians India 1989 Oct;37(10):647


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Treatment for Gingivi s Folate Mouthwash for Gingivi s Folic acid (folate) has been clinically tested as a mouthwash prepara on to assess its benefit in trea ng gingivi s. One study showed significant improvement compared to placebo a er 4 weeks of using a folic acid mouthwash. In this controlled study involving 60 non‐pregnant adults, dietary folic acid intake did not correlate with treatment results, sugges ng the importance of applying folic acid topically to the gums. Subjects had greater than 20 teeth, visible gingival inflamma on around 6 or more teeth, no complicated medical history, and were currently not receiving periodontal treatment or medica on, and not wearing dentures. Subjects used 5 ml of mouthwash (containing 5 mg folate) twice daily for 4 weeks, rinsing for 1 min before expectora ng. The oral examina on was repeated a er 4 weeks. J Clin Periodontol 11(9):619‐28 Ini ally, groups were similar except that the experimental group exhibited more bleeding sites at the outset, but a er 4 weeks, the experimental group showed a significant decrease in mean number of color change sites and in bleeding sites compared with control group. Dietary analysis showed that few subjects ate greater than 0.2 mg of folate daily; however, the level of dietary folate did not correlate with changes in inflamma on in experimental subjects. Folate mouthwash appears to have an influence on gingival health through local rather than systemic influence. In a double‐blind study of 30 pregnant women, the effects of folic acid mouthwash, folic acid tablets, or placebo were evaluated. A er 28 days, folate serum levels increased significantly in both groups receiving folic acid, but only the group receiving the folic acid mouthwash showed a highly significant improvement in a Gingival Index. J Clin Periodontol 9(3):275‐80 Folate for Phenytoin Hyperplasia There have been some reports that folic acid inhibits phenytoin‐induced gingival hyperplasia. Drew et al. conducted a double‐blind study to clinically quan fy the effects of both systemic and topical administra on of folic acid on phenytoin‐induced gingival overgrowth in man. For a period of 6 months, one group of phenytoin pa ents received 2 daily topical applica ons of a folate solu on. An addi onal group received 2 daily doses of systemic folate while a control group received placebo medica on. Results indicate that throughout the 180‐day period of the study, the topical folate significantly inhibited gingival hyperplasia to a greater extent than in either the systemic folate or placebo groups. J Clin Periodontol 14(6):350‐6 Azithromycin for the Treatment of Cyclosporin‐Induced Gingival Hyperplasia Gingival hyperplasia and inflamma on are well recognized complica ons of cyclosporin A therapy in renal transplant pa ents. Numerous studies have reported that 500 mg/day of azithromycin for 3 consecu ve days induced par al or even complete regression of hyperplasia, especially when administered early in the process. Nephrol Dial Transplant 12(12):2694‐7 Transplanta on 65(12):1611‐5 Cime dine Oral Rinse Enhances the An bacterial Func on of Neutrophils in Gingival Crevices Van Dyke et al of Boston University, Goldman School of Dental Medicine, conducted three coordinated mechanism‐of‐ac on clinical studies to examine the effects of topical cime dine rinse on neutrophil func on in the gingival crevice. The first study was a randomized, double‐blind, placebo‐controlled, 28‐day experimental gingivi s study involving 21 healthy adults, in which subjects rinsed twice a day with placebo or 0.5% cime dine rinses. The second and third studies were placebo‐controlled, 9‐week, three‐period (each of 3 weeks' dura on), longitudinal studies involving seven and nine adults with moderate periodon s, respec vely. Subjects rinsed twice a day during periods 1 and 3 with placebo and during period 2 with 0.5% cime dine. In the first study, the mean number of phagocytosing neutrophils was increased to a sta s cally significant degree in the cime dine group (31.1 cells/subject) versus the placebo group (13.7 cells/subject) at day 28. In addi on, a sta s cally significant increase in bacterial killing was observed in the cime dine rinse group where 63.4% of bacteria in the neutrophils were killed compared to 46.2% in the placebo group. Addi onal data from the other two studies support these findings. Collec vely, these studies provide evidence


that topical 0.5% cime dine oral rinse enhances the an bacterial func on of crevicular neutrophils. J Periodontol. 2005 Jun;76(6):998‐1005

Therapy for Angular Cheili s & Lip Lesions Angular cheili s (Perlèche, stoma s) occurs at the labial commissures and classically appears as a red and white fissured lesion with a faint white‐yellowish coa ng. It is commonly bilateral in presenta on. In HIV nega ve individuals, angular cheili s is generally associated with loss of the ver cal dimension or in pa ents who overclose with resul ng fold at the sides of the mouth in which saliva collects. This situa on is generally observed in elderly pa ents who may have sagging facial muscles and ill‐fi ng dentures which produce a fold in the angle of the mouth, and is also o en seen in persons undergoing radia on therapy. Overclosure can also occur during sleep by compression of the cheek against the pillow and consequent drooling of saliva. Some pa ents have the habit of constantly licking their lip at the level of the commissure with consequent infec on with Candida albicans. The incidence of angular cheili s and lip fissures appears to be increased in people with Down syndrome. In one study, lip fissures were seen in at least one‐quarter of Down syndrome pa ents, and angular cheili s was also found in a similar percentage. Another possible predisposing factor for angular cheili s is trauma to the commissure induced by prolonged dental treatment with consequent superimposed infec on with Candida albicans. Oral candidal infec on almost always involves a compromised host. The compromise may be local or systemic. Local factors include decreased saliva on and the wearing of dentures. Systemic factors include diabetes mellitus, pernicious anemia, and AIDS. In some pa ents with angular cheili s, genesis of the lesions is secondary to monilial infesta on. Otolaryngol Clin North Am. 26(6):1069‐89 ‐ J Am Acad Dermatol. 31(3 Pt 2):S51‐5 ‐Br J Dermatol. 2002 Jul;147(1):37‐40 Numerous medica ons are used to treat angular cheili s, including nysta n, clotrimazole, ketoconazole, fluconazole, and itraconazole. An ‐fungal medica ons are commercially available as topical creams and ointments, troches and pas lles, and oral dosage forms.

Preven on of Dry Socket by Local Applica on of Oxytetracycline/Hydrocor sone Suspension The occurrence of localized ostei s (dry socket) following extrac on of impacted mandibular third molars is approximately 25‐30%. In a study by Julius et al of Creighton University, ninety impacted mandibular third molars (45 le and 45 right in 45 pa ents) were removed. Gelfoam saturated with oxytetracycline/hydrocor sone suspension was placed in the alveolus on the le side, and the right alveolus served as a control. In the treated sockets, only 3 cases of localized ostei s developed compared with 13 cases in the untreated sockets. In addi on, the untreated group presented with dry sockets judged to be more severe. The pharmacologic ra onale for use of a locally effec ve cor costeroid in extrac on sites to reduce the incidence of dry sockets is that these hormones suppress the produc on of plasmin. The results of this study indicate that oxytetracycline/hydrocor sone suspension is safe and effec ve for decreasing both the incidence and severity of localized ostei s following the removal of impacted third molars, par cularly bony impac ons. It appears that the greater the trauma associated with the extrac on, the greater the protec ve effect of the prepara on. J Oral Maxillofac Surg 1982 May;40(5):285‐6 Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2000 Sep;90(3):282‐4 Alveolar ostei s preven on by immediate placement of medicated packing. (9% eugenol, 36% balsam of Peru, and 55% petroleum jelly). Bloomer CR. OBJECTIVE: The purpose of this study was to evaluate whether immediate placement of medicated dry socket packing would decrease the incidence of alveolar ostei s (dry socket) with lower third molar extrac ons. STUDY DESIGN: In 100 pa ents, 200 lower third molars were extracted. One half of the sockets were packed to the crest of the alveolar ridge with a one‐quarter‐inch radiograph‐detectable filament gauze that contained 9% eugenol, 36% balsam of Peru, and 55% petroleum jelly. The medicated packing was removed 1 week a er surgery. None of the pa ents were taking an bio cs. Pa ents were instructed to increase their oral hygiene before and a er surgery and were to use 0.12% chlorhexidine gluconate 2 days before and 3 days a er surgery. RESULTS; Two hundred bilateral lower third molars of varying difficulty were extracted. The overall alveolar ostei s rate was 34 (17%). The immediately packed lower third molar sites had an alveolar ostei s rate of 8 (8%). The sockets that were not packed with medicated packing the day of surgery had an alveolar ostei s rate of 26 (26%). The difference was sta s cally significant (P =.001). CONCLUSION: The results of this study suggest that placement of medicated dry socket packing immediately a er lower third molar extrac on decreases the alveolar ostei s rate.


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Treatment for Dry Mouth (Xerostomia), Post‐Radia on Xerostomia and Sjögren’s Syndrome Pilocarpine Lozenge Pa ents with dry mouth post‐radia on, from Sjogren’s syndrome, or a side effect of a medica on may have oral discomfort and pain, increased suscep bility to dental caries, frequent oral infec ons, and difficulty in speaking, chewing, and swallowing, which can lead to severe oral disease and nutri onal deficiencies. Xerostomia nega vely affects quality of life and should not be considered a trivial complaint. Pilocarpine is a cholinergic agent that s mulates residual‐func oning exocrine glands and may re‐establish saliva produc on in these individuals. Several studies have demonstrated the efficacy of systemic administra on of pilocarpine HCl in individuals with post‐radia on xerostomia and Sjogren’s syndrome, and have shown pilocarpine to be safe in oral dosages ranging from 2.5 to 10 mg. Side effects, ranging from transient swea ng, urinary frequency and headache, are dose‐dependent. Pilocarpine is indicated for the treatment of xerostomia secondary to radia on therapy of the head and neck. In a study by Vivino et al., pilocarpine at oral doses of 2.5mg and 5mg four mes daily significantly increased saliva produc on and alleviated symptoms of dry mouth when compared to placebo. The higher dose produced the most improvement but also the highest incidence of adverse effects, such as swea ng, diarrhea, and urinary frequency. Radiotherapy injures the parenchyma of the salivary glands, leading eventually to fibrosis and secretory hypofunc on. The effects are dose‐related and permanent, resul ng in post‐radia on xerostomia. Pa ents with radia on‐induced xerostomia produce li le or no saliva. As a result, they have oral discomfort and pain, greatly increased suscep bility to dental caries, frequent oral infec ons, and difficulty in speaking, chewing, and swallowing. These condi ons can lead to severe oral disease and nutri onal deficiencies. Although not life threatening in itself, xerostomia significantly affects the quality of life of the sufferer and should not be considered a trivial complaint. In a double‐blinded, placebo‐controlled trial, 33 head and neck cancer pa ents (avg age 50, with xerostomia of greater than 3 months dura on, and who had evidence of salivary flow upon s mula on with paraffin chew) were assigned randomly to receive Salagen® (pilocarpine tablet), a compounded pilocarpine HCl lozenge (3 or 5mg) or placebo lozenge. A subjec ve evalua on was undertaken through the use of visual analog scales before and at 180 minutes a er treatment. The percentage of pa ents with decreased feeling of oral dryness, sore mouth or speaking difficul es a er taking 5 mg pilocarpine lozenge was greater than pilocarpine tablet or placebo. Subjec ve and objec ve improvements in the signs and symptoms of xerostomia in the pa ents may be due to the mechanical s mula on and local effects afforded by the lozenge because an increase in whole saliva produc on was observed a er complete dissolu on (at 0 minutes). At the School of Den stry, The University of Western Australia, a pilot study inves gated whether pilocarpine dissolved in ar ficial saliva and administered in a mouth spray would be effec ve in relieving radia on induced hyposaliva on. Twenty‐three pa ents with radia on induced hyposaliva on were recruited for a randomized, double‐blind inves ga on. Subjects were randomly allocated to placebo or control medicaments used for eight weeks. All subjects were evaluated for the severity of their xerostomia associated symptoms prior to administra on of the spray and again eight weeks later. Pa ents taking pilocarpine (with base salivary flow rates > 0ml/min) demonstrated improvement in s mulated and uns mulated salivary flow rates. The results indicated that provided residual func oning salivary ssue exists, pilocarpine formulated as a mouth spray is effec ve and warrants further inves ga on. Aust Dent J. 2006 Dec;51(4):333‐7. Archives of Oral Biology. 2011 April; 56(4): 395‐400 Arch Intern Med. 1999; 159:174‐181 Int’l J Pharm Compounding. Sep/Oct 2000; 4(5):381 Aust Dent J 2002 Sep;47(3):249‐53

Since an increased risk of side effects may occur following oral administra on of pilocarpine, topical pilocarpine may be an alterna ve. In a double‐blind, placebo‐controlled study that compared a commercially produced

pilocarpine tablet, a compounded pilocarpine lozenge, and placebo, pa ents who received the compounded lozenge reported the most improvement in oral dryness, sore mouth or speaking difficul es.

Topical administra on of pilocarpine offers several benefits: • it is easy to administer • there is mechanical salivary s mula on • it allows prolonged and increased topical contact • there is a poten al decrease in systemic effects In addi on, local administra on (as opposed to oral, systemic administra on) affect minor salivary glands which have a wide


distribu on throughout the oral cavity. Although minor salivary gland output is small (approximately 10% of the total salivary output) compared with that of the major glands, they account for 70% of the total mucin in saliva. Saliva mucins are reported to provide important protec on of oral ssues from chemical and mechanical trauma. Pa ents should be instructed to allow the lozenge to dissolve in the mouth without chewing. Saliva Subs tute for Dry Mouth/Throat Saliva replacement is an important adjunct to relieving the symptoms of xerostomia in pa ents with Sjögren’s Syndrome. Saliva subs tutes which contain thickening agents like carboxymethylcellulose are used because water alone can not adequately moisten and lubricate the oral mucosa and teeth. Dry mouth or throat secondary to a number of condi ons can be relieved with a customized saliva subs tute that can be administered throughout the day and night and can be flavored to please each pa ent. Keeping the mucosal membranes moist can improve comfort for the pa ent and minimize irrita on and the risk of infec on. Int’l J Pharm Compounding. May/June 2000; 4(3):215 Int’l J Pharm Compounding. Sep/Oct 2000; 4(5):340 Xylitol Oral Syrup used Topically to Prevent Dental Caries Worldwide, pediatric dental caries is a prevalent, persistent, and consequen al disease characterized by a low‐level chronicity that o en belies its significance to individual children and those close to them. It is rampant within some subpopula ons, both those of poverty and those of emerging affluence. In the United States, more than 2 in 5 poor children ages 2 to 5 years experience ‘‘early childhood caries’’ (ECC), and nearly half of those affected experience the severe form of this preventable condi on.1 In a double‐blind randomized controlled trial, the School of Den stry, University of Washington, evaluated the effec veness of a xylitol pediatric topical oral syrup to reduce the incidence of dental caries among very young children. One hundred eight children aged 9 to 15 months were screened, and 100 were enrolled and randomized to receive xylitol topical oral syrup (administered by their parents) in one of the following manners: • xylitol 4.00 grams per dose twice daily and sorbitol as one dose per day (Xyl‐2 x group) • xylitol 2.67 grams per dose three mes daily (Xyl‐3x group) • xylitol 2.67 gram dose once a day and two sorbitol doses (control group). The primary outcome end point of the study was the number of decayed primary teeth. Ninety‐four children with at least 1 follow‐up examina on were included in the intent‐to‐treat analysis. The mean follow‐up period was 10.5 months. Fi een of 29 of the children in the control group (51.7%) had tooth decay compared with 13 of 32 children in the Xyl‐3x group (40.6%) and eight of 33 children in the Xyl‐2x group (24.2%). The mean (SD) numbers of decayed teeth were 1.9 (2.4) in the control group, 1.0 (1.4) in the Xyl‐3x group, and 0.6 (1.1) in the Xyl‐2x group. Compared with the control group, there were significantly fewer decayed teeth in the Xyl‐2x group (xylitol 4.00 grams per dose twice daily) and in the Xyl‐3x group (xylitol 2.67 grams per dose three mes daily). The extreme prevalence, rapidly increasing incidence, and very early onset of ECC in the Marshall Island popula on studied by Milgrom et al. of the University of Washington provide excellent condi ons to validate the short‐term (1 year) salutary impact of a xylitol interven on.2 CONCLUSION: Xylitol oral syrup administered topically 2 or 3 mes daily at a total daily dose of 8 g was effec ve in preven ng early childhood caries. 1 Arch Pediatr Adolesc Med. 2009 Jul;163(7):601‐7. 2 J Pediatr. 2010 Jan;156(1):164.

It has been suggested that topical use of xylitol may be helpful for preven on of cervical caries in older individuals and other pa ents with dry mouth.

Tooth Avulsion and Preserva on with Hank’s Balanced Salt Solu on Tooth avulsions cons tute as much as 16% of all trauma c injuries to permanent anterior teeth. Successful replanta on of an avulsed tooth is dependent upon the preven on of progressive root resorp on by minimizing damage to the periodontal ligament (PDL) and mely endodon c treatment. The type of liquid medium used to store avulsed teeth prior to replanta on has been shown to affect the long‐term prognosis. In addi on, it is important to preserve the vitality of the periodontal ligament ssue remaining on the root surface by replanta on of the tooth within 15‐20 min a er avulsion or by immersing the tooth in a suitable storage medium un l it can be replanted. Various media have been compared for their effec veness in preserving the vitality of PDL cells as well as


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preven on of replacement resorp on (ankylosis). Nonphysiological storage, such as homemade saline and sterilizing solu ons always led to root resorp on. Storage in tap water for more than 20 minutes usually led to root resorp on. Research has shown that, in general, milk was be er than saliva or water, Hank's balanced salts solu on (HBSS) and Viaspan® were be er than milk, and Viaspan® was equal to, or be er than, HBSS in preserving PDL. Unfortunately, despite its effec veness, Viaspan® is expensive and is not readily available. Therefore, researchers recommended iden fying the components of an effec ve storage medium, with the aim of developing a for fied HBSS‐based medium. Dent Traumatol. 2003 Apr;19(2):103‐8 Endod Dent Traumatol. 1995 Apr;11(2):76‐89

It may be beneficial for team den sts, coaches, trainers to have a supply of “in date” storage medium available.

3 Mix‐MP: Single Treatment Provides Alterna ve to Extrac on 3Mix‐MP is an endodon c treatment using a combina on of the an bacterial drugs metronidazole, minocycline and ciprofloxacin (3Mix), and macrogol and propylene glycol (MP) under the concept of Lesion Steriliza on and Tissue Repair (LSTR) therapy. In primary teeth, this prepara on allows the den st to do a pulpotomy instead of extrac ng the tooth. 3 Mix‐MP has also been used to successfully disinfect immature permanent teeth. In one study of 991 teeth, 98% of cases were treated successfully, defined as disappearance of acute or chronic clinical symptoms, such as fistulae, abscess forma on, purulent exudates, swelling or bite pain, and par al or full recovery of radiolucent periradicular lesions (if present at ini a on of therapy). On the first visit, the orifice of the root canal was enlarged and 3 Mix‐MP was placed and sealed with glass ionomer cement. During the next visit, the disinfected root canal was prepared, filled with gu a‐percha, and sealed. In some cases, only medica on was given without any other endodon c procedures (non‐instrumenta on endodon c treatment: NIET) and therapy was clinically successful.1 When Ca(OH)2 is combined with 3 Mix‐MP and used as an intracanal medicament in necro c immature permanent teeth, the therapy can help promote further development of the pulp‐den n complex. A retrospec ve study showed regenera ve endodon c treatment with 3 Mix‐MP and calcium hydroxide [Ca(OH)2] produced significantly greater increases in root length than either the mineral trioxide aggregate (MTA) apexifica on or nonsurgical root canal treatment (NSRCT) control groups. The triple an bio c paste also produced significantly greater differences in root wall thickness than either the Ca(OH)2 or formocresol groups.2 MTA and (“triple an bio c paste”) can be used clinically in the treatment of an unsuccessfully resected tooth associated with a large periradicular lesion.3 Case Report: An 8‐year‐old girl presented for the evalua on of right and le maxillary central incisors with crown fractures and luxa on. The right central incisor had a large periapical lesion, which was treated by filling the canal with a ciprofloxacin/metronidazole/minocycline paste. A er 4 months, the pa ent had no symptoms, and a radiograph showed the radiolucency had completely resolved. At the 1‐year follow‐up, a periapical radiograph showed complete root development and apical closure. These results indicate that triple an bio c paste (3 Mix‐MP) is effec ve in disinfec ng immature permanent teeth with periapical lesions.4

Direc ons:

Combine 1 IRM‐size scoop of 3 Mix (triple an bio c) powder and 1 drop of MP liquid on a mixing pad prior to use. For a primary tooth, do pulpotomy without ex rpa ng pulp canals. • Flush with chlorhexidine. • Place 3 Mix‐MP at the bo om of the pulp chamber. • Place protec ve base such as glass ionomer cement, followed by the restora on of choice. For a permanent tooth, if the apex is not closed (immature tooth), the 3 Mix‐MP can be placed in the canal without removing the nerve (or a er the nerve has been removed). The root canal can be completed when a radiograph shows that the apex has closed. 1 h p://iadr.confex.com/iadr/2005Balt/techprogram/abstract_60499.htm 2 J Endod. 2009 Oct;35(10):1343‐9. 3 J Endod. 2009 Nov;35(11):1603‐6. 4 Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Aug;108(2):e62‐5


Topical Medica on to Treat Orofacial Neuropathic Pain Pa ents with unrelen ng pain in the teeth, gingival, palatal or alveolar ssues o en see mul ple den sts and have mul ple procedures performed. Glenn T. Clark, DDS, MS, of the Orofacial Pain and Oral Medicine Center, University of Southern California School of Den stry, Los Angeles, reports that up to one‐third of pa ents a ending the chronic facial pain clinic have undergone prior irreversible dental procedures (such as root canals or extrac ons) for their pain without success. In these cases, if no local source of infec ous, inflammatory, or other pathology can be found, then the differen al diagnosis must include a focal neuropathic pain disorder. The common diagnoses given include the terms atypical odontalgia, persistent orodental pain, or if teeth have been extracted, phantom tooth pain. One possibility is that these pain complaints are due to a neuropathic altera on of the trigeminal nerve. Mul ple causes exist for sustained neuropathic pain including direct nerve injury (e.g., associated with fracture or surgical treatment), nerve injec on injury, nerve compression injury and infec on‐inflamma on damage to the nerve itself. In addi on, some pa ents with chronic temporomandibular joint pain develop a persistent, an ‐inflammatory medica on‐resistant TMJ pain, which may be neuropathic. Sustained nerve pain is commonly seen in pa ents with psychiatric impairment. It may be that the unrelen ng nature of the pain itself alters the pa ent's personality. Treatment includes pharmacologic medica ons which suppress nerve ac vity. The common medica ons used for atypical odontalgia and phantom tooth pain include gabapen n, tricyclics, topical anesthe cs, and opioids. Data suggests that once the pa ent has failed dental treatment and pain persists, in the long‐term, less than 25 percent will have complete pain relief with tradi onal treatment. Earlier treatment, be er pain control, and improved use of nerve ac vity suppression medica ons may help to prevent secondary psychiatric disease from developing and lower the number of treatments which fail to remedy the problem. There s ll exists no clear choice as to the best medica on for the treatment of neuropathic pain. The first and safest approach for persistent neuropathic orodental pain is to apply topical anesthe cs to a empt to suppress nocicep ve ac vity and reverse the neuropathic changes. Usually these medica ons are applied to the focal pain site using a ssue‐covering oral stent as a holding device. The most common topical anesthe c is benzocaine, which can be very helpful in controlling the pa ent’s pain. A tricyclic an depressant such as amitriptyline or a medica on such as gabapen n can be added. The use of mul ple medica ons with different mechanisms of ac on should increase effec veness for condi ons where more than one receptor needs to be targeted. The clinician's goal should be to alleviate pain and distress while keeping medica ons to a minimum effec ve dose. J Calif Dent Assoc. 2006 Aug;34(8):599‐609. Trauma c neuropathies can occur following dental procedures such as extrac ons, endodon c treatment, and dental implant inser on. Pharmacologic treatment is o en accompanied by unpleasant side effects such as seda on and dizziness. Moreover, interac on with other medica ons may contradict the use of these medica ons or prevent their use in the medically compromised or elderly pa ent. An alternate medica on delivery method, in use clinically for several years, is topical medica on. Topical medica ons are used to treat only a specific peripheral target with minimal or no systemic effect. The Department of Diagnos c Sciences, Division of Orofacial Pain, University of Medicine and Den stry of New Jersey, Newark, conducted a study to evaluate the effect of topical medica ons as a single treatment or in combina on with systemic medica ons in the treatment of orofacial neuropathic pain condi ons. A retrospec ve chart review was performed for 39 pa ents who were diagnosed with a neuropathic pain condi on such as deafferenta on pain, trauma c neuroma, or trigeminal or glossopharyngeal neuralgia, and were treated for orofacial neuropathic pain at the Orofacial Pain Clinic. Systemic medica ons commonly used to treat neuropathic pain condi ons include an epilep cs such as carbamazepine, gabapen n, and pregabalin for neuralgic pain or tricyclic an depressants such as amitryptyline and nortriptyline for deafferenta on pain. The topical medica on was formulated by the same compounding pharmacy for all pa ents. The pa ents were asked to apply the topical medica on to the affected area 4 to 6 mes per day. Subjects were divided into 3 groups: topical medica ons only, systemic medica ons only, and a combina on of both. Following treatment, pain level was significantly reduced in all 3 groups. The review concluded that topical medica on as single treatment or in combina on with systemic medica ons can reduce orofacial neuropathic pain severity. “The topical medica on can be ordered from a compounding pharmacy where it can be formulated to contain carbamazepine 4%, lidocaine 1%, ketoprofen 4%, ketamine 4%, and gabapen n 4%. Carbamazepine and gabapen n ... act by suppressing paroxysmal discharges and reducing neuronal hyperexcitability. Lidocaine, which is a local anesthe c, acts by blocking sodium channels, preven ng nerve depolariza on. Ketoprofen has an ‐inflammatory ac vity. Last, ketamine blocks N‐methyl‐D‐aspartate (NMDA) receptors, whose hyperac vity contributes to maintenance of neuropathic pain.” The topical prepara on should u lize penetra on enhancers such as anhydrous gel base and bio‐adhesive copolymers. These are used to carry the medica on transdermally and transmucosally. “The anhydrous gel base is composed of propylene glycol (PG), glycerin, and ethoxy diglycol (EG) in varying percentages depending on depth of penetra on desired.” Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Apr;105(4):466‐9.


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Topical Medica ons for Orofacial Neuropathic Pain The most common neuropathic pain syndromes in the orofacial region include trigeminal neuralgia, trauma c neuropathy; trigeminal neuroma; postherpe c neuralgia; diabe c neuropathy; cancer‐related neuropathy; neuropathy induced by AIDS; and chronic‐con nuous trigeminal nociceptor neuropathy. The pain mechanisms that generate these problems are different for each neuropathy, and treatment protocols need to be structured accordingly. Numerous studies have shown that NMDA‐receptor antagonists such as ketamine and gabapen n, may be useful in the treatment of neurogenic pain. Since there are NMDA receptors in the periphery, topical ketamine may be useful. These medica ons “would be best compounded into a transdermal penetra ng cream and dispensed in a calibrated topical syringe.” Tricyclic an depressants have been used for their central analgesic effect, which occurs through modula on of the serotonin system. While it is known that there are serotonin receptors in peripheral nerves residing outside the CNS, it is unclear if this fact is important to the topical effect of tricyclic an depressants, which are known to block the reuptake of serotonin. Addi onally, cyclobenzaprine, a tricyclic an depressant analog, is used as a muscle relaxant. It has been used for peripheral applica on for muscle trismus and spasm. Several muco‐adhesive bases and oral pastes allow medica ons to be delivered to the intraoral and extraoral ssues with great specificity, and can be used as carrier vehicles for applying other medica ons to the oral mucosa. Vehicles have been developed that provide rapid dermal and mucosa penetra on and can be compounded to contain various medica ons. One example is a pluronic mixture of lecithin and organogel. The organogel provides a hydrophilic vehicle for binding and carrying the added medica on, while the lecithin increases the vehicle’s ability to penetrate the lipophilic epidermal barrier. Changing the ra o of lecithin to organogel moderates the cream’s solubility through the lipophilic membrane. Recently developed anhydrous bases provide a new op on for delivery through lipophilic ssues. Polymer powder is used alone as a protec ve agent (oral bandage) or mixed with a medica on to maintain long‐term contact with the affected oral mucosa being treated. When the powder is puffed onto the ssue, it slowly hydrates as it binds moisture in the oral cavity and forms a thick patch of adhesive gel on the mucosa. As the medica on in this type of oral or mucosal bandage dissolves, it slowly migrates through the polymer matrix to the mucosal surface, where it exerts its effect. J Am Dent Assoc. 2000 Feb;131(2):184‐95 Ask us about specially formulated mouthrinses, medicated lozenges, intraoral gels, and muco‐adhesive pastes. J Orofac Pain 1997 Fall;11(4):346‐52 Topical clonidine for orofacial pain: a pilot study. Epstein JB, Grushka M, Le N Department of Den stry, Vancouver Hospital and Health Sciences Centre, Bri sh Columbia, Canada. An open‐label trial of clonidine, an alpha 2‐adrenergic agonist, was prescribed for pa ents with a clinical diagnosis of oral neuropathic pain or neuralgia involving the oral cavity. Clonidine (0.2 mg/g) was prepared in a cream base and applied four mes daily to the site of pain. Seventeen pa ents were assessed: 10 were diagnosed with neuropathic pain, and 7 with neuralgia. Two of the 17 pa ents had complaints overlapping both neuropathic and neuralgic pain. In the pa ents with neuropathic pain, an overall mean reduc on in severity of burning of 36% (on a 10‐point visual analogue scale) was reported. Half of these pa ents reported clinical improvement; however, no pa ents reported complete resolu on of symptoms. Of the pa ents with characteris cs of neuralgia, 57% improved; and in those who reported improvement, a mean reduc on of approximately 54% was reported. In the 4 pa ents with neuralgia who responded, a 94% reduc on in pain was reported, with complete resolu on of pain in 2 pa ents. This open‐label clinical trial suggests that topical clonidine may be effec ve in the management of some pa ents with oral neuralgia‐like pain, but may have a more limited effect in those pa ents with oral neuropathic pain. Besides type of pain, no other variables predicted which of the pa ents would achieve pain reduc on with topical clonidine. Although confirma on of clinical efficacy requires double‐blind clinical studies, this ini al trial suggests that further study is warranted. J Orofac Pain. 1997 Fall;11(4):353‐62 Effect of systemic versus topical nonsteroidal an ‐inflammatory drugs on postexercise jaw‐muscle soreness: a placebo‐controlled study. Svensson P, Houe L, Arendt‐Nielsen L. Center for Sensory‐Motor Interac on, Aalborg University, Denmark. Certain types of jaw‐muscle pain may be managed with pharmacologic treatment. This study evaluated the effect of topical and


systemic nonsteroidal an ‐inflammatory drugs on acute postexercise jaw‐muscle soreness. Ten men without temporomandibular disorders performed six 5‐minute bouts of submaximal eccentric jaw exercise. The outcome variables were pressure pain thresholds and pain tolerance thresholds at the masseter muscles, and maximum voluntary occlusal force. Surface electromyography from the masseter muscles was used to assess the development of muscle fa gue during the exercise period. Three treatment modali es were tested in a placebo‐controlled, double‐blind approach: (A) placebo gel and placebo tablets; (B) nonsteroidal an ‐inflammatory drug gel (2 g, 5% ibuprofen) and placebo tablets; and (C) placebo gel and nonsteroidal an ‐inflammatory drug tablets (400 mg ibuprofen). The subjects used their medica on 3 mes a day for 3 days in the postexercise period. In the exercise period, the mean power frequency of the electromyography signal, pressure pain threshold, pain tolerance threshold, and maximum voluntary occlusal force decreased significantly (analysis of variance, P < .01). In the postexercise period, the effect of treatment on pressure pain thresholds was significant (F[2,9] = 4.41, P = .02). On day 3, treatment with topical nonsteroidal an ‐inflammatory drugs was associated with significantly higher pressure pain thresholds as compared to treatment with systemic nonsteroidal an ‐inflammatory drugs (P < .05) and placebo (P < .05). Treatment effects on pain tolerance thresholds and on maximum voluntary occlusal force were nonsignificant. The results demonstrated that repeated eccentric jaw exercise caused muscle fa gue and low levels of postexercise pain and soreness. Topical nonsteroidal an ‐inflammatory drugs seem to have some advantages over systemic nonsteroidal an ‐inflammatory drugs for management of exercise‐induced jaw‐muscle pain. Noninvasive Approach for Successfully Trea ng Pain and Inflamma on of TMJ Disorders

Hodosh et al. introduced a topical gel and method for rapidly relieving pain of temporomandibular joint disorder while uniquely inhibi ng the associated destruc ve chronic inflamma on. The gel (composed of 18% potassium complex, 10% dimethylisosorbide, and 72% aqueous hydroxyethyl cellulose gel) was applied and gently rubbed onto the facial skin over the painful TMJ, muscles of mas ca on, and myofacial area as soon as clinicians iden fied the TMJ disorder, as the authors have found that the gel rou nely and predictably provides rapid pain relief and pa ent comfort and speeds restora on of the jaw's func onal abili es, usually within 5 minutes a er it is applied. Complete pain relief occurred in 45 of 54 pa ents in this study within 5 minutes of the first applica on of the gel, and in all 54 pa ents a er the third day of twice daily applica on of the treatment gel. The relief is a ributable to the combined ability of potassium and dimethylisosorbide to inhibit inflamma on and pain. These dynamic results have led the authors to recommend that the gel be applied as a first‐step procedure before trying to defini vely diagnose and treat the cause(s) of the pa ents' pain and dysfunc on. Once the pain has been eliminated as a complica ng factor, a diagnosis and treatment plan concerning the jaw's biomechanical problems may be iden fied and dealt with. The ability to remove pain and inflamma on as a first measure before making a defini ve diagnosis and treatment plan minimizes pa ent anxiety, depression, and psychological concerns. Subsequent diagnosis and treatment of the biomechanical disorder(s) related to TMJ are then more easily and effec vely accomplished. J Oral Implantol. 2007;33(6):365‐70. Temporomandibular joint disorder: therapy with iontophoresis using dexamethasone Schiffman et al of the TMJ and Craniofacial Pain Clinic, School of Den stry University of Minnesota, conducted a double‐blind study to evaluate the short‐term effect of iontophore c delivery of dexamethasone on the signs and symptoms of temporomandibular disorders in pa ents who had concurrent temporo‐mandibular joint disc displacement without reduc on and capsuli s. Twenty‐seven pa ents with this clinical diagnosis were randomized to one of three groups: treatment group (dexamethasone sodium phosphate and lidocaine hydrochloride); control group (lidocaine hydrochloride); and placebo group (pH‐buffered saline). Pretreatment and pos reatment data included items to calculate Helkimo's Anamnes c Dysfunc on index, Helkimo's Clinical Dysfunc on index, the Symptom Severity Index, and the Craniomandibular Index (CMI). The CMI is composed of the Dysfunc on Index (DI) and Muscle Index. Analysis of variance showed no baseline differences on these measures between the three groups. Pos reatment, the treatment group had an increased mean maximal ac ve mandibular opening of 6 mm, increased mean lateral excursion of 1.2 mm to the noninvolved side, and reduced mean DI scores of 0.51 to 0.39. No sta s cally significant decrease in pain symptoms was reported. Analysis of variance showed a significant difference in the DI scores between groups from pretreatment to pos reatment, with the treatment group showing the greatest improvement in the DI scores rela ve to the other two groups. No other ques onnaire items, exam items, or resultant indexes showed sta s cally significant changes in any of the groups. These results suggest that iontophore c delivery of dexamethasone and lidocaine was effec ve in improving mandibular func on in temporo‐mandibular disorders pa ents who had concurrent temporomandibular joint capsuli s and disc displacement without reduc on. J Orofac Pain 1996 Spring;10(2):157‐65


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Iontophoresis allows for the transdermal delivery of ionic drugs from aqueous solu ons, using a low‐level electric current. It is important that iontophore c drug combina ons are compa ble, which in this case means they are stable, without precipitate, and that neither drug has an effect on the ionic charge of another. Cau on is urged regarding the use of IV solu ons for iontophoresis. Commercially prepared solu ons may contain preserva ves that may cause erythema in a sensi ve pa ent. When the e ology of TMJ disorder and pain is neuromuscular, a den st can prescribe and we can compound a transdermal or topical prepara on that contains an ‐inflammatories, anesthe cs, and/or an spasmodics. Topical Diclofenac for TMJ Disorder Osteoarthrosis is a degenera ve condi on of the joints that can affect the temporomandibular joint (TMJ). It causes pain and ar cular rigidity leading to func onal limita ons of the mouth opening. Diclofenac is a non‐steroidal an ‐inflammatory drug (NSAID) that is commonly used to alleviate pain in knee or elbow joints. A study of 36 adults with diagnosed TMJ dysfunc on compared the benefits of topical and oral forms of diclofenac. The results showed that topically applied diclofenac [topical diclofenac solu on 16 mg/ml, apply 0.25 ml=4 mg four mes a day for 14 days] and oral diclofenac (50 mg a er a meal twice a day for 14 days) are equally effec ve in the treatment of symptoms of TMJ dysfunc on. Topical diclofenac has the advantage that it does not have adverse systemic effects, whereas oral diclofenac had untoward effects on the gastrointes nal system. The efficacy of diclofenac topically applied to the TMJ region is explained by the inclusion of dimethyl sulfoxide, which enables a rapid effec ve penetra on into the joint ssues. It is noteworthy that dimethyl sulfoxide favors transuctaneous absorp on when used in a mul ‐dose regime as in this study (four mes daily). Single "as required" applica ons should be avoided because this prac ce results in scarce absorp on of diclofenac. Contact our compounding pharmacy for topical NSAIDs and other customized formula ons. Acta Otorhinolaryngol Ital. 2004 Oct;24(5):279‐83

Oral Implica ons of Menopause According to the American Dental Associa on: “Women have special oral health needs and considera ons that men do not have. Hormonal fluctua ons have a surprisingly strong influence on the oral cavity. Puberty, menses, pregnancy and menopause all influence women’s oral health and the way in which a den st should approach treatment.” Osteoporosis and periodon s represent two highly prevalent diseases associated with advancing age. There is evidence that a pa ent with systemic osteoporosis is likely to have decreased oral bone density, which may impact the success of dental implants and prosthe c devices, and affect other treatment decisions. Further, a pa ent with decreased bone mineral density may be at a higher risk for progression of periodon s. On dental examina on, clinical findings of postmenopausal problems may include decreased saliva produc on, increased dental caries, dysesthesia, atrophic gingivi s, gingivostoma s, periodon s and osteoporosis. Panoramic dental radiographs may reveal calcified caro d artery atheromas. Menopausal women o en report discomfort (pain, burning sensa on), xerostomia, and altered taste sensa ons (salty, peppery or sour). One study noted the prevalence of oral discomfort in postmenopausal women was 46%, compared to 6% for premenopausal women. Eighty percent of burning mouth syndrome pa ents are women whose pain began from 3 years before to 12 years a er onset of menopause. Most menopausal women who complained of oral discomfort experienced relief with estrogen therapy. Hormone replacement therapy (HRT), which slows the rate of bone loss at skeletal sites such as the hip and spine, also appears to reduce the rate of alveolar bone loss in postmenopausal women. HRT use is consistently associated with greater tooth reten on and a reduced likelihood of edentulism in studies of elderly women. Grodstein et al of Brigham and Women's Hospital and Harvard Medical School examined the risk of tooth loss in rela on to hormone use in a prospec ve study of 42,171 postmenopausal women. Overall, the risk of tooth loss was 24% lower in women who were currently using hormones, although there was li le effect for women who had stopped taking hormones. This decreased risk for current hormone users was observed regardless of the dura on of use and was similar for a variety of hormone prepara ons and doses. Although few studies have examined the issue, this research suggests that hormone therapy may reduce tooth loss. Den sts have an opportunity to refer women to determine the appropriateness of HRT for its systemic and oral health benefits. Den sts and other health care professionals can work as a team to assist women in preven ng and coping with problem caused by hormonal imbalance. Our pharmacists recommend the use of individualized doses of bio‐iden cal hormones when hormone replacement therapy is indicated. Bio‐iden cal hormones have exactly the same chemical structure as endogenous human hormones, and therefore are


able to follow normal human metabolic pathways and provide the full range of ac ve hormones that are required by humans. We are also able to compound a variety of prepara ons that may help to relieve some to the oral problems associated with menopause. Examples include electrolyte lozenges and sustained release sialogogues to help with dry mouth, xylitol prepara ons, and various medica ons for burning mouth syndrome. Please call for more informa on on these customized medica ons. Women’s Oral Health Issues. American Dental Associa on, Oral Health Care Series. December, 1995 Med Oral Pathol Oral Cir Bucal 2005 Mar‐Apr;10(2):132‐41 Dent Clin North Am 2005 Apr;49(2):463‐84 J Periodontal 2004 Mar;75(3):408‐12 J Am Dent Assoc 2002 Jan;133(1):73‐81 Compend Con n Educ Dent 2002 Oct;23(10 Suppl):21‐8 Ann Periodontol 2001 Dec;6(1):209‐13

Ask us about customized therapies to meet the specific needs of each pa ent.

Burning Mouth Syndrome Burning mouth syndrome (BMS), also referred to as glossopyrosis or glossodynia (when the burning occurs on the tongue only) is usually described as oral burning pain, some mes with dysesthe c quali es similar to those present in other neuropathic pain condi ons. The dorsal tongue, palate, lips and gingival ssues, individually or in combina on, are the most common sites involved. Bilateral or unilateral oral burning pain has been found to be associated with jaw pain or uncontrollable ghtness, taste changes, subjec ve dry mouth, geographic and fissured tongue, painful teeth, headache, neck and shoulder pain, difficulty speaking, nausea, gagging and swallowing difficul es. BMS has been reported to follow dental treatment, an bio c usage and a severe upper respiratory infec on. The lack of pathology to account for the pain can be frustra ng. Pain is constant, progressively increases over the day, and usually decreases during ea ng. Pa ents, who are frequently distressed by their unremi ng symptoms, may demonstrate psychological abnormali es including anxiety and depression. Therapy for BMS involves the use of centrally ac ng medica ons for neuropathic pain, such as tricyclic an depressants, benzodiazepines or gabapen n. Clonazepam is a benzodiazepine used either topically or in low doses orally, which appears to have excellent efficacy in the relief of the symptoms related to BMS. Topical medica ons, including clonidine, may be considered for applica on to local sites. A combina on of oral medica ons for the management of BMS (clonazepam, gabapen n, baclofen, and lamotrigine) significantly decreased pain in 38 or 45 pa ents. The most common adverse effect reported with the medica on protocol was drowsiness followed by dizziness and perceived changes in mood. These results suggest that BMS may be treated with lower doses of a combina on of medica ons rather than higher doses of a single medica on, which may help to limit adverse effects such as drowsiness or dizziness. Adv Otorhinolaryngol. 2006, 63:278–287 Topical Clonazepam for Burning Mouth Syndrome Stomatodynia (burning mouth syndrome) is characterized by a spontaneous burning pain in the oral mucosa without known cause or recognized treatment. A double‐blind, randomized, mul center parallel group study evaluated the efficacy of topical use of clonazepam. Forty‐eight pa ents (4 men and 44 women, aged 65+/‐2.1 years) were included, of whom 41 completed the study. The pa ents were instructed to suck a tablet of either clonazepam 1 mg or placebo and hold their saliva near the pain sites in the mouth without swallowing for 3 min and then to spit. This protocol was repeated three mes a day for 14 days. The intensity was evaluated by a 11‐point numerical scale before the first administra on and then a er 14 days. Two weeks a er the beginning of treatment, the decrease in pain scores was 2.4+/‐0.6 and 0.6+/‐0.4 in the clonazepam and placebo group, respec vely. Pain. 2004 Mar;108(1‐2):51‐7 It is hypothesized that clonazepam acts locally to disrupt the mechanism(s) underlying stomatodynia. A formula on for a mouth rinse containing clonazepam 1 mg per 5 ml was reported in the Interna onal Journal of Pharmaceu cal Compounding (Vol. 9, No. 4, July/Aug 2005, p. 310). This prepara on is easier to use than the study protocol.


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Burning Mouth Syndrome (BMS) Relieved with Alpha Lipoic Acid (ALA) Primary burning mouth syndrome (BMS) is a chronic, idiopathic intraoral mucosal pain condi on that is not accompanied by clinical lesions or systemic disease. BMS occurs most o en among women and is o en accompanied by xerostomia and taste disturbances. Recently, a neuropathological basis has been proposed so that BMS may be regarded as an oral dysesthesia or painful neuropathy. Topical clonazepam and cogni ve therapy have been proven efficacious in some pa ents. Emerging evidence supports the effec veness of the an oxidant, alpha lipoic acid (ALA, thioc c acid). Alpha lipoic acid is able to increase the levels of intracellular glutathione and eliminate free radicals. A double blind, controlled study compared alpha lipoic acid with placebo for two months on 60 pa ents with constant BMS, in whom there was no laboratory evidence of deficiencies in iron, vitamins or thyroid func on and no hyperglycemia. Following treatment with alpha lipoic acid 600 mg orally daily, there was a significant symptoma c improvement compared with placebo. This improvement was maintained in over 70% of pa ents at the 1 year follow‐up. Another study showed that pa ents with BMS who had previously been treated with benzodiazepines responded poorly to therapy with alpha lipoic acid compared with those who had not received benzodiazepines. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Mar;103 Suppl:S39.e1‐13 J Eur Acad Dermatol Venereol. 2004 Nov;18(6):676‐8 J Oral Pathol Med. 2002 May;31(5):267‐9


We work together with den sts and their pa ents to provide customized dosage forms that meet each individual’s specific needs and solve medica on problems. Please call us if you need a specialized prepara on that is not commercially available or

to discuss formula ons to meet the needs of specific pa ents.

Topical therapies such as a mouth rinse, lozenge, or muco‐adhesive paste offer the advantage of direct applica on to the affected site and a lower incidence of side effects. Taste and flavor can be selected to please the individual, the most appropriate dose of each drug can be used, alcohol content can be limited, and dyes found in commercial products

(which may stain the oral mucosa) can be eliminated. Your ques ons are always welcome.

dental compounding - patterson park pharmacy · dental compounding we customize ... transdermal gel...

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