Consensus Conference on the "New Tecnologies in Miniscrews & Miniplates”

Gianluigi Fiorillo DDS, MSc, Moderator gianluigifiorillo@gmail.comDieter Drescher DDS, MSc, Phd. D.Drescher@uni-duesseldorf.deNelson Donald DDS, DMD. dbnjazz@gmail.comCarla Evans DDS,Msc, Phd. caevans@uic.eduFrancesco Grampone DDS, MSc. grampone@libero.it Fabio Labate DDS, MSc, Phd. fabiolabate@libero.itCesare Luzi DDS, MSc. cesare.luzi@gmail.comGiuliano Maino DDS, MSc. vicenza@mainog.com

Intoduction In recent years, the orthodontic scenario has been drastically transformed by the introduction of an innovative procedure known as skeletal anchorage and, especially, the use of miniscrews as biomechanical anchors. Not only may the latter replace all existing anchorage instruments in orthodontics, but they may also allow overcoming current limitations associated with the use of traditional tools. These include collapsing, unfavorable anatomy, discomfort, damage and complexity of implementing procedures among others. Contrarily to traditional anchorage devices, the use of miniscrews enables practitioners to create customized biomechanical designs, reducing the need of surgery. These benefits have been confirmed by the latest peer-reviewed scientific literature, including numerous case studies. However, this revolutionary procedure is not yet widely executed due to a variety of reasons. As the approach is yet to be mastered, professionals fear that the technique may be invasive, causing a number of potential complications and side effects. As a consequence, patients are rarely recommended this alternative. The following discussion is based on the results of a questionnaire designed by leading experts in the field.  The paper aims to discard all emotional bias linked to this new method and  provide clear guidelines for its correct implementation.

Gianluigi Fiorillo In which clinical task do you most frequently use miniscrews in your practice?

Dieter Drescher Molar distalization, molar mesialization, alignment of impacted teeth, molar uprighting, molar intrusion, midline correction, rapid maxillary expansion, maxillary protraction (early Cl. III treatment)

Carla Evans. I personally utilize TAD most frequently for skeletal transverse expansion, typically when the patient displays periodontal bone loss or short dental roots (e.g., Papillon-Lefevre Syndrome). Palatal expansion can be achieved without using the teeth as anchors.7

Using palatal miniscrews to anchor an expansion plate in conjunction with surgically-assisted rapid palatal expansion.

Francesco Grampone Essentially, I use it in all cases where the force on the reactive unite would generate adverse side effects. For instance, in cases of protraction or distalization of posterior teeth, uprighting of mesially tipped molars, retraction of anterior teeth into extraction spaces,intrusion of anterior incisor during gummy smiles correction, and extrusion of canine teeth.

Fabio Labate Distalization , mesialization, molar intrusion especially in multidisciplinary treatments in a part of an arch in adult patients and in cases of lack of cooperation in the use of inter-arch elastics, reduced dental anchorage available.

Cesare Luzi There are two clinical problems that make me benefit from the use of TADS routinely. The first is adults with partially edentolous ridges or periodontal problems. In these cases anchorage can be difficult to setup if posterior teeth are missing or inconvenient if teeth feature a compromised periodontium. In these cases skeletal anchorage opened new horizons to our treatments. The second problem is maximum anchorage requirements.

Whenever I know that teeth have to be moved without any possible side effect on the anchorage unit I decide to load the patient’s bone instead of his teeth.

Giuliano Maino I’m using mini screws very often in non-compliance cases regardless of the different biomechanical needs and the required tooth movements. The malocclusions that in my opinion are profiting most are Class II without extractions(18), hyperdivergent cases with open bite tendency, Class III cases with maxillary retrusion, class II cases where a tentative of mandibular growth stimulation it’s advisable, as well as adult multidisciplinary cases especially where intrusion of overerupted teeth and molar Up-righting are required.

Donald Nelson Primarily, they are useful in establishing anchorage where needed, targeting specific areas of the dentition to isolate anchorage needs [1]We now have options for treating cases where cooperation is an issue [1]TAD's can mimic the use of Class II elastics [2]They can be used in lieu of headgear for distalization though they do not provide the orthopedic factor [3]They can be substituted for protraction headgear by providing direct skeletal anchorage though again, some orthopedic benefits may be lost [4].

Gianluigi Fiorillo With the use of miniscrews how did the need for other orthodontic auxiliaries change?

Dieter Drescher Yes! With the use of TADs the headgear has become practically obsolete. 1 Using mini-plates in the mandible, extraoral devices for maxillary protraction in Cl. III are also no longer needed.2,3 Mini-implants inserted in the anterior palate can be equipped with special abutments to construct appliances for molar distalization, mesialization or intrusion.4

Carla Evans Utilization of miniscrews increases the range of malocclusions that can be managed in an orthodontic practice. Previously, treatment plans for some orthodontic problems either included an orthognathic surgery procedure or accepted a compromised result, but now may be possible with assistance of miniscrews. Also, miniscrews may be included in alternative treatment plans when a patient is not compliant with wearing headgear or other orthodontic auxiliaries. These advances, however, do not allow the orthodontist to forget the principles of biomechanics.

Francesco Grampone Using miniscrews I decreased the need for other orthodontic auxiliaries. The possibility to anchor on the bone instead of on the teeth reduces the need for extra-oral forces or the need for tools able to increase dental anchorage. I don’t use auxiliaries to distalize teeth anymore.

Fabio Labate The use of headgears is almost eliminated.

Cesare Luzi The use of miniscrews can greatly diminish the need of traditional anchorage auxiliaries such as transpalatal arches, lower lingual arches, head-gears, stainless steel sectional archwires, etc. This on one side simplifies the orthodontist’s job making anchorage more secure by loading the patient’s bone and not his teeth, avoiding detrimental side effects, and on the other side reduces the overall “load” of the appliance making it more confortable and acceptable for the patient.

Giuliano Maiono In my office, the use use of extraoral forces (cervical traction, high pull traction) and class II elastics have been substantially reduced.

Donald Nelson At present, we have implemented miniscrews in the following clinical scenarios: To create anchorage where needed for selected movements of distalization, mesialization and lateral shifts. In addition, for support of SARPE in adults with compromised buccal cortical bone support.

Gianluigi Fiorillo What are the ideal characteristics of a miniscrew (diameter, length, etc.)?

Dieter Drescher made of titanium alloy (Grade V), sufficient diameter, i.e. >= 1,6mm20, sufficient length, i.e. >= 7mm, self drilling thread, tapered or conic intra-osseous part, smooth neck, versatile head.

Carla Evans In vivo studies in the literature have been confusing and contradictory. However, finite element and laboratory studies have given us some clues about design of anchor devices.1,2,5 Our 2012 paper in the Angle Orthodontist showed that some factors affected the stresses in bone (implant diameter, implant head length, thread size, and elastic modulus of cancellous bone), while other factors did not (intrabony implant length, thread shape, thread pitch, and cortical bone thickness). Factors that affect stress levels are likely to affect long-term stability.

Francesco Grampone Some authors show that screws of 8 mm in length and at least 1.2 mm in diameter have sufficient stability with a minimum risk of root damage. No risk difference was found for self-tapping or self-drilling screws. When needed, particular care needs to be taken with the pilot hole because its preparation could increase risk of failure. For this reason and to avoid any surgical-related factors I prefer screws with self-drilling extremity. I also recommend screws without trans-mucosal plate because it has been showed that in cases of over-angulated insertion, useful to primary stability, the plate may produce an ischemic gingiva on one side and an area of easy bacterial access on the other side, increasing the risk of failure. The head design is important because it should guarantee a full use, from a direct anchorage to an indirect anchorage.

Fabio Labate Monocortical, self-cutting, self-drilling, 8 x 1,7mm, bracket shaped head, crossed slot 0.22.

Cesare Luzi Last generation miniscrews have some common important characteristics. Overall length should be at least 9mm and not exceed 13mm, thread length should not be less than 6mm to reduce the risk of loss of stability (6), neck lenghts should be in relationship to the thickness of the soft-tissues (1-3mm). The diameter should not be inferior to 1.2mm to avoid risk of fracture (4) and not exceed 1.6mm in order to be useful in inter-radicular sites. The point should have self-drilling characteristics and the thread cut should be asymmetric and deep enough to increase stability preventing pullout (7).

Giuliano Maiono The ideal miniscerw should have the shortest length and the thinner diameter with respect to the insertion site and the quality of bone available. However both factors could vary depending from patient to patient. A greater increase in the diameter appears to be linked to a higher amount of success(7). According to other studies, the length of the implant is not very important to the success of a miniscerw(1)(8). In contrast (9)other studies report that, using thin miniscrew , increasing the length will correspond to a greater success rate(10)(11). Length and diameter of the miniscrew therefore should be chosen according to the ammount of available bone, to the bone quality and specific anatomival condition. Many studies have been carried out to compare the shape of the infrabony portion of the mini screws. Some studies claim that the conical shape ensures greater primary stability and this should translate into a greater amount of success (12) (13) (14).On the other hand, when comparing the clinical success rate between conical and cilindrical miniscrews, no difference has been found (15).

Donald Nelson Orthodontic miniscrews should be comprised of a titanium alloy without surface treatment, as this would encourage osseointegration of the miniscrew [6].

It has been recommended that screw sizes less than 1.2 mm in diameter and 8mm in length should be avoided [17, 18]. Gianluigi Fiorillo How much does the operator’s experience weigh on preventing the risk of failure? How to prevent failure?

Dieter Drescher There are several ways to minimize failure rates of mini-implants:7-20Insert mini-implant through the attached gingival or mucosa (oblique insertion), avoid root contact,

avoid excessive insertion torque, i.e. > 40 Ncm, assure sufficient insertion torque, i.e. > 5 Ncm, avoid mini-implants with too small diameter, i.e. >= 1.6 mm, in the maxilla: prefer the anterior palate, avoid the alveolar ridge, in the mandible: avoid the front segment of the dental arch, instruct the patient how to provide sufficient oral hygiene, monitor oral hygiene, avoid axial moments as well as too large tipping moments, use two coupled implants (tandem).

Carla Evans We studied factors associated with initial stability of miniscrews.4 Site of insertion and experience of the clinician were the only significant variables. The midpalatal area was the most suitable for initial stability. Clinicians who performed more than 20 miniscrew insertions had a higher success rate than those with less than or equal to 20 insertions, even after adjusting for insertion site. The potential confounding patient and device variables examined were gender, age, jaw, insertion site, tissue type, length and diameter of the miniscrew, and number of previous insertions. Though not studied in our research, it is possible that long- term stability may be related to quality of bone and other factors.

Francesco Grampone With screws as well as any other tool, clinical experience reduces the incidence of failures. In particular, learning curve influences surgery-related factors such as flap procedures, hole preparation, and jiggling placement procedures. In order to avoid failure, it’s also important to follow the the orthodontics-related guidelines, for instance by preferring immediate load to delayed load or by using force levels up to 200 g avoiding unscrewing movements.

Fabio Labate The operator’s experience has a little impact on the prevention of failure if the procedures are being followed and the patient is appropriately informed once the insertion site is properly detected.

Cesare Luzi Miniscrews fail due to problems related to the patient or problems related to the clinician (1). Patient-related factors involve mainly bone quality, oral hygiene, soft-tissues characteristics and other minor factors. The main clinician-related problem is an incorrect insertion procedure. Experience plays a very important role in the overall failure rates as lack of primary stability due to an incorrect insertion procedure or an unfavorable insertion site (lack of proper distance fron the adjacent roots or poor bone quality) is a common problem.

A learning curve is required to prevent failure as much as possible, although 100% success in never possible and does not appear in the literature (2).

Giuliano Maiono According to many studies, there is a learning curve in the miniscerw insertion that will affect the percentage of success and failure. To prevent failures, the clinician should provide a good radiographic survey prior to the application of a miniscrew. If the miniscrew is inserted in the interproximal spaces, I suggest to use a periapical x ray performed with the parallel technique to avoid bias and to have reliable measurements. Panoramic X ray can be used in presence of wide spaces due to the enlargement of this type of examination. Another option is the use of a CBCT scan. It is also advisable the use of a surgical guide83)(4) especially if the the miniscrew insertion will be performed in difficult areas and narrow spaces, and if the experience of the operator is limited.

Donald Nelson Failure and success rates are highly correlated to the clinical skill and experience of the operator who places the miniscrew. Achieving primary stability appears to be the most important determinant for the success of the miniscrew. Insufficient primary stability will lead to deficient healing and the premature loss of the miniscrew [13]. In regards to insertion procedure, the initial force of placement should be performed with moderate force and once the initial threads have penetrated the cortical bone, allow the miniscrew to draw itself in [14]. Wiggling/wobbling action of the miniscrew while inserting should also be avoided.

Gianluigi Fiorillo Which failure factors are patient-dependant and cannot be prevented?

Dieter Drescher Poor oral hygiene21 Manipulation by patient.

Carla Evans I wouldn’t put miniscrews in patients who are moderate-to-heavy smokers, have poor oral hygiene, or have increased susceptibility to infection. Also, it is possible that a patient’s physician may determine that placement of miniscrews is contraindicated due to certain medical or psychological conditions. All orthodontic treatment for patients with significant medical or psychological disorders should be undertaken only after consulting with the patient’s physician(s).

Francesco Grampone Patient-dependent factors such as those realted to the quality and quantity of cortical bone and the quality and quantity of keratinized gingiva cannot be prevented. Preventable but unfavorable factors are smoking, use of bisphosphonates, and poor oral hygiene.

Fabio Labate Hygiene, traumatic nutrition, bone metabolism.

Cesare Luzi The main patient-dependant failure factor is poor bone quality. Proper cortical bone thickness should exceed 1mm (3) in order to reduce risk of loss of stability. Posterior areas, especially in the mandible, meet this criteria. Anterior areas are more at risk, and also high-angle patients (4). A second factor that influences negatively failure is the presence of thick soft-tissues (5), like in the palatal sites or the lower retro-molar area. Keratinized attached soft tissues should always be preferred when possible. A third negative factor is poor oral hygiene, promoting inflammation of the tissues surrounding the screw head and neck. Proper attention to oral hygiene daily procedures should be well discussed and the patient should be properly instructed.

Giuliano Maiono The bone quality is not clearly predictable expecially in growing patients where we could face a wide range of bone density. It’s well known that the bone quality will affect the miniscrew stability(6) and in presence of a soft kind of bone we could expect more failures.

Donald Nelson The following are patient-dependent influencing the success or failure of miniscrews [15]:Plaque and gingivitis indices, oral hygiene, smoking, metabolic disorders such as diabetes or osteopoenia which influences bone density [16]

Gianluigi Fiorillo How to prevent root damage?

Dieter Drescher The best way is to avoid insertion of mini-implants into the alveolar ridge, which is easily possible in the maxilla.4 In the mandible use of mini-plates instead of mini-implants has to be considered.22If mini-implants are to be inserted into the alveolar ridge, a panoramic X-ray of good quality is obligatory. A distance of at least 1mm between the implant and the adjacent roots is recommended.10

Carla Evans Experienced clinicians examine closely the pre-treatment records. They then determine an adequate angle of insertion (i.e. generally oblique at 20-40 degrees) and then maintain that angle during screw insertion.

Francesco Grampone Clinical examination and appropriate analysis of the plaster casts as well as of theradiographs can prevent any root damage. In particular, 3D-based radiographic analysis is the best solution. However, if it’s unavailable, panoramic x-ray and periapical radiographs are adequate to evaluate the root positions. Eventually, to avoid roots, I take a periapical radiograph during surgery. An additioinal sign of being too close to the root may come the patient complaining of intra-procedural pain. Using a superficial anesthesia the patient will feel pressure, but not pain, unless the screw contacts the periodontal ligament or the tooth root. In this case, it is useful to change the angle of insertion angle or eventually the insertion site.

Fabio Labate Radiographic evaluation of the site after doing the dental allignment or use of passive wires on the teeth adjacent to the miniscrews, mucose topical anesthesia, manual tightening.

Cesare Luzi Root damage is a possible complication if the insertion procedure is not planned correctly. It is an unlikely event to generate permanent damage as healing of the periodontium following contact or approximation of the miniscrew with the roots followed by screw removal has been extensively demonstrated (8). The most important phase is the selection of the insertion site following clinical and periapical radiographs parameters. A minimum of 4mm clearance between the roots is necessary to reduce risks. During insertion attention should be payed to possible increases of resistance during the procedure which could be an indicator of root contact. Post-insertion periapical radiographs should always be taken. In case of doubt and in presence of pain following the anestesia effect, the miniscrew should be removed and replaced.

Giuliano Maino A thorough X Ray investigation, meticulous clinical evaluation, small amount of anesthetic, the use of a surgical guide and a proper clinical training are the main factor to avoid root damage when inserting miniscrews. It could be usefull remember that, in the case of root contact with the miniscrew, the root surface will repair similary to the resorption areas that may be ecountered during a regular orthodontic treatment(16)(17).

Donald Nelson To prevent root damage, the clinician should be fully aware of the interradicular space for the intended miniscrew placement. The area should be radiographically assessed before proceeding. The miniscrew size should be selected as to placed at least 1mm away from adjacent roots [18]

Gianluigi Fiorillo Did 3D diagnostics change planning procedures for miniscrew insertion?

Dieter Drescher CBCT can be used for planning mini-implant insertion23, but given the radiation exposure is it questionable if it is really justified.

Carla Evans We recently published guidelines for use of CBCT in orthodontic treatment.6

We cited numerous authors who identified CBCT imaging as being clinically useful in identifying optimal site placement of orthodontic miniscrews. Clinicians are instructed to: “1. Image appropriately according to clinical condition, 2. Assess the radiation dose risk, 3. Minimize patient radiation exposure, and 4. Maintain professional competency in performing and interpreting CBCT studies.”

Francesco Grampone 3D didn’t change planning procedures but increased it success rate because at radiation exposure very similar to that of panoramic you can have greater and more precise informations. In fact, with CBCT you can evaluate position, distance, root divergence and bone thickness in all the planes of the space. Unfortunately, it is not always possible to use this tool because of its associated costs.

Fabio Labate The assessment of cortical thickness surely affects significantly the choice of the site of insertion of miniscrews, but if the CBCT is performed only for this I think is an overtreatment.

Cesare Luzi 3D diagnostics changed the way we look at our patients in many situations. Planning miniscrew insertion is not one of them. In my opinion the request of a 3D scan is not justified, due to radiation dose and costs for the patient, unless there are doubts on the anatomy that 2D traditional radiographs cannot make clear. A standard protocol requires only the use of parallel periapical films.

Giuliano Maino The use of 3D X Ray investigation makes easier the case analysis and in some specific situation also the planning of the miniscerw insertion especially in areas difficult to investigate with conventional (2D) radiologic techniques such as the palatal vaulte

and the mandibular region in correspondence with the oblique line(4).

Donald Nelson Cone beam computed tomography (CBCT) could serve as a useful adjunct that could identify more precisely the proximity of vital areas such as the maxillary sinus and major nerves. In addition, the interradicular bone mass could be made. Surgical stents can also be fabricated from the imaging [19].

Gianluigi Fiorillo Is it necessary to perform local or systemic antibiotic?

Dieter Drescher Systemic antibiotic prophylaxis can be useful when inserting mini-plates. For the insertion of mini-implants administration of systemic antibiotics is not needed.In the case of mild peri-implant inflammation or mucosal hyperplasia local CHX application can be recommended.

Carla Evans When the health history reveals cardiovascular disease or other disorders that might predispose a patient to infective endocarditis, or when a patient reports a total joint replacement, it’s important to contact the patient’s physician and determine together whether antibiotic prophylaxis is needed. We follow the American Dental Association and the American Heart Association guidelines.

Francesco Grampone Prescription of antibiotics is not recommended unless there are specific medicalindications.However, local prophylaxis is needed with the surgical protocol. Good oral hygiene is the most important factor. Chlorexidine mouthrinses (0,20%) for 30 seconds before surgery allows for reduction of local antimicrobial activity.

Fabio Labate No, local disinfection is sufficient.

Cesare Luzi There is absolutely no need for antibiotic prophylaxis. The last generation self-drilling/self-tapping miniscrews require a minimally invasive trans-mucosal insertion procedure. There is never the need to perform flap surgery, bleeding is absent or extremely limited and the bur (rotating instrument) is used only in sites with thick cortex (i.e. lower retro-molar region). Pain-killers could be suggetsed, although the need is patient-dependant, while chlorexidine mouthwash is recommended for one week post-insertion during the healing of the soft-tissues.

Giuliano Maino No, it’s not necessary. I do it only in patients where needed for general conditions.

Donald Nelson Local antibiotic applied to the implant site is recommended. With mini-screws patients are asked to apply chlorhexedine with a cotton swab daily to tissue around the screw head [6] [7]. With mini-plates, the oral surgeon will generally prescribe systemic antibiotics following the procedure, however it is questionable that it is absolutely necessary [8]

Gianluigi Fiorillo What kind of anesthesia is recommended?

Dieter Drescher Local and optionally topic anaesthesia is sufficient for mini-implant insertion.5 Removal of mini-implants usually needs no anaesthesia.6

Carla Evans Traditional local infiltration methods are effective for miniscrew placement both in the alveolar process and the palate. We studied two topical anesthetics for placement in the maxillalry and mandibular alveolar processes, Oraqix and TAC alternative3. Oraqix, an FDA-approved topical anesthetic gel for scaling, root planing (SRP) and gingival curettage contains 2.5% lidocaine and 2.5% prilocaine. TAC(a) is a compound mixture of 20% lidocaine, 4% tetracaine, and 2% phenylephrine. Based on the dosage, onset time, the patients’ responses on pain scales, and observation of their subjects’ SEM (sound, eye, motor) movements, we concluded that TAC(a) is a more effective topical anesthetic during

the placement of TADs than Oraqix. We recommended that 0.20–0.30 mL of TAC(a) be applied for a minimum of 3 minutes. Patients should always be queried whether they have had an adverse reaction to anesthetics.

Francesco Grampone In accordance to the current literature I don’t use deep anesthesia. I deliver the anesthetic only to surrounding soft and periosteal tissue. In this way, when the screws are applied, patients will only experience some pressure. Pain may occur if the screw contacts the periodontal ligament or the tooth roots. Thus, the insurgence of pain represents an important sign for the clinician to avoid root damage. I use topic anesthetic gel or local anesthetic spry before the local infiltration of Lidocaine.

Fabio Labate Mucose topicalanesthesia.

Cesare Luzi The ideal would be to give to the patient the minimal possible quantity of anesthesia in order to affect the soft tissues and the periosteum, with minimal effect on the deep tissues (PDL and teeth). This way the patient would feel pain if the tip of the miniscrew would reach proximity to the PDL and tooth. Local anesthesia is always recommended with an infiltarative technique, both in the maxilla and in the mandible. Topical spray anesthesia is the alternative, but might not be always effective to avoid patient pain during insertion.

Giuliano Maino We could use gel with high percentage of anesthetic (Lidocain 30%) in areas with thin soft tissues. I prefer tissue infiltration with a minimum amount of anesthetic . I’m using Lidocain with adrenalin 1:100.000. It’s important to use a little amount of anesthetic in order to leave intact the dental sensitivity.

Donald Nelson In many cases, a potent pharmacy prepared topical is sufficient. Our current formulation used is as follows: 10% Lidocaine, Prolocaine 10%, Tetracaine 4% and Epinephrine 2% [5].

Gianluigi Fiorillo Are there any problems with the use of miniscrews in growing patients?

Dieter Drescher The failure rate seems to be slightly higher in growing patients.24

Carla Evans Miniscrews may be contraindicated in growing patients with unerupted teeth because there may be insufficient space for the miniscrew.

Francesco Grampone Studies show a lower success rate with adolescents because of insufficient bone density. They also suggest to avoid the use of screws in patients under 11 years of age. However, I have successfully treated teenagers with miniscrews in the palatal area without failure. In growing patients, take care during screw insertion to avoid positioning the screws in areas of permanent tooth development.

Unfortunately, I have no experience with the use of miniscrews with orthopedic force.

Fabio Labate Certainly those related to the buds of not erupted permanent teeth, the decrease of cortical thickness and at the lesser compliance (hygiene, nutrition).

Cesare Luzi TADS are orthodontic tools that by definition are “temporary” and are generally removed after some months of use as soon as the orthodontist changes treatment phase. The orthodontic load generates continuous tissue remodelling around the screw (9) and the smooth untreated surface makes removal generally very simple. The use of TADS in growing patients is absolutely not a problem. The only risk is leaving a miniscrew in place several months without loading it, promoting osseointegration. In this case removal could be more problematic (10).

Giuliano Maino Right now there is no study advising against the use of miniscrews in

growing patients.

Donald Nelson Currently, there is equivocal data on the use of miniscrews in growing patients. It has been previously reported that higher failure rates occurred in growing patients attributed to lesser bone densities’ and cortical thickness [20]. However, in regards to orthopaedic traction in growing patients, some success has been reported in growing skeletal class II and Class III growing patients [21] [22]

Gianluigi Fiorillo Who should insert miniscrews, the orthodontist or the surgeon?

Dieter Drescher Preferably the orthodontist (personal opinion)..

Carla Evans Insertion of miniscrews in the alveolar process and palate falls within the scope of orthodontic practice. In those situations, the orthodontist is best able to judge the optimal placement for executation of the planned mechanics. An orthodontist who prefers to refer the placement of TADs in the alveolar process or palate could refer either to a periodontist or oral surgeon. Temporary anchor devices placed in the mandibular ramus or zygomatic arch should be handled by an oral surgeon.

Francesco Grampone I place my own miniscrews and I personally think orthodontists are recommended to do it because othodontists know exactly where the screws should be placed. Moreover, if more than one dentist is involved with the procedure and the treatment fails, it could be difficult to find out who is responsible for the failure.

Fabio Labate The orthodontist, if the insertion doesn’t require flap (if it’s a flap-less insertion).

Cesare Luzi The orthodontist is the best candidate for miniscrew insertion. The procedure is a very simple flapless surgery that does not require particular surgical skills. The orthodontist knows exactly the use he has planned for the miniscrew, the details of the treatment plan, the programmed biomechanics and the final position of the teeth which is planned at treatment start. He will therefore choose the best available insertion site consistent with the following upcoming tooth movements. Miniscrews should be considered tools for orthodontists, not forsurgeons.

Giuliano Maino It’s largely accepted that miniscrews should be applied directly by the orthodontist. In fact the site of miniscrew insertion is selected not only on the basis of anatomic space availability but it’s also dictated from the biomechanics needs. Further more, doing like this, the miniscrew insertion become simple for the pazient also in terms of time saving.

Donald Nelson Either, but if the mini-screw is placed by the oral surgeon, the site should be carefully targeted by the orthodontist to facilitate optimal mechanics [9]

Gianluigi Fiorillo Which is the best way to propose to the patient the use of miniscrews?

Dieter Drescher Explain to the patient, why skeletal anchorage is useful. Extraoral traction can be avoided.

Carla Evans After developing specific treatment objectives based on high quality records and known effectiveness of different treatment modalities, I would explain my preferred treatment plan to the patient. I would state that treatment plans utilizing miniscrews have been shown to be safe and predictable. If the patient requires more information, I wouldn’t hesitate to supply relevant published articles. I also encourage patients to see second opinions.

Francesco Grampone The best way to propose the use of the miniscrews to the patient is to believe in it. Too many are the advantages of using miniscrews .The possibility to reduce treatment time and avoid anchorage on the natural dentition is the most effective argument to convince our patients.

Fabio Labate Proposing if possible an alternative with the use of other auxiliaries the obtainable result without their use, emphasizing the longer duration of the therapy and greater need of cooperation.

Cesare Luzi Personally, when speaking to patients and parents, I refer to miniscrews as orthodontic temporary gingival “piercings” or small gingival “pins” used to control possible side-effects of the treatment mechanics. I never use the word “screw” or “implant” which tend to make the patient think of invasive surgical procedures. Furthermore, I stress the fact that TADS are new generation devices made on purpose for orthodontists and are becoming daily tools. This simple language helped me very much to comunicate to patients and parents the benefits of TADS without generating refusals or fear of the tool.

Giuliano Maino I suggest to carefully explain to the patient what kind of benefits he can expect from a non-compliance treatment, including avoidance of the use of extra-oral devices, Class II elastics a. Then underline the greater predictability of outcome with respect to a treatment where collaboration is uncertain or is in missed. Finally i twill be explained to the patient that inserting a temporary anchorage miniscrews is a minimally invasive procedure and much less unconfortable in comparision to an extraction of a premolar i.e. In 50% of cases it does’ n cause any pain at a distance of one hour. In 90% of cases there will be no pain the day after(1). Everithihng can be controlled with a simple analgesic.

Donald Nelson Patient education is fundamental for a patient’s acceptance to the use of miniscrew placement. The following is recommended to be included in the dialogue with the patient:The use of the miniscrews may permit for orthodontic movements to occur which otherwise could not be obtained therefore allowing the orthodontist to obtain a more ideal treatment result for the patient.The miniscrew, which is very discreet, painless and easy to insert would eliminate the need for more bulky and cumbersome hardware.Always show the patients the anchorage options (nance, headgear, etc.) and allow them to decide between the miniscrew or the alternatives.Allay any fears or anxiety to the procedure the patient may have as the patient’s acceptance is strongly influenced by pain and discomfort [12].

Gianluigi Fiorillo Which specific characteristics does the Informed Consent format require?

Dieter Drescher Depends on local legislation. In Germany the most common possible side effects have to be mentioned: inflammation, mplant loss, root contact, if TADs are inserted into the alveolar ridges.

Carla Evans The American Association of Orthodontists8 has two consent documents for TADs; they are found on the AAO Insurance Company website (www.aaoic.com). One is contained within the general consent for orthodontic treatment. The other is a separate supplemental form that gives similar information and, in addition, requires the patient to disclose tobacco use. I agree with the content of both and feel strongly that the patient must be informed of the risks. The AAO’s general consent form states: “Your treatment may include the use of a temporary anchorage device(s) (i.e. metal screw or plate attached to the bone.) There are specific risks associated with them. It is possible that the screw(s) could become loose which would require its/their removal and possibly relocation or replacement with a larger screw. The screw and related material may be accidentally swallowed. If the device cannot be stabilized for an adequate length of time, an alternate treatment plan may be necessary. It is possible that the tissue around the device could become inflamed or infected, or the soft tissue could grow over the device, which could also require its removal,

surgical excision of the tissue and/or the use of antibiotics or antimicrobial rinses. It is possible that the screws could break (i.e. upon insertion or removal.) If this occurs, the broken piece may be left in your mouth or may be surgically removed. This may require referral to another dental specialist.When inserting the device(s), it is possible to damage the root of a tooth, a nerve, or to perforate the maxillary sinus. Usually these problems are not significant; however, additional dental or medical treatment may be necessary. Local anesthetic may be used when these devices are inserted or removed, which also has risks. Please advise the doctor placing the device if you have had any difficulties with dental anesthetics in the past. If any of the complications mentioned above do occur, a referral may be necessary to your family dentist or another dental or medical specialist for further treatment. Fees for these services are not included in the cost for orthodontic treatment.”

Francesco Grampone The informed consent has to specify that insertion and dis-insertion involves a minimally invasive surgical approach and need for post-operative care. The patient has to be informed about the possibility of failure or fracture. Furthermore, in the event that a screw fracture occurs, the patient needs to consent about the need to follow the dentist judgment on whether the screw will have to be removed or left in place.

Fabio Labate The Informed Consent must be detailed and understandable/clear as with any other procedure.

Cesare Luzi The Informed Consent should explain clearly what is a Temporary Anchorage Device, the reasons and the advantages of the use of TADS and the possible risks associated to the procedures. It should be clearly stated that TADS are orthodontic anchorage tools and have nothing to do with traditional implants and with the risks associated to the use of these last devices.

Giuliano Maino It should contain a clear explanation that the miniscrew is a temporary anchorage device perfectly biocompatible and that its insertion requires the use of a minimum amount of anesthetic. It should also be specified that the miniscrew sometimes can become mobile and in those cases must be repositioned. It should be emphasized the need for careful hygiene worth the failure of the implant. Among the possible complications we must mention the rare possibility that it could be experienced a fracture of the mini implant. In that case, accoding to the clinical needs, the miniscrew can be removed or left in place.

Donald Nelson The standard informed consent released from the American Association of Orthodontists (AAO) includes the following possible complications [10]: Loosening of the miniscrews that would require their removal subsequent replacement/relocation.Accidental swallowing of screw and related material. Inflammation or infection of surrounding tissue leading to soft tissue overgrowth which would be managed surgically or palliatively with antibiotics. Breakage of screws that may require referral to another dental specialists. Damage to adjacent root, nerve or perforation of maxillary sinus which may necessitate additional dental/medical treatment. Associated risks from the local anesthetic used to increase patient comfort while inserting miniscrews. In addition, it may be noted that the goals of the mini-screw may not be met.

Gianluigi Fiorillo Is traditional insurance policy for orthodontist covering the risks of miniscrew usage?

Dieter Drescher In Germany: the insurance policy has to be updated, which was no problem in my case.

Carla Evans Insertion and utilization of miniscrews falls within the realm of orthodontic practice and insurance coverage from The American Association of Orthodontists Insurance Company includes miniscrew usage. Other dental insurance companies may compute the cost of their plans based on the degree of clinical intervention and the degree of anticipated

risk. Orthodontists who plan to utilize TADs and lasers should read the insurance policies carefully before purchasing insurance.

Francesco Grampone In contrast to implant surgery, the use of miniscrews does not need specific insurance coverage because it’s evident that the characteristics of the screws are different from those of the osteointegrated implants. Further, the surgical risk is different during implant insertion and screw failure cannot be considered like implant failure.Moreover, if our insurance covers the root damage that could result from the orthodontic over-forces, why wouldn’t it cover for the risks associated to the use of

miniscrews?

Fabio Labate The traditional insurance policy “without implants” is enough especially if miniscrews are considered as orthodontic auxiliary.

Cesare Luzi The traditional insurance coverage for orthodontists, which does not include the risks of implant surgery, has to mention clearly by the addition of an appendix that TADS, orthodontic Temporary Anchorage Devices, and the possible risks associated with their use, are included in the insurance agreement. This should not determine an increase in the insurance yearly fee as no traditional implant procedure for rehabilittion purposes should be mentioned or included in the agreement.

Giuliano Maino It seems that this type of limited insurance is not enough. It’ advisable therefore to extend the insurance policy to the use of miniscerws that be defined as mini implants.

Donald Nelson According to American Association of Orthodontists insurance company (AAOIC), the placement of miniscrews is not considered a surgical procedure and therefore provides coverage for the risks involved in their usage [11]. However, it should be noted that since the AAOIC does not provide coverage for surgical procedures, miniplates insertion that would require a surgical flap would not be covered under their policy.

References Suggest by Evans Carla

1. Lee ES, Evans CA, de Rijk WG. A finite element analysis of an HA-coated titanium onplant on bone. In: Dental Materials Group, IADR, SP Schaffer, ed., IVOCLAR North America Inc., Amherst NY, 1997.

2. Hassan AH, Evans CA, Zaki AM, George A. The use of bone morphogenetic protein-2 and dentin matrix protein-1 to enhance the osteointegration of the onplant system. Calcified Tissue Research 44:200-210, 2003.

3. Kwong TS, Kusnoto B, Viana G, Evans CA, Watanabe K. The effectiveness of Oraqix® versus TAC(a) for placement of orthodontic temporary anchorage devices. Angle Orthod 81:754-9, 2011.

4. Lim H-J, Choi Y-J, Evans CA, Hwang H-S. Predictors of initial stability for orthodontic miniscrew implants. Eur J Orthod 33:528-32, 2011.

5. Duaibis R, Kusnoto B, Natarajan R, Zhao L, Evans C. Factors affecting stresses in cortical bone around miniscrew implants. Angle Orthod 82:875-880, 2012.

6. American Academy of Oral and Maxillofacial Radiology – Panel (Evans CA, Co-Chair). Clinical Recommendations Regarding Use of Cone Beam Computed Tomography (CBCT) in Orthodontics. Position Statement by the American Academy of Oral and Maxillofacial Radiology. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 116:238-257, 2013.

7. Vanarsdall RL, Blasi I, Evans M, Kocian P. Rapid maxillary expansion with skeletal anchorage vs bonded tooth/tissue born expanders: a case report comparison utilizing CBCT. Clinical Review (RMO), April 2012, pp. 17-22.

8. American Association of Orthodontists Insurance Company (www.aaoic.com). AAO Informed Consent documents.

References suggest by Grampone Francesco

1. Kanomi R. Mini-implant for orthodontic anchorage. J Clin Orthod 1997; 31: 763-7

2. Costa A., Raffaini M., and Melsen B.. Miniscrews as orthodontic anchorage: A preliminary report, Int. J. Adult Orthod. Orthog. Surg. 1998; 13: 201-209.

3. Cope J. Temporary anchorage devices in orthodontics: a paradigm shift. Semin Orthod 2005; 11: 3-9.

4. Labanauskaite B, Jankauskas G, Vasiliauskas A, Haffar N. Implants for orthodontic anchorage. Meta-analysis. Stomatologija 2005;7:128-32.

5. Carano et co. Mechanical proprieties of three different commercially avaible miniscrews for skeletal anchorage. Progress ortho 2005; 6 (1): 82- 97

6. Chen CH, Chang CS, Hsieh CH, Tseng YC, Shen YS, Huang IY, et al. The use of microimplants in orthodontic anchorage. J Oral Maxillofac Surg 2006; 64:1209-13.

7. Mah J, Bergstrand F. Temporary anchorage devices: a status report. J Clin Orthod 2005; 39 (30) : 132-6.

8. Dalstra M, Cattaneo PM, Melsen B. Load transfer of miniscrews for orthodontic anchorage. Orthod 2004; 1 (31): 53-62.

9. Lim JW, Kim WS, Kim IK, Son CY, Byun HI. Three dimensional finite element method for stress distribution on the length and diameter of orthodontic inistre and cortical bone thickness. Kor J Orthod 2003; 33:11- 20

10. Melsen B., Costa A.. Immediate loading of implants used for orthodontic anchorage. Clin Orthod Res 2000; 3(1): 23-28

11. Cope J., Herman R., Miniscrew Implants: IMTEC Mini Ortho Implants. Semin Orthod 2005; 11: 32-39

12. Reynders, Ronchi, and Bipat. Mini-implants in orthodontics: A systematic review of the literature. American Journal of Orthodontics and Dentofacial Orthopedics May 2009; 564-68

13. Costa A., Maric M., Danesino P.. Comparison between two orthodontic skeletal anchorage devices: osseointegrated implants and miniscrews – Medical-Legal Considerations. Progress in Orthodontic 2006; 7(1): 24-31

14. Papadopoulos M.A., Tarawneh F.. The use of miniscrew implants for temporary skeletal anchorage in orthodontics: a comprehensive review. Oral Surg. Oral Med Oral Pathol Pral Radiol Endod 2007; 103 (5): 6-15.

15. Crismani A., Berti M., Celar A., Bantleon H.P., Burstone C.. Miniscrews in orthodontic treatment: review and analysis of published clinical trials. Am J Orthod Dentofacial Orthop 2010; 103 : 108-11.

References suggest by Luzi Cesare

1. Luzi C, Verna C, Melsen B. Guidelines for success in placement of orthodontic mini-implants. J Clin Orthod. 2009 Jan;43(1):39-44.

2. Schätzle M, Männchen R, Zwahlen M, Lang NP. Survival and failure rates of orthodontic temporary anchorage devices: a systematic review. Clin Oral Implants Res 2009;20:1351-9

3. Cattaneo PM, Dalstra M, Melsen B. Analysis of stress and strain around orthodontically loaded implants: an animal study. Int J Oral Maxillofac Implants. 2007 Mar-Apr;22(2):213-25.

4. Miyawaki S, Koyama I, Inoue M, Mishima K, Sugahara T, Takano-Yamamoto T. Factors associated with the stability of titanium screws placed in the posterior region for orthodontic anchorage. Am J Orthod Dentofacial Orthop. 2003 Oct;124(4):373-8.

5. Luzi C, Verna C, Melsen B. A prospective clinical investigation of the failure rate of immediately loaded mini-implants used for orthodontic anchorage.

Prog Orthod. 2007;8(1):192-201.

6. Mortensen MG, Buschang PH, Oliver DR, Kyung HM, Behrents RG.

Stability of immediately loaded 3- and 6-mm miniscrew implants in beagle dogs--a pilot study. Am J Orthod Dentofacial Orthop. 2009 Aug;136(2):251-9.

7. Migliorati M, Benedicenti S, Signori A, Drago S, Cirillo P, Barberis F, Silvestrini Biavati A. Thread shape factor: evaluation of three different orthodontic miniscrews stability. Eur J Orthod. 2013 Jun;35(3):401-5.

8. Kim H, Kim TW. Histologic evaluation of root-surface healing after root contact or approximation during placement of mini-implants. Am J Orthod Dentofacial Orthop. 2011 Jun;139(6):752-60.

9. Luzi C, Verna C, Melsen B. Immediate loading of orthodontic mini-implants: a histomorphometric evaluation of tissue reaction. Eur J Orthod. 2009

10.Suzuki EY, Suzuki B. Placement and removal torque values of orthodontic miniscrew implants. Am J Orthod Dentofacial Orthop. 2011 May;139(5):669-78.

Reference suggest by Giuliano Maiono

1. Clinical use of miniscrew implants as orthodontic anchorage: Success rates and postoperative disconfort. Kuroda S., Sugawara Y., Deguchi T., Kyung HM., Takano-Yamamoto T. Am. J. Orthod. Dentofacial. Orthop. 2007; 131:9-15

2. Predictors of initial stability of orthodontic miniscrew implants.Lim HJ, Choi YJ, Evans CA, Hwang HS. Eur J Orthod. 2011 Oct;33(5):528-32

3. The spider screw for skeletal anchorage. Maino BG, Bednar J, Pagin P, Mura P. J Clin Orthod. 2003 Feb;37(2):90-7.

4. Orthodontic miniscrew failure rate and root proximity, insertion angle, bone contact length, and bone density.Watanabe H, Deguchi T, Hasegawa M, Ito M, Kim S, Takano-Yamamoto T. Orthod Craniofac Res. 2013 Feb;16(1):44-55.

5. Correlation between miniscrew stability and bone mineraldensity in orthodontic patients.Santiago RC, de Paula FO, Fraga MR, Picorelli Assis NM, Vitral RW. Am J Orthod Dentofacial Orthop. 2009 Aug;136(2):243-50

6. Osseous adaptation to continuous loading of rigid endosseous implants. Roberts WE, Smith RK, Zilberman Y, Mozsary PG, Smith RS. Am J Orthod. 1984 Aug;86(2):95-111.

7. Factors associated with the stability of titanium screws placed in the posterior region for orthodontic anchorage.Miyawaki S, Koyama I, Inoue M, Mishima K, Sugahara T, Takano-Yamamoti T.Am J Orthod Dentofacial Orthop. 2003; 124:373-378.

8. Park HS, Jeong SH, Kwon OW.Factors affecting the clinical success of screw

implants used as orthodontic anchorage. Am J Orthod Dentofacial Orthop. 2006; 130:18-25

9. Clinical factors correlated with the success rate of miniscrews in orthodontic treatment. Topouzelis N, Tsaousoglou P.Int J Oral Sci. 2012 Mar;4(1):38-44.

10. The use of microimplants in orthodontic anchorageChen CH, Chang CS, Hsieh CH, Tseng YC, Shen YS, Hang IY, Yang CF, Chen CM. J Oral Maxillofac Surg 2006; 64 (8): 1209-13

11. Success of miniscrews used as anchorage for orthodontic treatment: analysis of different factors. Giuliano Maino B, Pagin P, Di Blasio A. Prog Orthod. 2012 Nov;13(3):202-9.

12. Hystomorphometric and mechanical analyses of the drill-free screw as orthodontic anchorage. Kim JW, Ahn SJ, Chang YIAm J Orthod Dentofacial Orthop 2005; 128: 190-4

13. Primary stability of micorscrews based on their diameter, lenght, shape and area of insertion. an experimental study with periotestOrquin M, Molina A, Puigdollers A.Prog in Orthod, 2008, 9 (2), 82-88

14. Impact of implant design on primary stability of orthodontic mini-implants Benedict Wilmes, Stephanie Ottenstreuer, Yu-Yu Su, Dieter Drescher J. Orofac. Orthop. 2008; 69: 42-50

15. Comparison of Stability between cylindrical and conical type mini-implants Jong-Wan Kim, Seung-Hak Baek, Tae-Woo Kim, Young-II ChangAngle Ortod 2008; 78 (4)

16. Root damage and repair after contact with miniscrews. Maino BG, Weiland F, Attanasi A, Zachrisson BU, Buyukyilmaz T. J Clin Orthod. 2007 Dec;41(12):762-6

17. Contact damage to root surfaces of premolars touching miniscrews during orthodontic treatment. Kadioglu O, Büyükyilmaz T, Zachrisson BU, Maino BG. Am J Orthod Dentofacial Orthop. 2008 Sep;134(3):353-60.

18. MGBM system: new protocol for Class II non extraction treatment without cooperation. Maino BG, Gianelly AA, Bednar J, Mura P, Maino G. Prog Orthod. 2007;8(1):130-43

References suggest by Donald Nelson.

1. Papadopoulos, M.A. and F. Tarawneh, The use of miniscrew implants for temporary skeletal anchorage in orthodontics: a comprehensive review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod, 2007. 103(5): p. e6-15.

2. Papadopoulos, M.A., Orthodontic treatment of Class II malocclusion with miniscrew implants. Am J Orthod Dentofacial Orthop, 2008. 134(5): p. 604 e1-16; discussion 604-5.

3. Li, F., et al., Comparison of anchorage capacity between implant and headgear during anterior segment retraction. Angle Orthod, 2011. 81(5): p. 915-22.

4. Heymann, G.C., et al., Three-dimensional analysis of maxillary protraction with intermaxillary elastics to miniplates. Am J Orthod Dentofacial Orthop, 2010. 137(2): p. 274-84.

5. Graham, J.W., Profound, needle-free anesthesia in orthodontics. J Clin Orthod, 2006. 40(12): p. 723-4.

6. Elias, C.N., A.C. de Oliveira Ruellas, and D.J. Fernandes, Orthodontic implants: concepts for the orthodontic practitioner. Int J Dent, 2012. 2012: p. 549761.

7. Kravitz, N.D. and B. Kusnoto, Risks and complications of orthodontic miniscrews. Am J Orthod Dentofacial Orthop, 2007. 131(4 Suppl): p. S43-51.

8. Cornelis, M.A., et al., Modified miniplates for temporary skeletal anchorage in orthodontics: placement and removal surgeries. J Oral Maxillofac Surg, 2008. 66(7): p. 1439-45.

9. Keim, R.G., Who places miniscrews? J Clin Orthod, 2008. 42(9): p. 489-90.10. Orthodontists, A.A.o., Informed Consent for the Orthodontic Patient - Risks and

Limitations of Orthodontic Treatment, 2005: St. Louis, MO.11. Policy, O.P.L.I., American Association of Orthodontists Insurance Company, 2008:

Montpelier, VT. p. 1-16.

12. Baxmann, M., et al., Expectations, acceptance, and preferences regarding microimplant treatment in orthodontic patients: A randomized controlled trial. Am J Orthod Dentofacial Orthop, 2010. 138(3): p. 250 e1-250 e10; discussion 250-1.

13. Cheng, S.J., et al., A prospective study of the risk factors associated with failure of mini-implants used for orthodontic anchorage. Int J Oral Maxillofac Implants, 2004. 19(1): p. 100-6.

14. Melsen, B., et al., Factors contributing to the success or failure of skeletal anchorage devices: an informal JCO survey. J Clin Orthod, 2010. 44(12): p. 714-8; quiz 743.

15. Papageorgiou, S.N., I.P. Zogakis, and M.A. Papadopoulos, Failure rates and associated risk factors of orthodontic miniscrew implants: a meta-analysis. Am J Orthod Dentofacial Orthop, 2012. 142(5): p. 577-595 e7.

16. Santiago, R.C., et al., Correlation between miniscrew stability and bone mineral density in orthodontic patients. Am J Orthod Dentofacial Orthop, 2009. 136(2): p. 243-50.

17. Crismani, A.G., et al., Miniscrews in orthodontic treatment: review and analysis of published clinical trials. Am J Orthod Dentofacial Orthop, 2010. 137(1): p. 108-13.

18. Poggio, P.M., et al., "Safe zones": a guide for miniscrew positioning in the maxillary and mandibular arch. Angle Orthod, 2006. 76(2): p. 191-7.

19. Qiu, L., et al., Accuracy of orthodontic miniscrew implantation guided by stereolithographic surgical stent based on cone-beam CT-derived 3D images. Angle Orthod, 2012. 82(2): p. 284-93.

20. Chen, Y.J., et al., A retrospective analysis of the failure rate of three different orthodontic skeletal anchorage systems. Clin Oral Implants Res, 2007. 18(6): p. 768-75.

21. Miles, R., Contemporary Class II orthodontic and orthopaedic treatment. Aust Dent J, 2008. 53(2): p. 193; author reply 193.

22. Solano-Mendoza, B., et al., Maxillary protraction at early ages. The revolution of new bone anchorage appliances. J Clin Pediatr Dent, 2012. 37(2): p. 219-29.