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Efcacy of aloe vera gel as an adjuvant treatment of oral submucous brosis Sarwar Alam, MDS, a Iqbal Ali, MDS, b K.Y. Giri, MDS, c S. Gokkulakrishnan, MDS, d Subodh S. Natu, MDS, e Mohammad Faisal, MDS, f Anshita Agarwal, MDS, g and Himanshu Sharma, MDS a Institute of Dental Sciences, Bareilly, Uttar Pradesh; Career Post Graduate Institute of Dental Sciences and Hospital, Lucknow, Uttar Pradesh; Jamia Millia Islamia, New Delhi; Vananchal Dental College and Hospital, Garhwa, Jharkhand, India Objective. Definitive therapy is not defined for the management of oral submucous fibrosis (OSMF). This study evaluated the efficacy of aloe vera gel as an adjuvant treatment of OSMF. Study Design. A double-blind, placebo-controlled, parallel-group randomized controlled trial was conducted on 60 subjects with OSMF divided into medicinal treatment (submucosal injection of hyaluronidase and dexamethasone, n ¼ 30) and surgical treatment (n ¼ 30) categories. Each category was randomly divided into groups A (with aloe vera, n ¼ 15 per category) and B (without aloe vera, n ¼ 15 per category). Follow-up assessment for various symptoms was performed, and results were analyzed using paired and unpaired Student t tests. Results. The group receiving aloe vera had a significant improvement in most symptoms of OSMF (P < .01) compared with the nonealoe vera group, in both the medicinal and surgical categories. Conclusions. Aloe vera gel was effective as an adjuvant in treatment of OSMF. (Oral Surg Oral Med Oral Pathol Oral Radiol 2013;116:717-724) Oral submucous brosis (OSMF) is a chronic, progres- sive, debilitating disease of the oral mucosa involving the oropharynx and rarely the larynx. 1 The disease is char- acterized by blanching and stiffness of the oral mucosa, trismus, a burning sensation in the mouth, and hypo- mobility of the soft palate and tongue with loss of gustatory sensation. It is associated with juxtaepithelial inammatory reaction followed by a broelastic change of the lamina propria and epithelial atrophy leading to stiffness of the oral mucosa, causing trismus and inability to eat. 2 This disease is generally noted in South Asian populations or among those who have emigrated from South Asia. Other geographic clustering may be noted in Burma (Myanmar), with sporadic cases observed in southern Vietnam, Thailand, China, and Nepal. 2 The prevalence of OSMF in random samples of the population in India is up to 0.4%. This indicates that there may be millions of persons with OSMF. This disease is increasing rapidly in India, corresponding to the current upsurge in the popularity of various manu- factured areca nut preparations, such as mawa and pan masala. The prevalence of OSMF is found to be 6.42 per 1000, and the male-to-female ratio, 4.9:1. Signicantly younger persons (age <30 years) are increasingly affected by this disease. 3 OSMF commonly involves the soft palate (91.4%), buccal mucosa (72.4%), retro- molar region (70.7%), and tongue (8.6%), 4 and the condition is considered precancerous. 5 Malignant transformation of OSMF has been reported to be from 2.3% to 7.6%. 3,6 The established etiologic factors are areca nut, 7 chilies, 8 vitamin B deciencies, and genetic and immu- nologic predisposition. 7,9 The pathogenesis is believed to involve juxtaepithelial inammatory reaction and brosis in the oral mucosa, probably owing to increased cross- linking of collagen through upregulation of lysyl oxidase activity. Fibrosis, or the buildup of collagen, results from the effects of areca nut, which increase collagen production (e.g., stimulated by arecoline, an alkaloid) and decrease collagen degradation. Thus, OSMF is now considered a collagen metabolic disorder. a Senior Lecturer, Department of Oral and Maxillofacial Surgery, Institute of Dental Sciences, Bareilly, Uttar Pradesh. b Professor and Head, Department of Oral and Maxillofacial Surgery, Career Post Graduate Institute of Dental Sciences and Hospital, Lucknow, Uttar Pradesh. c Professor, Department of Oral and Maxillofacial Surgery, Institute of Dental Sciences, Bareilly, Uttar Pradesh. d Professor and Head, Department of Oral and Maxillofacial Surgery, Institute of Dental Sciences, Bareilly, Uttar Pradesh. e Senior Lecturer, Department of Oral and Maxillofacial Surgery, Career Post Graduate Institute of Dental Sciences and Hospital, Lucknow, Uttar Pradesh. f Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Jamia Millia Islamia, New Delhi. g Senior Lecturer, Department of Oral Pathology, Vananchal Dental College and Hospital, Garhwa, Jharkhand. Received for publication Apr 10, 2013; returned for revision Aug 1, 2013; accepted for publication Aug 5, 2013. Ó 2013 Elsevier Inc. All rights reserved. 2212-4403/$ - see front matter http://dx.doi.org/10.1016/j.oooo.2013.08.003 Statement of Clinical Relevance Aloe vera gel was effective as an adjuvant in the treatment of oral submucous brosis, a premalignant condition prevalent in South Asia. 717 Vol. 116 No. 6 December 2013

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Page 1: alo vera

Vol. 116 No. 6 December 2013

Efficacy of aloe vera gel as an adjuvant treatment of oralsubmucous fibrosisSarwar Alam, MDS,a Iqbal Ali, MDS,b K.Y. Giri, MDS,c S. Gokkulakrishnan, MDS,d Subodh S. Natu, MDS,e

Mohammad Faisal, MDS,f Anshita Agarwal, MDS,g and Himanshu Sharma, MDSa

Institute of Dental Sciences, Bareilly, Uttar Pradesh; Career Post Graduate Institute of Dental Sciences and Hospital, Lucknow, Uttar Pradesh; JamiaMillia Islamia, New Delhi; Vananchal Dental College and Hospital, Garhwa, Jharkhand, India

Objective. Definitive therapy is not defined for the management of oral submucous fibrosis (OSMF). This study evaluated the

efficacy of aloe vera gel as an adjuvant treatment of OSMF.

Study Design. A double-blind, placebo-controlled, parallel-group randomized controlled trial was conducted on 60 subjects

with OSMF divided into medicinal treatment (submucosal injection of hyaluronidase and dexamethasone, n ¼ 30) and

surgical treatment (n ¼ 30) categories. Each category was randomly divided into groups A (with aloe vera, n ¼ 15 per category)

and B (without aloe vera, n ¼ 15 per category). Follow-up assessment for various symptoms was performed, and results were

analyzed using paired and unpaired Student t tests.

Results. The group receiving aloe vera had a significant improvement in most symptoms of OSMF (P < .01) compared with the

nonealoe vera group, in both the medicinal and surgical categories.

Conclusions. Aloe vera gel was effective as an adjuvant in treatment of OSMF. (Oral Surg Oral Med Oral Pathol Oral Radiol

2013;116:717-724)

Oral submucous fibrosis (OSMF) is a chronic, progres-sive, debilitating disease of the oral mucosa involving theoropharynx and rarely the larynx.1 The disease is char-acterized by blanching and stiffness of the oral mucosa,trismus, a burning sensation in the mouth, and hypo-mobility of the soft palate and tongue with loss ofgustatory sensation. It is associated with juxtaepithelialinflammatory reaction followed by a fibroelastic changeof the lamina propria and epithelial atrophy leading tostiffness of the oral mucosa, causing trismus and inabilityto eat.2 This disease is generally noted in South Asianpopulations or among those who have emigrated fromSouth Asia. Other geographic clustering may be notedin Burma (Myanmar), with sporadic cases observedin southern Vietnam, Thailand, China, and Nepal.2 Theprevalence of OSMF in random samples of the

aSenior Lecturer, Department of Oral and Maxillofacial Surgery,Institute of Dental Sciences, Bareilly, Uttar Pradesh.bProfessor and Head, Department of Oral and Maxillofacial Surgery,Career Post Graduate Institute of Dental Sciences and Hospital,Lucknow, Uttar Pradesh.cProfessor, Department of Oral and Maxillofacial Surgery, Institute ofDental Sciences, Bareilly, Uttar Pradesh.dProfessor and Head, Department of Oral and Maxillofacial Surgery,Institute of Dental Sciences, Bareilly, Uttar Pradesh.eSenior Lecturer, Department of Oral and Maxillofacial Surgery,Career Post Graduate Institute of Dental Sciences and Hospital,Lucknow, Uttar Pradesh.fAssociate Professor, Department of Oral and Maxillofacial Surgery,Faculty of Dentistry, Jamia Millia Islamia, New Delhi.gSenior Lecturer, Department of Oral Pathology, Vananchal DentalCollege and Hospital, Garhwa, Jharkhand.Received for publication Apr 10, 2013; returned for revision Aug 1,2013; accepted for publication Aug 5, 2013.� 2013 Elsevier Inc. All rights reserved.2212-4403/$ - see front matterhttp://dx.doi.org/10.1016/j.oooo.2013.08.003

population in India is up to 0.4%. This indicates thatthere may be millions of persons with OSMF. Thisdisease is increasing rapidly in India, corresponding tothe current upsurge in the popularity of various manu-factured areca nut preparations, such as mawa and panmasala.

The prevalence of OSMF is found to be 6.42 per1000, and the male-to-female ratio, 4.9:1. Significantlyyounger persons (age <30 years) are increasinglyaffected by this disease.3 OSMF commonly involvesthe soft palate (91.4%), buccal mucosa (72.4%), retro-molar region (70.7%), and tongue (8.6%),4 and thecondition is considered precancerous.5 Malignanttransformation of OSMF has been reported to be from2.3% to 7.6%.3,6

The established etiologic factors are areca nut,7

chilies,8 vitamin B deficiencies, and genetic and immu-nologic predisposition.7,9 The pathogenesis is believed toinvolve juxtaepithelial inflammatory reaction and fibrosisin the oral mucosa, probably owing to increased cross-linking of collagen through upregulation of lysyl oxidaseactivity. Fibrosis, or the buildup of collagen, resultsfrom the effects of areca nut, which increase collagenproduction (e.g., stimulated by arecoline, an alkaloid)and decrease collagen degradation. Thus, OSMF is nowconsidered a collagen metabolic disorder.

Statement of Clinical Relevance

Aloe vera gel was effective as an adjuvant in thetreatment of oral submucous fibrosis, a premalignantcondition prevalent in South Asia.

717

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718 Alam et al. December 2013

Clinical management of OSMF continues to beunsatisfactory. Signs and symptoms persist and progressdespite attempted treatments. Several categories of drugsare used to treat debilitating fibrosis. However, the effectis not satisfactory. No single drug has effectively reversedthe initiation and development of OSMF, for multiplereasons, such as the progressive nature of the disease, thelack of complete knowledge of the pathogenesis of thedisease, and the limited routes of administration. It isimportant to investigate the means of controlling thischronic progressive and symptomatic illness, consideringits troublesome symptoms, precancerous nature, andprevalence in a vast geographic region.

An attempt has been made to study the effect oftopical aloe vera gel as an adjuvant to the treatment.Although satisfactory treatment is not yet recognized, 2treatment options have been used with some benefit.The purpose of this study was to determine the efficacyof aloe vera gel as an adjuvant to the following treat-ment options in the management of OSMF.

i. Submucosal local injection of (Hyalase hyaluroni-dase 1500 IU; Wockhardt UK, Wrexham, UK)diluted with 1 mL of 2% lignocaine (with 1:80000adrenaline) twice a week for the first 3 weeks; fol-lowed by submucosal local injection of hyaluronidasediluted with 4 mg dexamethasone and 1 mL of 2%lignocaine (with 1:80000 adrenaline) twice a weekfor the next 7 weeks.

ii. Surgical excision of fibrotic bands, with or withoutgraft.

MATERIALS AND METHODSStudy settings and casesA double-blind, placebo-controlled, parallel-group ran-domized controlled trial was carried out to evaluate theefficacy of aloe vera gel as an adjuvant to the medicinaland surgical treatment of OSMF among 60 patientsdiagnosed with the disease. The patients were selected,irrespective of age, sex, religion, and socioeconomicstatus, from all those attending the outpatient Departmentof Oral and Maxillofacial Surgery at Career Post Grad-uate Institute of Dental Sciences and Hospital, Lucknow,Uttar Pradesh, India. Patients with uncontrolled diabetes,compromised immunity, and chronic infection wereexcluded from this study. Routine blood and urineinvestigations were done, and radiographs were taken, toexclude any associated diseases or pathology.

The study protocol was reviewed and approved bythe Institutional Ethical Committee. The treatmentplan was explained to all the study participants, andtheir consent was obtained. Patients were gradedaccording to the classification given by Khanna andAndrade.10 Thirty patients with grade I and grade IIOSMF were planned for medicinal treatment, and 30

patients with grade III and grade IV OSMF wereplanned for surgical treatment.

ManagementPatients were actively discouraged from consuming theidentified etiologic factors, such as pan masala, gutkha,betel quid, tobacco, and other chronic irritants such ashot and spicy food. Patients with anemia were treatedand encouraged to eat a well-balanced diet. All patientsunderwent biopsy to confirm the diagnosis and also tocorrelate the clinical and histopathologic findings. Inci-sional biopsies were taken from the retromolar andbuccal mucosal regions. Additional biopsies were takenfrom areas that showed clinical alterations in the mucosasuggestive of atypia or malignant transformation.

All patients were put on a supplementary therapeuticregimen of Lycostar (lycopene, 5000 mg; carotene,10.33 mg; refined wheat germ oil, 25 mg; zinc sulfate,27.45 mg; and selenium dioxide, 75 mg; MankindPharma Ltd., New Delhi, India) twice daily andCapsule Becosules-Z (Pfizer Ltd., USA. thiamine, 10mg; riboflavin, 10 mg; pyridoxine, 3 mg; vitamin B12,15 mg; niacinamide, 100 mg; calcium pantothenate, 50mg; folic acid, 1.5 mg; biotin, 100 mg; ascorbic acid, 50mg; and zinc sulfate, 41.4 mg, equivalent to 15 mg ofelemental zinc) once daily during the treatment and upto 6 months after the completion of treatment. Theywere advised to perform physiotherapy for mouthopening 4 to 5 times a day on a regular basis.

Impacted or malposed third molars having possiblecorrelation with the prognosis of OSMF treatment wereremoved. All possible foci of infections were eradi-cated. Correction of local irritants, such as a sharptooth, was performed. Fractured and carious teeth wererestored. Oral prophylaxis was provided. Patients wereassessed after 2 weeks; and after they gave assurancethat they had suspended the habit as instructed, furthermanagement was continued.

Medicinal treatment. Patients planned for medici-nal treatment were given submucosal injections twicea week of hyaluronidase (1500 IU) diluted with 1 mL of2% lignocaine (with 1:80000 adrenaline) for the first 3weeks. This was followed by submucosal injectiontwice a week of hyaluronidase (1500 IU) diluted in4 mg dexamethasone and 1 mL of 2% lignocaine (with1:80000 adrenaline) for the next 7 weeks. The entirecontent of the syringe was injected using a 26-gaugeneedle, with not more than 0.2 mL of solution per site.Massaging the cheek with the mouth closed, followedby physiotherapy with a Heister mouth gag for 20minutes, was done after the submucosal injection.

Surgical treatment. Under local or general anesthesiaas required in the individual case, the fibrous bands inthe buccal mucosa were palpated and incised along the

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occlusal line, starting from the angle of the mouthextending posteriorly up to the retromolar region, bilat-erally, to the depth of connective tissue. A Heister mouthgag was then applied to achieve a maximal interincisalopening of 35 mm, and coronoidectomy was done whererequired to get the maximal possible opening.

Suitable graft (buccal fat pad, nasolabial flap, orcollagen membrane) was then placed over the mucosaldefect. Patients were placed on physiotherapy witha wooden spatula from the fifth postoperative day, atleast 4 to 5 times a day, for a minimum of 6 months.

Each treatment category (medicinal and surgical) wasrandomly divided into 2 groups, A and B, having anequal number of patients. Group A patients were advisedto apply aloe vera gel over the buccal mucosa, palate,retromolar region, and floor of the mouth twice dailyduring the treatment as well as in the follow-up phase, upto 6 months after the completion of medicinal or surgicaltreatment, whereas no such advice was given to group Bpatients (Figure 1). The 4 subgroups were labeled groupA med, group A surg, group B med, and group B surg.

Outcome assessmentThe follow-up assessment of subjects was done ona twice-a-week basis, whereas data were recorded ona weekly basis during the medicinal treatment andmonthly after the completion of the treatment, up to 6months. Neither local nor systemic side effects werenoted in the groups. In surgically treated patients,postoperative follow-up was performed monthly up to 6months. The criteria for assessment were as follows: theburning sensation of the mouth was measured ona linear scale reading from 0 to 10, taking 5 as thedefault initial reading and benchmark; mouth openingwas measured (in millimeters) from the incisal-mostpoint of the labial surface of the upper central incisor tothe incisal-most point of the labial surface of the lowercentral incisor or (for partially edentulous participants)in between the anterior-most teeth present in botharches; tongue protrusion was measured (in millime-ters) from the incisal-most point of the labial surface ofthe upper incisor to the tip of the dorsal surface of thetongue on maximal protrusion or (for partially edentu-lous participants) from the anterior-most teeth presentto the tip of the dorsal surface of the tongue on maximalprotrusion. Suppleness and elasticity of the buccalmucosa were assessed based on the distance (in centi-meters) between the tips of the ear lobes on maximalcheek blowing.

Statistical analysisData obtained were analyzed with SPSS software(version 15; SPSS Inc, Chicago, IL, USA). The findingsof various parameters were evaluated and analyzed

statistically using paired and unpaired Student t tests.Comparisons between group A and group B were doneseparately for medicinally and surgically treatedpatients. A P value of �.05 was considered statisticallysignificant.

RESULTSA total of 60 participants (53 men and 7 women) wereincluded in the study. The majority, 41 (68.3%), were21 to 40 years of age. Male predominance was found inboth groups; in group A (n ¼ 30), 26 were men and 4were women (6.5:1); in group B (n ¼ 30), 27 were menand 3 were women (9:1).

Figure 2 shows that there was a significant decrease(P < .01) in the mouth burning sensation for themedicinal treatment in group A (group A med) from thebeginning of the treatment (5.0 � 0 on the rating scale)to the completion of the medicinal therapy (tenth week;0.38 � 0.47), with further reduction at the end of thesixth month (0.26 � 0.40). In group B med, during thetreatment time, patients had a continuous decrease inburning sensation, 2.23 � 1.14, but after completion oftreatment there was relapse in reduction of burningsensation to 2.96 � 1.96 until the sixth month. Aconsiderable decrease in burning sensation was noticedafter week 2 of treatment in group A med (1.73 � 1.01)compared with group B med (3.53 � 1.17) against theinitial benchmark reading of 5 � 0.

In the surgically treated patients, a significantdecrease in the burning sensation was observed ingroup A surg (5 � 0 to 3.66 � 0.97; P < .01) but not ingroup B surg (5 � 0 to 4.03 � 0.93) 1 month aftersurgery. The burning sensation increased (4.03 � 0.95to 4.23 � 0.75) in group B surg from the first month tothe sixth month postoperatively, whereas there wasa gradual and continuous decrease in burning sensationin group A surg during the same observation period(see Figure 2).

At baseline, the pretreatment mean mouth openingin medicinally treated patients (Figure 3) was 23.46 �5.37 mm and 24.0 � 7.53 mm in group A med andgroup B med, respectively (P > .05). Mouth openingincreased in group A med by 13.74 mm from initiationto the 6-month follow-up, an amount more than twicethat found in group B med (6 mm) (P < .01). After thetenth week, further increases were not noted. In fact,after the completion of the medicinal therapy, therewas decrease in mouth opening in group B med (from32.40 � 6.96 mm to 30.0 � 7.41 mm) over months 2through 6, whereas group A med remained essentiallystable.

In the surgically treated patients, the postoperativemean mouth opening after the first month was 37.46 �2.50 mm in group A (group A surg) and 37.33 � 2.12mm in group B (group B surg; P > .05). In group A

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Fig. 2. Comparison of the burning sensation of the mouth between group A and group B in patients treated medicinally andsurgically.

Fig. 1. Flow chart of the inclusion of subjects.

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720 Alam et al. December 2013

surg, there was an insignificant increase in mouthopening (37.46 � 2.50 mm to 38.93 � 3.32 mm) fromthe first month after surgery to the 6-month follow-up(P > .05), whereas in group B surg, there wasconsiderable decrease (37.33 � 2.12 mm to 34.0 � 3.18mm) in mouth opening during the same period (seeFigure 3).

Tongue protrusion (Figure 4) increased in group Amed from 26.00 � 5.83 mm to 32.13 � 6.83 mm,although the amount was not significantly greaterthan the increase in group B med (32.46 � 6.35 mm to38.33 � 5.05 mm) from the initiation to the completionof the injectable therapy, that is, by the tenth week.After completion of medicinal treatment and until the

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Fig. 3. Comparison of mouth opening between group A and group B in patients treated medicinally and surgically.

Fig. 4. Comparison of tongue protrusion between group A and group B in patients treated medicinally and surgically.

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6-month follow-up, a decrease was found in group Bmed (38.33 � 5.05 mm to 36.66 � 5.31 mm),compared with the slight decrease (32.13 � 6.83 mm to31.67 � 6.66 mm) in group A med.

Among surgically treated patients, the first month’spostoperative mean tongue protrusion was 22.86 �5.08 mm in group A surg and 24.2 � 5.83 mm in groupB surg (P > .05). There was an insignificant increase(22.86 � 5.08 mm to 23.13 � 5.59 mm) in tongueprotrusion from the first month after the surgery to thesixth month in both surgical groups (see Figure 4).Also, ear lobe distances on cheek blowing in group Amed (27.36 � 2.32 cm to 28.73 � 2.58 cm) and groupB med (26.93 � 1.89 cm to 27.53 � 2.22 cm) after thecompletion of medicinal treatment were similar. Therewas a considerable increase (Figure 5) in ear lobedistance in group A med from initiation to the thirdweek (27.36 � 2.32 cm to 27.80 � 2.44 cm) and fromthe sixth week to the eighth week (28.07 � 2.52 cm to

28.52 � 2.56 cm) compared with group B med (from26.93 � 1.89 cm to 27.03 � 1.91 cm in the first 3weeks and from 27.33 � 2.10 cm to 27.50 � 2.19 cm inthe sixth to eighth weeks). Among surgically treatedpatients, the results obtained with the mean ear lobedistance were insignificantly different from 1 month to6 months after surgery between group A surg (26.53 �2.2 cm to 27.10 � 2.46 cm) and group B surg (27.96 �2.72 cm to 27.53 � 2.81 cm) (see Figure 5).

DISCUSSIONTo date, there has been no ideal treatment available forOSMF. Discontinuation of the habit is the first andforemost step before treatment planning. The treatmentemployed in this study was first suggested by Khannaand Andrade.10 According to them, patients with anearly stage of OSMF should be treated medicinally,whereas patients with an advanced stage of OSMFshould be treated surgically. Aloe vera is an emollient

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Fig. 5. Comparison of ear lobe distance on cheek blowing between group A and group B in patients treated medicinally andsurgically.

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722 Alam et al. December 2013

resin and a mannoprotein containing many amino acidsthat have been called “wound-healing hormones.” Thepolysaccharides in the gel of the leaves have wound-healing, anti-inflammatory, anticancer, immunomodu-latory, and gastroprotective properties.11

The medicinal treatment used in our study was sug-gested in 1985 by Kakar et al.,12 who studied differentcombinations and regimens and recommended thatpatients should be given a course of local injection ofhyaluronidase twice a week for the first 3 weeks, fol-lowed by a combination of dexamethasone and hyal-uronidase locally for the next 7 weeks, to achievequicker and maximal improvement. Massaging of thecheek with the mouth closed and physiotherapy witha Heister mouth gag for 20 minutes were done after thesubmucosal injection, as Borle and Borle1 found thatthe mechanical insults due to insertion of injectionneedles and chemical irritation of injected fluids aftera certain time aggravate fibrosis, trismus, dysphagia,and other morbidity, owing to the progressive nature ofthe disease.1

The findings in group B med for the burningsensation of the mouth are similar to the findingsof Katharia et al.,13 who used injection of placentalextract (Placentrex, Albert David Ltd, Kolkata, WestBengal, India) for 1 month in 22 patients and founda 40.21% reduction in burning sensation, whereas inour group A med the reduction was as high as 92.4%.The findings of this study clearly indicate that the useof aloe vera gel along with medicinal treatment resultsin a remarkable improvement in the burning sensation.In group A med, there was a constant decrease in theburning sensation, even after the completion of treat-ment and up to the 6-month follow-up (from 0.38to 0.26), whereas there was a relapse in reductionof burning sensation (2.23 to 2.96) in group B med. Thisfinding indicates that aloe vera gel, along with supple-mentary therapeutic drugs and vitamins, continues toreduce the burning sensation even after the completion

of medicinal therapy, whereas there is relapse withoutaloe vera gel application.

The findings for mouth opening in group B med (i.e.,improvement of 35%) are similar to the findings ofKatharia et al.,13 in which a 28.26% improvement withthe treatment with Placentrex was found. Haque et al.14

studied the effect of interferon-g and found a 42%gain in net mouth opening after treatment. The mouthopening improvement found by Lin and Lin15 was 64%to 82% after 6 weeks of treatment with collagenaseinjection. This result is similar to our finding in groupA med, in which the improvement was 60.5%, whichis significantly higher than the improvement in groupB med. Thus, aloe vera gel used in combination withhyaluronidase and dexamethasone, along with a sup-plementary therapeutic regimen, was found effectivefor improvement in mouth opening. Also, the mouthopening achieved after the completion of medicinaltreatment is maintained in the follow-up period in groupA med (aloe vera), whereas relapse was observed ingroup B med (no aloe vera).

The groups with aloe vera gel application andwithout aloe vera gel application showed insignificantdifference in improvement in tongue protrusion andhad improvement levels similar to the 18.5% foundafter 1 month of treatment with Placentrex by Kathariaet al.13 and to the 26.3% found after antioxidant therapyin a study by Gupta et al.16 We found that tongueprotrusion measures increased by 8.69% (26.0 to 28.26mm) in group A med in the first 2 weeks of treatment,compared with 2.68% (32.46 to 33.33 mm) in group Bmed, without further gains after completion of medic-inal treatment. These results indicate that topical aloevera gel may contribute to quicker improvement oftongue protrusion and maintaining tongue protrusionachieved after the completion of medicinal treatment.Here it is important to mention that the restriction oftongue mobility is not only because of the fibrosis ofthe tongue but also because of the involvement of the

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retromolar area and the floor of the mouth. The afore-mentioned result can be attributed to an increase in thelaxity of the retromolar area and the floor of the mouthafter the treatment.

For mean ear lobe distance, which is indicativeof suppleness and elasticity of the buccal mucosa andwas measured with cheek blowing in the group treatedmedicinally, no significant difference was found bet-ween the groups from the initiation to the completionof standard medicinal treatment. Kakar et al.12 foundimprovement in the suppleness of the oral tissue in66.7%, 83.7%, 91.7%, and 70.8% of patients treatedwith dexamethasone, hyaluronidase, a combination ofhyaluronidase and dexamethasone, and Placentrex,respectively, for 10 weeks. Our study found a consid-erable increase of 1.6% (27.36 to 27.8 cm) in the earlobe distance within the first 3 weeks of treatment ingroup A med, compared with only 0.37% (26.93 to27.03 cm) in group B med, which indicates the positiverole of aloe vera gel in quicker improvement in thesuppleness and elasticity of the buccal mucosa in theinitial phase of the medicinal treatment.

Surgically treated patientsIn our study’s surgically treated patients, we foundthat all of the grafts were well accepted. Complica-tions such as flap loss, flap avulsion, and wounddehiscence were not encountered. Incidence of infec-tion or necrosis of the graft was not found, althoughthe patients applying aloe vera gel had quicker heal-ing, better acceptance, and healthier appearance of thegraft mucosa.

In this study, a significant decrease of 26.8% (5.0to 3.66) in burning sensation of the mouth in group Asurg from before the surgery to 1 month after thesurgery, compared with 19.4% (5.0 to 4.03) in group Bsurg, was found, which suggests a positive role of aloevera gel in the reduction of the burning sensation fromthe time of surgery and during the first postoperativemonth. The reduction in burning sensation after thesurgery to improve the mouth opening is possiblybecause of the removal of the mucosa responsiblefor the burning sensation and the replacement withhealthier and disease-free graft mucosa, along withthe effect of aloe vera gel application. In a study byBorle et al.,17 41 out of 47 patients reported reductionin the burning sensation after the surgery without anysupplementary medicinal treatment, although therewere no data available on the percentage of reduc-tion in burning sensation. There was a considerablereduction of 47.26% (3.66 to 1.93) in the burningsensation in our group A surg from the first monthafter surgery to the 6-month follow-up, compared witha slight relapse of 6.69% (4.03 to 4.30) in group B

surg, which is similar to that with Placentrex injection(40.21%) found by Katharia et al.,13 suggesting thebenefits of aloe vera gel application along with thesupplementary therapeutic drugs and vitamins advisedin our study.

The mouth opening of 37.46 � 2.50 mm in group Asurg and 37.33 � 2.12 mm in group B surg wasmaintained 1 month after the surgery. After 6 monthsof follow-up, there was an increase of 3.77% (37.46 to38.93 mm) in mouth opening in group A surg, whereasthere was a considerable decrease of 8.92% (37.33 to34.0 mm) in mouth opening in group B surg. Findingsfrom Borle et al.17 found no relapse in mouth opening2 years after surgery in which they used an extendednasolabial graft followed by physiotherapy withoutany supplementary therapeutic regimen. In contrast,Mehrotra et al.2 found 0.7% to 1.8% relapse in mouthopening during the months after surgery with buccalfat pad, tongue flap, nasolabial flap, and skin grafting,which was similar to our finding of relapse in thegroup without aloe vera gel application. Yeh18 usedbuccal fat pad for reconstruction of buccal mucosaafter surgery to release fibrotic bands and found 10.2%of relapse in the mouth opening achieved after surgeryafter the follow-up period of 10 to 38 months. In thestudy by Khanna and Andrade,10 in which they useda palatal island flap, a mean relapse of 12.22% wasfound over a period of 4 years postoperatively; and Laiet al.19 found a 23% decrease in mouth opening in50% of their patients with split-thickness skin graft,in 62% of the patients with fresh amnion graft, and in32% of the patients with buccal fat pad graft, after 2years of follow-up. The observation in the aloe veragroup of slight increase in mouth opening indicatesits importance in the prevention of relapse of theimproved mouth opening achieved after surgery. Therelapse in the mouth opening achieved after surgerywithout the application of aloe vera gel is believed tobe because of the graft contracture during healing andthe recurrence of fibrosis.

In conclusion, our findings indicate that the aloe veragel was beneficial as an adjunct to medicinal andsurgical approaches in the treatment of OSMF. Furtherstudy with longer follow-up periods and larger samplesizes is required to assess the role of aloe vera gel asa mainstream therapeutic regimen.

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Reprint requests:

Sarwar Alam19, Staff Residence, Institute of Dental SciencesBareilly-243006, Uttar [email protected]