PRESENTED BY:

Dr. Ashish Soni

Guided By:Dr. Sunil Sharma (Prof & HOD)

introduction•Oral submucous fibrosis (OSMF) is a chronic, progressive, debilitating disease of the oral mucosa involving the oropharynx and rarely the larynx.• The disease is characterized by blanching and stiffness of the oral mucosa, trismus, a burning sensation in the mouth, and hypomobility of the soft palate and tongue with loss of gustatory sensation. •It is associated with juxtaepithelial inflammatory reaction followed by a fibroelastic change of the lamina propria and epithelial atrophy leading to stiffness of the oral mucosa, causing trismus and inability to eat.

Aims and objective• Definitive therapy is not defined for the management

of oral submucous fibrosis (OSMF).

• The purpose of this study was to determine the efficacy of aloe vera gel as an adjuvant to the following treatment options in the management of OSMF.

Materials and MethodsStudy settings and cases

• A double-blind, placebo-controlled, parallel-group randomized controlled trial was conducted on 60 subjects with OSMF divided into medicinal treatment and surgical treatment 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).

• Thirty patients with grade I and grade II OSMF were planned for medicinal treatment, and 30 patients with grade III and grade IV OSMF were planned for surgical treatment.

• The patients were selected, irrespective of age, sex, religion, and socioeconomic status

• Patients with uncontrolled diabetes, compromised immunity, and chronic infection were excluded from this study.

• Routine blood and urine investigations were done, and radiographs were taken, to exclude any associated diseases or pathology.

• Follow-up assessment for various symptoms was performed, and results were analyzed using paired and unpaired Student t tests

Management• Patients were actively discouraged from consuming the identified

etiologic factors, such as pan masala, gutkha, betel quid, tobacco, and other chronic irritants such as hot and spicy food.

• All patients underwent biopsy to confirm the diagnosis and also to correlate the clinical and histopathologic findings.

• Medicinal treatment• Patients planned for medicinal treatment were given submucosal

injections twice a week of hyaluronidase (1500 IU) diluted with 1 mL of 2% lignocaine (with 1:80000 adrenaline) for the first 3 weeks.

• This was followed by submucosal injection twice a week of hyaluronidase (1500 IU) diluted in 4 mg dexamethasone and 1 mL of 2% lignocaine (with 1:80000 adrenaline) for the next 7 weeks.

• Massaging the cheek with the mouth closed, followed by physiotherapy with a Heister mouth gag for 20 minutes, was done after the submucosal injection.

Surgical treatment• Under local or general anesthesia as required in the individual case, the

fibrous bands in the buccal mucosa were palpated and incised along the occlusal line.

• A Heister mouth gag was then applied to achieve a maximal interincisal opening of 35 mm, and coronoidectomy was done.

• Suitable graft (buccal fat pad, nasolabial flap, or collagen membrane) was then placed over the mucosal defect.

• Physiotherapy with a wooden spatula from the fifth postoperative day, at least 4 to 5 times a day, for a minimum of 6 months.

• Each treatment category (medicinal and surgical) was randomly divided into 2 groups, A and B, having an equal number of patients

• Group A patients were advised whereas no such advice was given to group B patients to apply aloe vera gel.

• The 4 subgroups were labeled group A med, group A surg, group B med, and group B surg.

•Outcome assessment• The follow-up assessment of subjects was done on a twice-a-

week basis, whereas data were recorded on a weekly basis during the medicinal treatment and monthly after the completion of the treatment, up to 6 months.

• Surgically treated patients, postoperative follow-up was performed monthly up to 6 months.

• . The criteria for assessment were as follows:

• the burning sensation of the mouth was measured on a linear scale reading from 0 to 10, taking 5 as the default initial reading and benchmark;

• mouth opening was measured (in millimeters) from the incisal-most point of the labial surface of the upper central incisor to the incisal-most point of the labial surface of the lower central incisor

• tongue protrusion was measured (in millimeters) from the incisal-most point of the labial surface of the upper incisor to the tip of the dorsal surface of the tongue on maximal protrusion.

• Suppleness and elasticity of the buccal mucosa were assessed based on the distance (in centimeters) between the tips of the ear lobes on maximal cheek blowing.

Statistical analysis• The findings of various parameters were evaluated and

analyzed statistically using paired and unpaired Student t tests.

• Comparisons between group A and group B were done separately for medicinally and surgically treated patients.

• A P value of .05 was considered statistically significant.

RESULTS:-A total of 60 participants (53 men and 7 women) were

included in the study. The majority, 41 (68.3%), were 21 to

40 years of age. Male predominance was found in both

groups; in group A (n .30), 26 were men and 4 were women

(6.5:1); in group B (n . 30), 27 were men and 3 were women

(9:1).

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

Grp A Med: beginning 5.0+ 0; 10th week 0.38 + 0.47 ; 6th month 0.26+ 40Grp B Med:continuous decrease in burning sensation, 2.23 + 1.14, after completion relapse in reduction of burning sensation to 2.96 + 1.96 until the sixth month

Grp A Surg: Significant decrease (5 + 0 to 3.66 + 0.97;) 1 month after Surgery. First month to the sixth month gradual and continuous decrease.

Grp B Surg (5 + 0 to 4.03 + 0.93) 1 month after surgery. First month to the sixth month increased (4.03 + 0.95 to 4.23 + 0.75)

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

Grp A Med:Pre-treatment mean mouth opening 23.46 + 5.37 mm, increased by 13.74 mm from initiation to the 6-month. After the tenth week, further increases were not noted.Grp B Med :Pre-treatment mean mouth opening 24.0 + 7.53 mm. from initiation to the 6-month (6 mm), after the completion decrease (from 32.40 + 6.96 mm to 30.0 + 7.41 mm)Grp A Surg: Postoperative mean mouth opening after the first month was 37.46 + 2.50 mm. insignificant increase (37.46 + 2.50 mm to 38.93 + 3.32 mm) from the first month after surgery to the 6-month follow-up Grp B Surg Postoperative mean mouth opening after the first month was 37.33 + 2.12. considerable decrease (37.33 2.12 mm to 34.0 3.18 mm) during the same period.

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

Grp A & Grp B Med:increased from 26.00 + 5.83 mm to 32.13 + 6.83 mm, amount was not significantly greater than the increase in group B med (32.46 + 6.35 mm to 38.33 + 5.05 mm) from the initiation to the completion that is, by the tenth week.After completion of medicinal treatment and until the 6-month follow-up, a decrease was found in group B med (38.33 + 5.05 mm to 36.66 + 5.31 mm), compared with the slight decrease (32.13 + 6.83 mm to 31.67 + 6.66 mm) in group A med.

Grp A & Grp B Surgthe first month’s postoperative mean tongue protrusion was 22.86 + 5.08 mm in group A surg and 24.2 + 5.83 mm in group B surg. There was an insignificant increase (22.86 + 5.08 mm to 23.13 + 5.59 mm) in tongue protrusion from the first month after the surgery to the sixth month in both surgical groups

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

Grp A & Grp B Med:Ear lobe distances on cheek blowing in group A med (27.36 + 2.32 cm to 28.73 + 2.58 cm) and group B med (26.93 + 1.89 cm to 27.53 + 2.22 cm) after thecompletion of medicinal treatment were similar. There was a considerable increase in ear lobe distance in group A med from initiation to the third week (27.36 + 2.32 cm to 27.80 + 2.44 cm) and from the sixth week to the eighth week (28.07 + 2.52 cm to 28.52 + 2.56 cm) compared with group B med (from 26.93 + 1.89 cm to 27.03 + 1.91 cm in the first 3 weeks and from 27.33 + 2.10 cm to 27.50 + 2.19 cm in the sixth to eighth weeks).

Grp A & Grp B SurgSurgically treated patients, the results obtained with the mean ear lobe distance were insignificantly different from 1 month to 6 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)

Discussion• Discontinuation of the habit is the first and foremost step before treatment

planning. The treatment employed in this study was first suggested by Khanna and Andrade. According to them, patients with an early stage of OSMF should be treated medicinally, whereas patients with an advanced stage of OSMF should be treated surgically

• Aloe vera is an emollient resin and a mannoprotein containing many amino acids that have been called “wound-healing hormones.” The polysaccharides in the gel of the leaves have woundhealing, anti-inflammatory, anticancer, immunomodulatory, and gastroprotective properties

• The medicinal treatment used in this study was suggested in 1985 by Kakar et al., who studied different combinations and regimens and recommended that patients should be given a course of local injection of hyaluronidase twice a week for the first 3 weeks, followed by a combination of dexamethasone and hyaluronidase locally for the next 7 weeks, to achieve quicker and maximal improvement. Massaging of the cheek with the mouth closed and physiotherapy with a Heister mouth gag for 20 minutes were done after the submucosal injection,

• The findings in group B med for the burning sensation of the mouth are similar to the findings of Katharia et al.,13 who used injection of placental extract for 1 month in 22 patients and found a 40.21% reduction in burning sensation, whereas in group A med the reduction was as high as 92.4%. The findings of this study clearly indicate that the use of aloe vera gel along with medicinal treatment results in a remarkable improvement in the burning sensation.

• The findings for mouth opening in group B med (i.e., improvement of 35%) are similar to the findings of Katharia et al.,13 in which a 28.26% improvement with the treatment with Placentrex was found. Haque et al.14 studied the effect of interferon-gama and found a 42% gain in net mouth opening after treatment. This result is similar to finding in group A med, in which the improvement was 60.5%, which is significantly higher than the improvement in group B med. Thus, aloe vera gel used in combination with hyaluronidase and dexamethasone, along with a supplementary therapeutic regimen, was found effective for improvement in mouth opening.

• The groups with aloe vera gel application and without aloe vera gel application showed insignificant difference in improvement in tongue protrusion and had improvement levels similar to the 18.5% found after 1 month of treatment with Placentrex by Katharia et al.13 and to the 26.3% found after antioxidant therapy in a study by Gupta et al. We found that tongue protrusion measures increased by 8.69% (26.0 to 28.26 mm) in group A med in the first 2 weeks of treatment, compared with 2.68% (32.46 to 33.33 mm) in group B med, without further gains after completion of medicinal treatment. These results indicate that topical aloe vera gel may contribute to quicker improvement of tongue protrusion and maintaining tongue protrusion achieved after the completion of medicinal treatment.

• This study found a considerable increase of 1.6% (27.36 to 27.8 cm) in the ear lobe distance within the first 3 weeks of treatment in group A med, compared with only 0.37% (26.93 to 27.03 cm) in group B med, Which indicates the positive role of aloe vera gel in quicker improvement in the suppleness and elasticity of the buccal mucosa in the initial phase of the medicinal treatment.

• Surgically treated patients• In our study’s surgically treated patients, we found that all of the

grafts were well accepted. Complications such as flap loss, flap avulsion, and wound dehiscence were not encountered. Incidence of infection or necrosis of the graft was not found, although the patients applying aloe vera gel had quicker healing, better acceptance, and healthier appearance of the graft mucosa.

• In this study, a significant decrease of 26.8% (5.0 to 3.66) in burning sensation of the mouth in group A surg from before the surgery to 1 month after the surgery, compared with 19.4% (5.0 to 4.03) in group B surg, was found, which suggests a positive role of aloe vera gel in the reduction of the burning sensation from the time of surgery and during the first postoperative month.

• The mouth opening of 37.46 + 2.50 mm in group A surg and 37.33 + 2.12 mm in group B surg was maintained 1 month after the surgery. After 6 months of follow-up, there was an increase of 3.77% (37.46 to 38.93 mm) in mouth opening in group A surg, whereas there was a considerable decrease of 8.92% (37.33 to 34.0 mm) in mouth opening in group B surg

• The observation in the aloe vera group of slight increase in mouth opening indicates its importance in the prevention of relapse of the improved mouth opening achieved after surgery. The relapse in the mouth opening achieved after surgery without the application of aloe vera gel is believed to be because of the graft contracture during healing and the recurrence of fibrosis.

This study shows that no single drug regimen can provide complete relief in OSF. First and foremost intervention includes intensive counselling and cessation of the habit. Although reversal of fibrosis is not possible, it is effective in relieving the symptoms.

•Conclusion

• In conclusion, these findings indicate that the aloe vera gel was beneficial as an adjunct to medicinal and surgical approaches in the treatment of OSMF.