Yes, After Taking an Informed Consent from the Patients They Shall Be Subjected to Incisional

6. Brief resume of the intended work:

6.1 Need for the study: Oral submucous fibrosis (OSMF) is one of the most preventable, prevalent, premalignant condition in India. Etiopathogenesis of disease remains elusive till today. A plethora of treatments have been advocated, hypothesized and justified by different workers like systemic administration of steroids, antioxidants, immune milk, interferon gamma and intralesional injection of enzymes, steroids and placental extracts. An ideal treatment is one which provides no morbidity, reverses the changes in mucosa and cures OSMF. Such absolutely safe and permanently successful treatment does not exist. Many incurable diseases when treated with alternate medicine like ayurveda had good prognosis which has been well documented in literature. Aloe vera has been known for centuries for its medicinal properties. It has been successfully used in the management of immune mediated diseases like oral lichen planus1 and apthous ulcers.2,3 OSMF starts as chronic inflammatory lesion with release of various chemical mediators, fibrous bands are laid down submucosally. Atrophy of epithelium occurs secondary to decreased blood supply. Decreased serum concentration of antioxidants and altered immunity has also been noted in OSMF patients. Aloe vera has anti-inflammatory (auxins, gibberlins, sterols, sugars), antioxidant (vitaminA,E,C), immunomodulating (acemannan) and angiogenic properties (beta-sitosterol) suggesting the possible benefits of using aloe vera in treatment of OSMF.4,5 So the present study has been planned to evaluate the efficacy of aloe vera in the treatment of OSMF. To the best of our knowledge, this is the first study where aloe vera will be used in the management of OSMF. 6.2 Review of Literature : A study conducted in 54 patients who were randomized into 2 groups to recieve aloe vera gel or placebo for 8 weeks of treatment. It was noted that aloe vera gel was significantly more effective than placebo in clinical and symptomatological improvement in oral lichen planus.1 A 52-year-old subject having oral lichen planus with severe systemic involvement was treated with systemic and topical aloe vera for 3 months. The oral lesions cleaned up very quickly within 4 weeks.6 A study evaluated a gel that combined allantoin, aloe vera and silicon dioxide and its effects on aphthous ulcers of the oral mucosa. Each patient used a daily dairy to document the number and duration of aphthous ulcers, the interval between ulcers, its size and pain over a period of 3 to 4 months. The gel reduced all the parameters and also increased the interval between the lesions.2 A study conducted in 90 patients with recurrent aphthous ulcers who were treated with acemannan hydrogel which is derived from aloe vera. The subjects using acemannan hydrogel healed faster than those using the over-the- counter remedy. The acemannan hydrogel did not have the disagreeable taste and texture associated with traditional therapies and did not sting when applied.3

6.3 Objectives of the study :  To evaluate the efficacy of aloe vera in the management of OSMF. 7. Material and Methods: 7.1 Source of Data: Patients attending the outpatient Department of Oral Medicine and Radiology, College of Dental Sciences, Davangere shall be included in the study, after obtaining an informed consent from the patients. 7.2 Method of Collection of the Data: A minimum of 20 patients with OSMF Inclusion Criteria: 1. Patients with OSMF diagnosed clinically and histopathologically. 2. Patients who agree for biopsy and blood examination. 3. Patients who had not taken any treatment earlier for OSMF. 4. Patients who are ready to quit the habit of gutka chewing and accepted for regular follow ups. 5. OSMF patients with mouth opening between 20-39mm. Exclusion Criteria: 1. OSMF patients with coexisting systemic illness. 2. Patients with other mucosal lesions like leukoplakia and malignant lesions. 3. History of hypersensitivity to aloe vera. 4. Pregnant women and lactating mothers. Clinical Examination and Study Parameters : A structured proforma shall be used to collect relevant information from each patient. Before commencing the treatment, patients will be counseled to quit the adverse habits. Clinical staging will be done depending upon mouth opening:  Mild cases: 30-39mm  Moderate cases: 20-29mm

The patients will be randomly divided into two groups :

Group A : Consists of 5 each mild and moderate OSMF patients who will receive Aloe vera gel marketed by Sheetal lab (Surat) in the form of 70mg gel/packet. Patients will be trained to place cotton rolls bilaterally near the opening of stenson’s duct. So that immediate flushing of aloe vera gel by saliva can be minimized. Then patients are asked to apply 5 mg of aloe vera gel topically on each side of buccal mucosa 3 times daily for 3 months.

Group B : Also consists of 5 each mild and moderate OSMF patients who will receive Oxyace capsules marketed by(Lekar pharma ltd) twice daily for 3months.

Each soft gelatin capsule consists of : Beta carotene -5mg Mixed Carotenoids-5mg Vitamin E-25 mg Chromium -200mcg Zinc - 7.5mg Manganese - 1.5mg Copper -1mg Selenium -150mcg Vitamin C-100mg

Patients will be enquired for any side effects and following parameters will be evaluated every 15 days for a period of 3months.

 Burning sensation intensity will be assessed using on numerical rating scale: Chainani N et al (2008)  Mouth opening: Bricker SL et al (2002)  Cheek flexibility: Bailoor DN and Nagesh KS (2001 ) All the results and observations will be statistically analysed.

7.3 Does the study require any investigation (or) intervention to be conducted on patient (or) other humans (or) animals? Yes, after taking an informed consent from the patients they shall be subjected to incisional biopsy and the treatment.

7.4 Has ethical clearance been obtained from your institution? Yes

8. LIST OF REFERRENCES :

1. Choonhakarn C, Busaracome P, Sripanidkulchai B, Sarakarn P. The efficacy

of aloe vera gel in the treatment of oral lichen planus: a randomized control

trail. Br J of Dermatol 2008; 158: 573-7.

2. Garnick JJ, Singh B, Winkley G. Effectiveness of a medicament containing silicon dioxide, aloe, and allontoin on apthous stomatitis. Oral Surg Oral Med Oral Path Oral Endod 1998; 86:550-6.

3. Proffit WR. Oral ulcers remedy gets FDA clearance. JADA 1994; 125:1308- 10.

4. Wynn RL. Aloe vera gel: Update for dentistry. Gen Dent 2005; 1:7-8.

5. Moon EJ, Lee YM, Lee OH, Lee MJ, Lee SK, Chung MH et al. A novel angiogenic factor derieved from Aloe vera gel: β-sitosterol, a plant sterol. Angiogen 1999; 3:117-23.

6. Hayes SM. Lichen planus- Report of successful treatment with aloe vera. Gen Dent 1999; 5:268-72.