Effectiveness of Oxitard Gel Versus Physiotherapeutic and Pharmacological Interventions in Alleviating Oral Submucous Fibrosis: A Phase-II Randomized Control Trial

Effectiveness of Oxitard Gel Versus Physiotherapeutic and Pharmacological Interventions in Alleviating Oral Submucous Fibrosis: A Phase-II Randomized Control Trial Background Oral Submucous Fibrosis (OSMF) is a chronic, potentially malignant disorder of the oral mucosa. It causes progressively restricted mouth opening, reduced tongue protrusion with depapillation, submucosal fibrosis, blanching and loss of mucosal elasticity, and a shrunken uvula. It most often affects the buccal mucosa, palate and retromolar region, followed by the faucial pillars and pharynx. It is most common in South Asia. Areca nut chewing is the main cause, and commercial products such as gutka, pan masala and mawa add to the burden. Iron, vitamin B12 and folate deficiencies and capsaicin from chillies may also contribute. Irritants in areca nut and chillies trigger a juxta-epithelial inflammatory reaction. This shows first as burning, then vesicles, then ulceration. The epithelium becomes atrophic and poorly vascularised, so it heals poorly and scars. That scarring produces the fibrosis that restricts mouth opening, tongue movement and cheek flexibility. Treatment begins with stopping the habit. Early and intermediate cases are managed without surgery, usually with oral physiotherapy as an add-on. Operational Definition (Haider et al.) Clinical staging: Stage 1 is faucial bands only, Stage 2 is faucial and buccal bands, and Stage 3 is faucial, buccal and labial bands. Functional staging: Stage A is mouth opening of 20 mm or more, Stage B is 11-19 mm, and Stage C is 10 mm or less. Aim and Objectives The study compares conventional treatment (physiotherapy exercises plus multivitamins) with contemporary treatment (a novel herbal gel and Shekar's intraoral appliance) in OSMF patients. Its objectives are: Record sociodemographic and clinical features to categorise patients. Assess how well the herbal gel works. Assess how well Shekar's appliance works. Compare both contemporary treatments with conventional therapy. Hypotheses Null: there is no difference between conventional and contemporary treatments. Alternate: there is a significant difference between them. Methodology Design: pilot randomised controlled trial. Setting: Department of Oral Medicine, Dow International Dental College (DIDC), Karachi. Patients come from DIDC Hospital and Dr. Ishrat-ul-Ibad Khan Institute of Oral Health Sciences. Inclusion: OSMF patients with limited mouth opening, burning, fibrotic bands and blanched mucosa, in Haider Clinical Stages 1-2 and Functional Stages A-B. Exclusion: leukoplakic, erythroplakic or speckled lesions, non-healing ulcers or suspected malignancy; TMJ dysfunction; psychiatric disorders; other lesions that cause burning; and hypersensitivity to any ingredient of the gel or vitamins. Sample and allocation: 5 patients per group, 20 in total. The size was calculated in OpenEpi (95% confidence, 80% power). Patients are recruited by consecutive sampling and assigned to groups by a computer-generated random sequence. Herbal gel: made by Nutrimed Laboratories. It contains 1% each of Nigella sativa, tulsi, aloe vera, curcumin and lycopene, plus 0.1% vitamin E, in a carbomer 974P base. Data Collection and Blinding The study needs IRB approval from DUHS, and every participant gives written informed consent. Oral Medicine staff who are not on the research team do the examinations. A dental assistant keeps the group allocation sealed until the results are complete. Participants are not told which treatment they receive. The outcomes are: Mouth opening: measured between the incisors with a vernier caliper Burning sensation: Visual Analogue Scale (VAS) Cheek flexibility: measured at rest and with cheeks blown; the difference is recorded Tongue protrusion: in mm Mucosal colour: digital photographs Complete Blood Count: at the start and end of the study Intervention Groups Group 1: physiotherapy 3 times a day for 30 minutes, plus Pentovit H twice daily. Group 2: physiotherapy plus the herbal gel 3 times a day, with nothing to eat or drink for 30 minutes after each application. Group 3: Shekar's appliance 3 times a day for 15 minutes, plus Pentovit H. Group 4: Shekar's appliance 3 times a day for 15 minutes, plus the herbal gel 3 times a day. Patients log their compliance on record sheets that don't name their treatment. Follow-up, Duration and Analysis Patients are reviewed every 15 days for 3 months (6 visits), with a final CBC at the end. The study will take 9-12 months. Paired t-tests will measure change within each group, and unpaired t-tests will compare the groups, with p \< 0.05 counted as significant.

Inclusion criteria Patients diagnosed with OSMF who present with limited mouth opening, burning sensation, fibrotic bands and blanched mucosa. Patients in Haider et al. Clinical Stage 1 or 2 (faucial bands only, or faucial plus buccal bands) and Functional Stage A or B (mouth opening of 11 mm or more). Exclusion criteria Patients whose OSMF has a leukoplakic, erythroplakic or speckled appearance, has non-healing ulcers, or is suspected of malignancy on clinical examination or biopsy. Patients with any temporomandibular joint (TMJ) dysfunction. Patients with psychiatric disorders. Patients with other oral lesions that cause burning, such as aphthous stomatitis, burning mouth syndrome and vesiculobullous diseases. Patients with hypersensitivity to any ingredient of the gel or to any vitamin