A study comparing photobiomodulation and standard treatment for improving mouth opening and reducing burning sensation in patients with oral submucous fibrosis.

INTERVENTION: Intervention1: Photobiomodulation as adjunct to standard of care: In addition to standard of care, isolated oral mucosal areas with palpable fibrotic bands will undergo photobiomodulation using a diode laser with a wavelength of 810 nm and an output power of 800 mW. Each treatment session will consist of three cycles of 2 minutes each, separated by 1‐minute intervals. The laser will be applied in contact mode with a continuous sweeping motion over the affected areas. Photobiomodulation sessions will be administered once weekly for a duration of 4 weeks. Control Intervention1: Intralesional Injections and antioxidants and sham laser: Palpable fibrous bands will be treated with intralesional injections of hyaluronidase (1500 IU) and dexamethasone (2 mL of 4 mg/mL) along with 0.5 mL of 2% lignocaine with 1:200,000 adrenaline, administered biweekly for a duration of 1 month. In addition, participants will receive oral antioxidant supplementation twice daily for 4 weeks containing alpha lipoic acid, beta‐carotene, elemental copper, elemental selenium, lycopene, vitamin E, and zinc sulphate. A sham photobiomodulation procedure will be performed to simulate laser application without delivery of therapeutic laser energy.The sham procedure will be administered once weekly for 4 weeks consecutive weeks. CONDITION: Health Condition 1: K135‐ Oral submucous fibrosis PRIMARY OUTCOME: The primary outcomes of the study are change in inter‐incisal mouth opening measured in millimeters using a vernier caliper and change in burning sensation assessed using a Visual Analog ScaleTimepoint: baseline day 0, week 1, week 2, week 3 , week 4, and follow up 3 months and 6 months. SECONDARY OUTCOME: The secondary outcomes of the study include change in tongue protrusion measured in millimeters, change in serum biomarkers including superoxide dismutase, malondialdehyde, IL‐6, TGF‐beta, & TNF‐alpha assessed using ELISA, & the incidence of adverse events or side effects related to the intervention. ; Timepoint: Tongue protrusion & serum levels will be assessed at baseline day 0, & at the end of treatment i.e 4 weeks.adverse events or side effects will be monitored continuously week 1, week 2, week 3, week 4. INCLUSION CRITERIA: a. Both male and female patients above the age of 15 years. b. Patients with current or previous use of any form of smokeless tobacco and/or areca nut (any duration and frequency) c. Patients having early‐intermediate stage OSMF designated as Grade I and II by the grading system proposed by Kerr et al. d. Patients willing to quit the habit of smokeless tobacco and/or areca nut. e. Patients willing to accept regular follow‐up protocol