Study: NCT06639009

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: 940nm diode laser photobiomodulation
Description: The surgical handpiece (diameter 0.6cm) will be used without the fibre optic tips in defocused mode and head sanitized before therapy.~Peak Power : 0.3Watts Power density: 1 Watt/cm2 Fluence: 4J/cm2 per cycle Spot size : 0.28cm2 Distance : 2mm from surface Mode: Continuous, Non- contact mode, circular motion, overlapping, in clockwise concentric manner with laser handpiece perpendicular to surface Duration of cycle : 25 seconds with interval of 30 seconds alternating with other side Cycles per sitting: Four for each side Four Sittings: Day 0,3, 7, and 15 Area of intervention: Bilateral buccal mucosa and masseter muscle Total treatment time per day: 430 seconds/ approx 7 minutes Total treatment time for 4 sittings: approx 28 minutes

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Conventional non -Invasive management in Oral Submucous fibrosis
Description: Brief behavioral Tobacco, areca nut and alcohol habit cessation counseling as per WHO 5As and 5Rs technique at baseline and each follow up.~Oral prophylaxis Removal of oral irritational factors like sharp teeth, appliances or prosthesis, impacted buccoverted third molars, parafunctional habits Oral hygiene maintenance instructions Oral physiotherapy Control of systemic conditions Removal of all predisposing factors for oral candida infection Advocacy for safe sexual practices Nutrition and diet counseling( seasonal and regional food rich in nutrients, vitamins, antioxidants avoidance of spicy /sour/ hot foods and drinks) Regular surveillance for malignant transformation

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Conventional non -Invasive management in Oral Submucous fibrosis
Description: Brief behavioral Tobacco, areca nut and alcohol habit cessation counseling as per WHO 5As and 5Rs technique at baseline and each follow up.~Oral prophylaxis Removal of oral irritational factors like sharp teeth, appliances or prosthesis, impacted buccoverted third molars, parafunctional habits Oral hygiene maintenance instructions Oral physiotherapy Control of systemic conditions Removal of all predisposing factors for oral candida infection Advocacy for safe sexual practices Nutrition and diet counseling( seasonal and regional food rich in nutrients, vitamins, antioxidants avoidance of spicy /sour/ hot foods and drinks) Regular surveillance for malignant transformation

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Conventional non -Invasive management in Oral Submucous fibrosis
Description: Brief behavioral Tobacco, areca nut and alcohol habit cessation counseling as per WHO 5As and 5Rs technique at baseline and each follow up.~Oral prophylaxis Removal of oral irritational factors like sharp teeth, appliances or prosthesis, impacted buccoverted third molars, parafunctional habits Oral hygiene maintenance instructions Oral physiotherapy Control of systemic conditions Removal of all predisposing factors for oral candida infection Advocacy for safe sexual practices Nutrition and diet counseling( seasonal and regional food rich in nutrients, vitamins, antioxidants avoidance of spicy /sour/ hot foods and drinks) Regular surveillance for malignant transformation