Effect of Laser Photobiomodulation in Improving Mouth Opening in Oral Submucous Fibrosis

NARecruitingINTERVENTIONAL
Enrollment

315

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2027

Conditions
Oral Submucous Fibrosis
Interventions
OTHER

940nm diode laser photobiomodulation

"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"

OTHER

Conventional non -Invasive management in Oral Submucous fibrosis

"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"

Trial Locations (1)

110029

RECRUITING

All India Institute of Medical Sciences, New Delhi

All Listed Sponsors
lead

Dr. Shalini Gupta

OTHER