Clinical Research Directory

Autologous PRP Versus Triamcinolone Acetate in Patients With Oral Submucous Fibrosis

Oral submucous fibrosis (OSF) is a chronic condition that causes stiffness of the oral tissues, reduced cheek flexibility, and difficulty opening the mouth. This randomized controlled clinical trial will compare the effects of intralesional autologous platelet-rich plasma (PRP) and triamcinolone acetate in patients with OSF. A total of 40 patients will be divided into two groups of 20. Group A will receive 1 ml of intralesional PRP, and Group B will receive 1 ml of intralesional triamcinolone acetate (40 mg/ml), once weekly for six weeks. Maximum interincisal distance and cheek flexibility will be measured before treatment, at six weeks, and at three months after treatment completion. The study will compare changes in these outcomes between the two groups to evaluate the effects of both treatments.

Curcumin Plus Topical Steroid Versus Topical Steroid Alone for Oral Submucous Fibrosis

This study evaluates whether combining oral curcumin (a natural compound derived from turmeric) with a topical steroid is more effective than using a topical steroid alone in treating Oral Submucous Fibrosis (OSMF). OSMF is a chronic mouth condition that can cause burning, tissue stiffness, and difficulty opening the mouth, affecting eating, speaking, and oral hygiene. Eligible participants will be randomly assigned to one of two groups: Group A: Curcumin 500 mg twice daily + 0.1% triamcinolone acetonide ointment three times daily. Group B: 0.1% triamcinolone acetonide ointment alone, three times daily. Participants will be followed for six months, with assessments at baseline, 1, 3, and 6 months. Mouth opening and burning sensation will be measured. Participation is voluntary, and all personal information will remain confidential. Participants may withdraw at any time without affecting their medical care. The study aims to determine whether the combination treatment improves mouth opening and reduces burning sensation more effectively.

Alternating Triamcinolone and Platelet-Rich Plasma Therapy for Oral Submucous Fibrosis

Oral Submucous Fibrosis (OSF) is a chronic, progressive, potentially malignant disorder characterized by mucosal stiffness, trismus, and burning sensation. This interventional clinical trial evaluates the therapeutic effectiveness of alternating weekly intralesional Triamcinolone Acetonide (TA) and Platelet-Rich Plasma (PRP) injections compared to standard Triamcinolone therapy alone. The purpose is to determine whether sequential anti-inflammatory (TA) and regenerative (PRP) stimulation can produce superior clinical improvement in mouth opening, burning sensation, and mucosal flexibility compared to corticosteroid therapy alone.

Comparison of Curcumin and Intralesional Steroids in Oral Submucous Fibrosis

The goal of this clinical trial is to learn if Curcumin is better than Intralesional Steroid Injection for the treatment of oral submucous fibrosis. The main question it aims to answers are: 1. If Curcumin is more effective to improve burning sensation as compared to Intralesional steroid. 2. Does Curcumin treatment results in better mouth opening versus Intralesional steroid. 3. Can Curcumin helps to improve tongue protrusion as compared to Intralesional steroids. Participants will be: * Assessed for one month, two month and three month. * Burning Sensation will be assessed with visual analogue scale (VAS). * Mouth Opening will be measured in mm with ruler. * Tongue Protrusion will be assessed with the visual analogue scale (VAS).

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

This a patient and outcome assessor blinded, multiple arm, randomized placebo controlled clinical trial. The goal of the study is to study the adjunctive effect of 940nm laser photobiomodulation therapy (PBMT) in precancerous condition like moderate Oral submucous Fibrosis in increasing the mouth opening. It will also assess the the effect of PBMT on oral burning sensation cheek flexibility, electromyography of bilateral masseter muscle, inflammatory and fibrogenic cytokines and oral health quality of life at baseline and after 1 and 3 months of PBMT. Adult subjects fulfilling the selection criteria will be prospectively recruited after ethical clearance and informed written consent. They will be randomized into 3 groups in 1:1 :1 distribution The three groups are as follows: Group A: Photobiomodulation therapy given intraorally on bilateral buccal mucosa and extraorally (sham) with conventional non-invasive management. Group B: Photobiomodulation therapy given intraorally (bilateral buccal mucosa) and extraorally (bilateral masseter muscle) with conventional non-invasive management. Group C: Sham (Use of laser handpiece with only red guide light and without using the foot pedal which activates the laser)Photobiomodulation therapy(Placebo) (Intraoral and Extraoral) with conventional non-invasive management. The conventional non invasive management in Oral submucous fibrosis which all the groups will receive are as follows: 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(Mouth opening and cheek ballooning exercises) Control of systemic conditions (Anemia, Diabetes, hypertension, thyroid disorders) by specialist referral 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 All the outcome parameters will be assessed at baseline and 1 and 3 months after PBMT.