"COMPARISON OF TREATMENT RESPONSE TO TOPICAL PROPOLIS VERSUS STANDARD IN THE MANAGEMENT OF ORAL CANCEROUS DISORDERS AND ROLE 0F ALPHA ENOLASE(ENO1) AND GALECTIN 9(GAL9) AS POTENTIAL MARKERS FOR DETECTING ORAL CANCEROUS DISORDERS AND ORAL CANCER : A RANDOMIZED CONTROL CLINICAL TRIAL"

Phase 4

Not yet recruiting

• Conditions: Oral submucous fibrosis,

• Registration Number: CTRI/2023/11/059696
• Lead Sponsor: Maulana Azad Institute of Dental Sciences

Brief Summary

This double blind, randomized parallel group trial will be conducted on patients with Oral Submucous Fibrosis and Oral lichen planus. After inclusion and exclusion criteria, 120 patients of opmds(60 osmf and 60 olp) are enrolled in the study which will be randomized in 2 equal groups of 60 patients each (Group A1-osmf and A2-olp).  in Group A1 30 patient receives topical triamcinalone acetonide 0.1% thrice daily along with sessame oil pulling(control) where other 30 patient receive topical propolis  thrice daily along with sessame oil pulling(intervention).in group A2 ,30 patient receive  topical triamcinalone acetonide 0.1% thrice daily(control) where other 30 patient recieve topical propolis thrice daily(intervention). Regular follow-up will be done at the end of each month up to 6 months.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-29
• Study Start: 2023-11-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Clinically & histopathologically proven cases of OSMF and OLP and OSCC Any subject of age group18 to 50 years.
• Both males and females.
• A positive history of chewing areca nut or one of its commercial preparation, difficulty in swallowing and chewing, and burning sensation on eating spicy foods.(osmf) Restricted mouth opening and changes in the oral mucous membrane including the presence of palpable vertical fibrous bands, stiffness and blanching.(osmf) Â.

Exclusion Criteria

• Subjects with mouth opening less than 15 mm.
• Subjects with systemic diseases, immunocompromised patients and patients who are taking medications which may effect the result of the study.
• Pregnant and nursing women.
• Subjects who are known allergic to honey bees or bee products.
• Those patients who are not willing to participate in study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mouth Opening, Tongue Protrusion, Cheek	4 weeks up to 6 months
flexibility, VAS score,pain score.	4 weeks up to 6 months

Secondary Outcome Measures

Name	Time	Method
To evaluate whether topical propolis can be used as an alternative to topical	triamcinolone acetonide for treating OPMDs .

Trial Locations

Locations (1)

Maulana Azad Institute of Dental Sciences; 🇮🇳 Delhi, DELHI, India

Maulana Azad Institute of Dental Sciences

🇮🇳Delhi, DELHI, India

DR HARIS KY

Principal investigator

7907340658

harisibnuyousuf@gmail.com