"Natural Oil Therapy: An Innovative Approach for Managing Oral Fibrosis"

Phase 2

Not yet recruiting

• Conditions: Oral submucous fibrosis stage - II

• Registration Number: CTRI/2025/03/082591
• Lead Sponsor: PokaLakshmi Bhargavi

Brief Summary

Aim of study : • To assess the effectiveness of oil pulling in the management of Oral submucous fibrosis Objectives of study : • To assess the effectiveness of oil pulling in tongue protrusion • To assess the effectiveness of oil pulling in cheek flexibility • To assess the effectiveness of oil pulling in burning sensation • To assess the effectiveness of oil pulling in mouth opening Methodology: • 24 subjects, visiting the department of Oral Medicine and Radiology who are clinically diagnosed with stage –II OSMF by the investigator based on Pindborg classification will be included in the study. Relevant case history and Informed consent will be taken from every individual. During the initial visit, measurements such as tongue protrusion, cheek flexibility, VAS score, and mouth opening will be recorded. Participants will be instructed to perform oil pulling with sesame oil, twice a day for 10 minutes, for a duration of 3 months. Regular monthly follow-ups will be conducted, during which the same measurements will be recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-04
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Subjects clinically diagnosed with stage II Oral submucous fibrosis (Pindborg classification) Subjects who are willing to give consent for the study.
• Subjects who are willing to quit the habit.

Exclusion Criteria

Subjects with other oral lesions along with OSMF.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficiency of Sesame oil in Reducing in	base line | 30th day & 60th day of follow up
VAS score, Improvement in mouth opening, Tongue	base line | 30th day & 60th day of follow up
protrusion, Cheek flexibility	base line | 30th day & 60th day of follow up

Secondary Outcome Measures

Name	Time	Method
To check any age related or gender related	discrepancy in treatment out come

Trial Locations

Locations (1)

SIBAR INSTITUTE OF DENTAL SCIENCES; 🇮🇳 Guntur, ANDHRA PRADESH, India

SIBAR INSTITUTE OF DENTAL SCIENCES

🇮🇳Guntur, ANDHRA PRADESH, India

Dr POKA LAKSHMI BHARGAVI

Principal investigator

9381652581

pokabhargavi@gmail.com