| CTRI Number |
CTRI/2025/03/082591 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
"Natural Oil Therapy: An Innovative Approach for Managing Oral Fibrosis" |
|
Scientific Title of Study
|
Oil pulling – A novel treatment approach for Oral
sub mucous fibrosis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poka Lakshmi Bhargavi |
| Designation |
Post graduate student |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Room no1 Oral medicine &Radiology Sibar
Institute of Dental Sciences Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9381652581 |
| Fax |
|
| Email |
pokabhargavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.K.Pavani |
| Designation |
Assistant professor |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Room no1 Oral medicine &Radiology Sibar
Institute of Dental Sciences Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9381652581 |
| Fax |
|
| Email |
kothaapavani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poka Lakshmi Bhargavi |
| Designation |
Post graduate student |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Room no1 Oral medicine &Radiology Sibar
Institute of Dental Sciences Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9381652581 |
| Fax |
|
| Email |
pokabhargavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Oral Medicine and Radiology, SIBAR Institute of
dental sciences, Takellapadu , Guntur , Andhra Pradesh, 522509 |
|
|
Primary Sponsor
|
| Name |
PokaLakshmi Bhargavi |
| Address |
Room no:1, Oral medicine &Radiology,Sibar Institute of Dental Sciences, Guntur. pincode:522509 |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr POKA LAKSHMI BHARGAVI |
SIBAR INSTITUTE OF DENTAL SCIENCES |
Room no:1, Oral Medicine & Radiology, SIBAR
Institute of Dental Sciences, Guntur.
Guntur
ANDHRA PRADESH |
9381652581
pokabhargavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sibar institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oral submucous fibrosis stage - II |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
81.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
Subjects with other oral lesions along with
OSMF. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficiency of Sesame oil in Reducing in
VAS score, Improvement in mouth opening, Tongue
protrusion, Cheek flexibility |
base line
30th day & 60th day of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To check any age related or gender related
discrepancy in treatment out come |
Baseline, 30th day , 60th day |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |