| CTRI Number |
CTRI/2025/07/090615 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Dentistry Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use Of turmeric gel instead of steroidal gel therapy to check the effectiveness of both gel in Oral submucous fibrosis cases |
|
Scientific Title of Study
|
Effectiveness of curcumin oral gel and triamcinolone acetonide gel in the treatment of Oral sub mucous fibrosis: A Randomised Control trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akanksha Varshney |
| Designation |
post graduate student |
| Affiliation |
Institute of Dental Sciences, |
| Address |
Room No. 202, Department of Public Health Dentistry, Institute of Dental Sciences, Bareilly International University, Pilibhit bypass Road, Bareilly,243006 Room No. 202, Department of Public Health Dentistry,
Institute of Dental Sciences, Bareilly International University, Pilibhit bypass Road, Bareilly,243006 Bareilly UTTAR PRADESH 243001 India |
| Phone |
07906603227 |
| Fax |
|
| Email |
varshneyakanksha50@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Chanchal Gangwar |
| Designation |
Reader , Department of Public health dentistry |
| Affiliation |
Institute of Dental Sciences, |
| Address |
Room No. 202, Department of Public Health Dentistry,
Institute of Dental Sciences, Bareilly International University, Pilibhit bypass Road, Bareilly,243006 Room No. 202, Department of Public Health Dentistry,
Institute of Dental Sciences, Bareilly International University, Pilibhit bypass Road, Bareilly,243006 Bareilly UTTAR PRADESH 243001 India |
| Phone |
9027094243 |
| Fax |
|
| Email |
chanchalgangwar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Akanksha Varshney |
| Designation |
post graduate student |
| Affiliation |
Institute of Dental Sciences, |
| Address |
Room No. 202, Department of public health dentistry, Institute of Dental Sciences,Bareilly International University, Pillibhit bypass Road, Bareilly Room No. 202, Department of public health dentistry, Institute of Dental Sciences,Bareilly International University, Pillibhit bypass Road, Bareilly,243006 Bareilly UTTAR PRADESH 243006 India |
| Phone |
07906603227 |
| Fax |
|
| Email |
varshneyakanksha50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of dental science, Bareilly International University, Bareilly, 243006 |
|
|
Primary Sponsor
|
| Name |
Dr Akanksha Varshney |
| Address |
Institute of Dental Sciences, Bareilly |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Chanchal Gangwar |
Room No.202, Department of Public Health dentistry, Institute of dental Sciences, Bareilly, 243006 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akanksha Varshney |
Institute of Dental Sciences Bareilly |
Room No. 202 , Post graduate Department ,Department of Public Health Dentistry.
Bareilly UTTAR PRADESH |
07906603227
varshneyakanksha50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IDS Bareilly UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
corticosteroid gel |
patient is clinical diagnosed with oral submucous fibrosis, after that consent is taken and parameters are recorded, Instructions given for the process of topical application for curcumin gel groups, pea sized amount of gel should be applied by massaging it on buccal mucosa. Patients were instructed to rinse mouth with water after 10–15 min and refrain to eat anything for about 30 minutes before and after the application of gel. |
| Intervention |
Curcumin extract gel |
patient is clinical diagnosed with oral submucous fibrosis, after that consent is taken and parameters are recorded, Instructions given for the process of topical application for curcumin gel groups, pea sized amount of gel should be applied by massaging it on buccal mucosa. Patients were instructed to rinse mouth with water after 10–15 min and refrain to eat anything for about 30 minutes before and after the application of gel. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with functionally diagnosed with oral submucous fibrosis of Grade 1 and Grade 2
2 Patients who wants to give their consent and attend scheduled follow-ups
3 Patients who were willing to quit the habit
|
|
| ExclusionCriteria |
| Details |
1 Patients who have received any additional medical care for same in last three months
2 History of systemic disease with surgical and non-surgical therapy six month prior study
3 History of chemotherapy, myocardial infarction
4 Alcohol intoxication
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| burning sensations, Inter- incisal length, tongue protusion |
Baseline, 14 day , 30 day, 45 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The complete information about the study will be informed to the participants as mentioned in the participant information sheet (Appendix I). Signed informed consent will be obtained from all the participating subjects after explaining the complete procedure in their vernacular language (Appendix II). A modified case history performa will be used to collect data from the subjects (Appendix III). Clinical test will be carried out for a total sample of 70 patients with clinical and functional diagnosis of Oral Submucous Fibrosis (stage1 and stage 2 according to as mentioned in heider SM8 classification and were classified into functional stages A, B, and C. In stage A, the MO >20 mm, stage B MO 11–19 mm, and stage C=<10. Patients will be randomly allocated into two groups of 35 patients each using simple random sampling technique. GROUP A- CURCUMIN ORAL GEL GROUP B- TRIAMCINOLONE ACETONIDE ORAL GEL. During the first visit of the patient, all three parameters i.e Burning sensation, Inter- incisal length, tongue protrusion at the baseline will be measured along with modified case history performa. Inter-incisal length (mouth opening)- will be measured with a vernier caliper from maxillary central incisor to mandibular central incisor tooth in millimetre9. Burning sensation- will be recorded using VAS (Visual Analog Scale)10 scale (0-10) 0-1 will be no burning sensation ,2-4 will be mild burning sensation,5-7 will be tolerable burning sensation and 8-10 will be strongest burning sensation10. Tongue protrusion- will be assessed and recorded by extension of tip of protruded tongue from mesial contact area of maxillary central incisors using divider and scale11. First Visit- After being clinically diagnosed with OSMF stage 1 & 2. The procedure will be explained to the patient in the vernacular language (annexure I) and consent will be taken (annexure II). After that all the three baseline values for required parameters will be recorded. Instructions given for the process of topical application for both groups, pea sized amount of gel should be applied by massaging it on buccal mucosa. Patients were instructed to rinse mouth with water after 10–15 min and refrain to eat anything for about 30 minutes before and after the application of gel. The patients will be advised to quit the areca nut/ betel nut chewing habit along with proper explanation and training of physiotherapy exercises (mouth opening)1. Second Visit (14th day) and Third visit (30th day)- Patients will revisit the hospital, all the required parameters will be recorded and patients will be instructed to continue Oral gel application as well as motivated to abstain from areca nut/ betel nut chewing. They will also be advised to continue the physiotherapy exercises for mouth opening. The patients will be asked to report after 30st days and same protocol will be followed.Fourth visit (45th day)- Patients will visit the hospital, clinical examination, and all the required parameters will be recorded. Also patients will be advised to abstain from areca nut/ betel nut chewing habit. |