FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Status 
Not Applicable 
 
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.

 
Close