| CTRI Number |
CTRI/2025/07/090605 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Mouth Patches vs. Injections of Dexamethasone and Hyaluronidase in Treating Stage II Oral Stiffness - OSMF : A Clinical Trial |
|
Scientific Title of Study
|
Comparative Evaluation of Efficacy of Dexamethasone 4mg and Hyaluronidase 0.5mg Mucoadhesive Patch with Intralesional Injection of Dexamethasone and Hyaluronidase for Oral Submucous Fibrosis Stage II: A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwarya Bhave |
| Designation |
PG Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,Hingna |
| Address |
Department of oral medicine and radiology -03 ,Swargiya dadasaheb Kalmegh Smruti Dental College and Hospital,Hingna,Nagpur.
MAHARASHTRA
441110
India |
| Phone |
9881630712 |
| Fax |
|
| Email |
aishwaryabhave2810@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ashish Lanjekar |
| Designation |
Professor and Head of the Department of oral medicine and radiology |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,Hingna |
| Address |
Department of oral medicine and radiology -03 ,Swargiya dadasaheb Kalmegh Smruti Dental College and Hospital,Hingna,Nagpur.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9595052481 |
| Fax |
|
| Email |
ashish.lanjekar@sdk-dentalcollege.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Aishwarya Bhave |
| Designation |
PG Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,Hingna |
| Address |
Department of oral medicine and radiology -03 ,Swargiya dadasaheb Kalmegh Smruti Dental College and Hospital,Hingna,Nagpur.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9881630712 |
| Fax |
|
| Email |
aishwaryabhave2810@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,Hingna,Nagpur,Maharashtra-441110. |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Bhave |
| Address |
Department of oral medicine and radiology -03 ,Swargiya dadasaheb Kalmegh Smruti Dental College and Hospital,Hingna,Nagpur,Maharashtra-441110. |
| 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 Aishwarya Bhave |
Swargiya dadasaheb Kalmegh Smruti Dental College and Hospital |
Department of oral medicine and radiology -03.
Nagpur
MAHARASHTRA |
09881630712
aishwaryabhave2810@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituational ethical committee |
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 |
Intralesional injection having combination of 1.5ml of 4mg of dexamethasone |
Patients (40 subjects) will be given intralesional injection having combination of 1.5ml of 4mg of dexamethasone +1500 IU Hyaluronidase ;2ml of 2% of lignocaine two times a week, along with mouth opening exercises for a period of 3 months |
| Intervention |
Patients receive a Mucoadhesive Patch containing
Dexamethasone 4 mg
Hyaluronidase 0.5 mg |
Patients (40 subjects) will be given mucoadhesive patch having combination of 4mg of dexamethasone & 0.5 mg of Hyaluronidase two times a week along with mouth opening exercises for a period of 3 months
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged between 16 to 60 years
No history of prior treatment for the same
Patients with OSMF stage II
|
|
| ExclusionCriteria |
| Details |
Patients with known history of hypersensitivity to dexamethasone & hyaluronidase
Patients who are diagnosed with other intra oral lesions
Pregnant women and lactating mothers
Immunocompromised patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in mouth opening |
baseline, 1st, 2nd, and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in burning sensation |
baseline, 1st, 2nd, and 3rd month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
16/07/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aishwaryabhave2810@gmail.com].
- For how long will this data be available start date provided 25-06-2026 and end date provided 25-06-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This randomized controlled trial aims to compare a non invasive mucoadhesive patch containing 4 mg dexamethasone and point 5 mg hyaluronidase applied twice weekly with mouth opening exercises versus traditional intralesional injections 4 mg dexamethasone 1500 IU hyaluronidase lignocaine in 80 Stage II Oral Submucous Fibrosis patients over a 3 month period The study conducted in a Central India oral medicine department will assess improvements in interincisal mouth opening and reduction of burning sensation using vernier caliper measurements and VAS scores at monthly intervals Data will be analyzed with STATA t tests ANOVA non parametric tests as needed with significance set at p 005 Results could validate a sustained release patient friendly patch as a viable alternative to injections improving compliance and comfort in OSMF management |