| CTRI Number |
CTRI/2025/06/089097 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study Comparing Medicines and Surgery for Treating Mouth Stiffness in People with Oral Submucous Fibrosis |
|
Scientific Title of Study
|
NOVEL INTERVENTIONS IN OSMF TREATMENT: COMPARING PHARMACOLOGICAL AND SURGICAL MODALITIES THROUGH A TRIPLE-ARM CLNICAL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SHARIQUE TANVEER |
| Designation |
1st YEAR RESIDENT DOCTOR |
| Affiliation |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY GOVERNMENT DENTAL COLLEGE AND HOSPITAL JAMNAGAR |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY NAVAGAM GHED JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
8887607115 |
| Fax |
|
| Email |
sharique662@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gagandeep Singh Randhawa |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY GOVERNMENT DENTAL COLLEGE AND HOSPITAL JAMNAGAR |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY NAVAGAM GHED JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9669051622 |
| Fax |
|
| Email |
randhawa@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GAGANDEEP SINGH RANDHAWA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY GOVERNMENT DENTAL COLLEGE AND HOSPITAL JAMNAGAR |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY NAVAGAM GHED JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9669051622 |
| Fax |
|
| Email |
randhawa@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Dental college and hospital Jamnagar |
|
|
Primary Sponsor
|
| Name |
Dr SHARIQUE TANVEER |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY NAVAGAM GHED JAMNAGAR |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr GAGANDEEP SINGH RANDHAWA |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY NAVAGAM GHED JAMNAGAR |
| DR NISHIT KUMAR |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY NAVAGAM GHED JAMNAGAR |
| Dr RAJBIR KAUR RANDHAWA |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY NAVAGAM GHED JAMNAGAR |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SHARIQUE TANVEER |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL JAMNAGAR |
ROOM NUMBER 4 DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY GOVERNMENT DENTAL COLLEGE AND HOSPITAL NAVAGAM GHED JAMNAGAR PINCODE 361008
Jamnagar
GUJARAT |
8887607115
sharique662@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, (2) ICD-10 Condition: K135||Oral submucous fibrosis, (3) ICD-10 Condition: K135||Oral submucous fibrosis, (4) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fibrotomy and reconstruction with Buccal Fat Pad |
Patients undergoing fibrotomy and reconstruction with Buccal Fat Pad |
| Intervention |
Intralesional Triamcinolone Hyaluronidase injections, Intralesional Platelet Rich Plasma. |
Patients will be administered Intralesional Triamcinolone Hyaluronidase injections weekly for 6 weeks. Patients undergoing Intralesional Platelet Rich Plasma injections weekly for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
53.00 Year(s) |
| Gender |
Both |
| Details |
Patients with an interincisal mouth opening between 15 to 25mm
Biopsy proven OSMF
No systemic disorders
Patients with hemoglobin greater than 10g per dl and platelet count greater than 150000 per microlitre
Patients aged between 18 to 53 years
Patients who have quit tobacco use more than 6 months ago
Patients willing to take part in the study
Available for the long term follow up |
|
| ExclusionCriteria |
| Details |
Patients with an interincisal mouth opening less than 15 mm
Patients with age less than 18 years and greater than 53 years
Currently chewing tobacco or less than 6 months of quitting of habit
Smokers
Patients having allergy to local drugs
Patients who have undergone any kind of treatment for OSMF previously
Patients with an uncontrolled systemic illness
Patients with altered hemodynamic values
Patients who have undergone treatment for malignancy any radiotherapy or chemotherapy
Women who are pregnant lactating or taking oral contraceptives
Patients who have reduced mouth opening due to reasons other than OSMF
Patients who are not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mouth opening in mm
Reduction in the burning sensation will be assessed by visual analogue scale |
Mouth opening in mm
Reduction in the burning sensation will be assessed by visual analogue scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life using Oral Health Impact Profile 14 Questionnaire |
Follow up for more than 12 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
oral submucous fibrosis is a chronic disease characterised by progressivefibrosis of the oral mucosa leading to restructed mouth opening burning sensation and difficulty in eating and speaking. It is strongly associated with areca nut chewing and is prevelant in south aisa. The condition significantly reduces the patient’s quality of life and can have long term effects if left untreated. the study evaluates three treatment modalities for osmf to determine their effectiveness in improving mouth opening and reducing symptoms like burning sensation. 60 patients will be divided into three groups. Group 1 have weekly traimcinolone injections for six weeks. Group 2 have PRP for 6 weeks. Group 3 have Surgical fibrotomy with buccal fat pad reconstruction. Patiens will be assessed for moth opening improvementsand burning sensation over 6 months with long term follow up evaluating quality of life using Oral Health Impact Profile 14 Questionnairefor more than one year. |