| CTRI Number |
CTRI/2025/08/093811 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of oral tablet pentoxifylline along with injection of triamcinolone and hyaluronidase in oral cavity compared with injection of triamcinolone and hyaluronidase in oral cavity in management of decreased mouth opening |
|
Scientific Title of Study
|
Comparison between Oral Pentoxifylline and Intralesional Injection Triamcinolone Hyaluronidase vs Intralesional Injection Triamcinolone + Hyaluronidase in Management of Oral Submucous 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 |
Dr Aishwarya Chauhan Bhimji |
| Designation |
ENT Resident doctor (2nd Year) |
| Affiliation |
GMERS Medical College and Hospital, Gotri, Vadodara |
| Address |
2nd floor, Department of ENT,
GMERS Medical College and Hospital, Gotri,
Vadodara
Gujarat 390021
India
2nd floor, Department of ENT,
GMERS Medical College and Hospital, Gotri,
Vadodara
Gujarat 390021
India
Vadodara
GUJARAT
390021
India |
| Phone |
8758882892 |
| Fax |
|
| Email |
aishchauhan1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishala Pandya |
| Designation |
Professor and Dean( MS ENT) |
| Affiliation |
GMERS Medical College and Hospital, Gotri |
| Address |
2nd floor Department of ENT, GMERS Medical College and Hospital, Gotri, Vadodara
Gujarat 390021
India
2nd floor Department of ENT, GMERS Medical College and Hospital, Gotri, Vadodara
Gujarat 390021
India
Vadodara
GUJARAT
390021
India |
| Phone |
9824040485 |
| Fax |
|
| Email |
vishala_pandya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Chauhan Bhimji |
| Designation |
ENT Resident doctor (2nd year) |
| Affiliation |
GMERS MEDICAL COLLEGE AND HOSPITAL, GOTRI, VADODARA |
| Address |
2nd floor, Department of ENT,
GMERS Medical College and Hospital, Gotri, Vadodara
Gujarat 390021
2nd floor, Department of ENT,
GMERS Medical College and Hospital, Gotri, Vadodara
Gujarat 390021
Vadodara
GUJARAT
390021
India |
| Phone |
8758882892 |
| Fax |
|
| Email |
aishchauhan1@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS Medical college and hospital |
|
|
Primary Sponsor
|
| Name |
GMERS Hospital Gotri |
| Address |
Old TB campus, Gotri main road, Gotri, Vadodara 390021 |
| Type of Sponsor |
Government medical college |
|
|
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 Chauhan Bhimji |
GMERS Medical College and hospital |
2nd floor, Department of ENT, old TB campus, Gotri road, Vadodara Gujarat
Vadodara
GUJARAT |
8758882892
aishchauhan1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC GMERS MEDICAL COLLEGE AND HOSPITAL, GOTRI |
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 Triamcinolone and Hyaluronidase in management of oral submucosal fibrosis |
Half of the patients with oral submucosal fibrosis(according to khanna and andrade classification) will be given intralesional injection Triamcinolone and Hyaluronidase in a random double blind manner. intralesional injection Triamcinolone and Hyaluronidase will be given once a week for 4 weeks. Antioxidants will be given for 4 weeks. Physiotherapy will be given for 4 weeks |
| Intervention |
Oral pentoxifylline along with intralesional injection triamcinolone and hyaluronidase in management of oral submucosal fibrosis |
Half of the patients with oral submucosal fibrosis(according to khanna and andrade classification)will be given oral Pentoxifylline with intralesional injection Triamcinolone and Hyaluronidase in a random double blind manner. Oral Pentoxifylline will be given 3 times a day for 4 weeks. Intralesional injection Triamcinolone and Hyaluronidase will be given once a week for 4 weeks. Antioxidants will be given for 4 weeks. Physiotherapy will be given for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients clinically confirmed with oral submucosal fibrosis who have not undergone any previous treatment for the same.
|
|
| ExclusionCriteria |
| Details |
Congenital disease.
Pregnant and lactating woman.
Medical history of cardiovascular, gastrointestinal, nephrological and metabolic disorders.
Patients with coexisting orofacial disorders(including trauma)other than oral submucosal fibrosis that can interfere the study.
Patients with oral cancer |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Therapeutic efficacy of Oral Pentoxifylline with Intralesional Injection Triamcinolone and Hyaluronidase compared With Intralesional injection Triamcinolone and Hyaluronidase alone over 4 weeks in the treatment of submucosal fibrosis. Assessment by Khanna and Andrade Classification of Submucosal fibrosis |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tobacco Chewing duration & stage of oral sub mucosal fibrosis. |
4 Weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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 - NO
|
|
Brief Summary
|
60 study subjects will be included in the study and will be divided by double blind randomised manner, oral pentoxifylline with Intralesional injection Triamcinolone and hyaluronidase group compared with intralesional Injection Triamcinolone and hyaluronidase group. Decreased mouth opening using Khanna and Andrade stage will be recorded before and after 4 weeks of treatment. Intralesional injections will be given once a week and Tablet Pentoxifylline will be given thrice a day over 4 weeks. Oral Submucosal fibrosis stage wise division of patients will be done in randomised double blind manner.
All stages of OSMF will be included in this study. In patients with stage 5 OSMF, intralesional injection in both retromolar triangle will be given using a spinal needle. And in other stages, needle number 24 *1.5 inch will be used for intralesional injections in retromolar triangle.
All patients will be referred to physiotherapy OPD and will be given regular mouth opening exercises. All patients will be given oral antioxidants for 4 weeks.. Any adverse effects reported by the patients will be also noted. The data collected will be statistically analysed and response to pentoxifylline and Intralesional Triamcinolone and hyaluronidase compared with Intralesional Triamcinolone and hyaluronidase alone will be observed using khanna and Andrade classification of oral submucosal fibrosis( based on mouth opening between upper and lower incisors)
Grade/ Stage Maximum interincisal mouth opening I -Maximum interincisal mouth opening up to or > 35mm II-Maximum interincisal mouth opening between 25 and 35mm III-Maximum interincisal mouth opening between 15 and 25mm IV- Maximum interincisal mouth opening 5 and 15mm V-Maximum interincisal mouth opening <5 or nil |