| CTRI Number |
CTRI/2025/05/087308 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF EFFICACY OF PENTOXIFYLLINE AND LYCOPENE WITH INTRALESIONAL DEXAMETHASONE, HYALURONIDASE IN THE TREATMENT OF ORAL SUBMUCOUS FIBROSIS |
|
Scientific Title of Study
|
Comparison of efficacy of Pentoxifylline and Lycopene with intralesional
Dexamethasone, Hyaluronidase in the treatment of Oral Submucous Fibrosis: A Randomized Controlled Clinical 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 |
K J Jalin |
| Designation |
PG Student |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL,VIJAYAWADA |
| Address |
Department of Oral Medicine and Radiology
Government Dental College and Hospital,
Vijayawada, Andhra Pradesh.
K J Jalin
Department of Oral Medicine and Radiology
Government Dental College and Hospital,
Vijayawada, Andhra Pradesh.
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
7032288366 |
| Fax |
|
| Email |
kunnelakatjalin30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Ramesh Kumar |
| Designation |
Professor and HOD |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL,VIJAYAWADA |
| Address |
Department of Oral Medicine and Radiology
Government Dental College and Hospital,
Vijayawada, Andhra Pradesh.
Department of Oral Medicine and Radiology
Government Dental College and Hospital,
Vijayawada, Andhra Pradesh.
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
7032288366 |
| Fax |
|
| Email |
ramesh99inbox@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K J Jalin |
| Designation |
PG Student |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL,VIJAYAWADA |
| Address |
Department of Oral Medicine and Radiology
Government Dental College and Hospital,
Vijayawada, Andhra Pradesh.
K J Jalin
Department of Oral Medicine and Radiology
Government Dental College and Hospital,
Vijayawada, Andhra Pradesh.
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
7032288366 |
| Fax |
|
| Email |
kunnelakatjalin30@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
K J Jalin |
| Address |
Department of Oral Medicine and Radiology
Government Dental College and Hospital,
Vijayawada, Andhra Pradesh.
|
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| K J JALIN |
Govt Dental College and Hospital, Vijayawada |
Gunadala, Vijayawada
Krishna
ANDHRA PRADESH |
7032288366
kunnelakatjalin30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT DENTAL COLLEGE AND HOSPITAL, VIJAYAWADAINSTITUTIONAL ETHICS 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 |
| Intervention |
Capsule Lycopene 10000 mcg |
Lycopene, an effective anti-oxidant from tomato extract has been
proved to be the most potent radical scavenger in various in-vivo and
in-vitro studies. Apart from its use in other health related conditions,
its antioxidant properties have also been evaluated in the management
of OSMF |
| Comparator Agent |
Intralesional
injection of Dexamethasone 1.5ml+ Intralesional injection of
Hyaluronidase 1500 IU + with 0.5ml lignocaine HCL |
corticosteroids
have shown promising results in improving mouth opening and
reducing inflammation. Synthetic corticosteroids such as dexamethasone have been
effectively administered intralesionally |
| Intervention |
T.Pentoxifylline 400mg |
pentoxifylline, a xanthine derivative, known for its vasodilating
capabilities and anti-inflammatory, fibrinolytic, immunomodulatory, effects. Pentoxifylline has been
shown to improve mouth opening and reduce the burning sensation in
OSMF patients |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients of age 21-60 years clinically diagnosed with OSMF.
2. Patients who are willing to quit the habit of chewing tobacco and areca nut.
3. Patients who will agree to come for regular follow-up visits will be included. |
|
| ExclusionCriteria |
| Details |
1. Patients who are currently under treatment for OSMF.
2. Patients under treatment for chronic systemic diseases such as Diabetes mellitus, Hypertension, Cardiovascular diseases, Bronchial asthma and Peptic ulcers.
3. Pregnant and lactating female patients.
4. OSMF patients with severe restricted mouth opening where there is no adequate access to administer intralesional injections.
5. Patients under treatment for other OPMDs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mouth opening |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Burning sensation |
18 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/05/2025 |
| 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="8"
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 aim of the study is to Compare the efficacy of oral Pentoxifylline and Lycopene with intralesional Dexamethasone, Hyaluronidase in the treatment of Oral Submucous Fibrosis. Out patients reporting to the Department of Oral Medicine and Radiology, Government Dental College and Hospital, Vijayawada who are diagnosed clinically with Oral Submucous Fibrosis and requires treatment will be enrolled in the study. Detailed history of health and habit will be taken and patient will be motivated to quit the habit. The intended procedure will be explained to every patient and an informed consent will be obtained thereafter. Selected patients will be allocated into group A and B randomly. Group A: Consists of 20 OSMF patients who will be administered Intralesional injection of dexamethasone 1.5ml+ Intralesional injection of hyaluronidase 1500 IU + with 0.5ml lignocaine HCL two times per week for a period of 8 weeks. Group B: Consists of 20 OSMF patients who will be given Tablet Pentoxifylline 400 mg thrice daily combined with oral antioxidant containing Lycopene 10,000 mcg once daily for a period of 8 weeks. |