| CTRI Number |
CTRI/2026/02/103654 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
treatment of oral submucous fibrosis |
|
Scientific Title of Study
|
Comparison of efficacy of Lycopene and Xantinol Nicotinate in the management of patients with OSMF: A Randomized 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 |
AMIT TIWARI |
| Designation |
PG student |
| Affiliation |
peoples college of dental sciences and research center bhopal |
| Address |
peoples college of dental sciences and research center
department of oral medicine and radiology.room no.G2
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9169885966 |
| Fax |
|
| Email |
amitt0315@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PALLAK CHOUDHARY |
| Designation |
PROFESSOR |
| Affiliation |
peoples college of dental sciences and research center bhopal |
| Address |
PEOPLES COLLEGE OD DENTAL SCIENCE CAMPUS
department of oral medicine . room no. G2
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8461868282 |
| Fax |
|
| Email |
6jainpalak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AMIT TIWARI |
| Designation |
PG student |
| Affiliation |
peoples college of dental sciences and research center bhopal |
| Address |
PANCHWATI COLONY ,118/8 KAROND BHOPAL
department of oral medicine and radiology .room no.G1
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
09453577522 |
| Fax |
|
| Email |
amitt0315@gmail.com |
|
|
Source of Monetary or Material Support
|
| AMIT TIWARI
PEOPLE COLLEGE OF DENTAL SCIENC AND RESEACH CENTER BHOPAL PIN CODE- 462037 India |
|
|
Primary Sponsor
|
| Name |
OTHER |
| Address |
PEOPLE COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTER BHOPAL. |
| Type of Sponsor |
Other [] |
|
|
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 |
| peoples college of dental science and research center bhopal |
peoples college of dental sciences and research center |
department of oral medicine and radiology. room no G1
Bhopal
MADHYA PRADESH |
9169885966
amitt0315@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PEOPLES COLLEGE OF DENTAL SCIENCE AND RESEARCH CENTER |
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: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
lycopene |
Antioxidant
dosage-40 mg TDS oral route |
| Intervention |
Xantinol nicotinate |
1)Drug name- Xntinol nicotinate injection(vasodilator from Pentoxyphylline group)
2)dose -2ml
3)route of adminsitration-intralessional in oral cavity in buccal musoca
4) duration- twice a weeks for 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of either gender aged between 18-45 years.
2)Consumption of areca nut and its products.
3)Exhibiting signs and symptoms of OSMF.
4)Patients with no history of any treatment for Oral submucous fibrosis in the past 6 months.
5)Patients willing to participate and ready for regular follow-ups.
6)Patients willing to quit habits
|
|
| ExclusionCriteria |
| Details |
1)Patients with other mucosal disorders with clinical features same as oral submucous fibrosis.
2)Patients on anticoagulants.
3)Pregnant patients.
4)History of recent myocardial infarction, cerebrovascular accidents, severely compromised cardiac function, and caffeine or theophylline intolerance.
5)Patients hypersensitive to Xantinol nicotinate
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mouth opening(interincisinal distance) |
2 months (every 1 weeks follow up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| burning sensation (VAS score) |
2 months(every 1 weeks follow up) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/02/2026 |
| 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="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
|
|
1)Excessive
deposition of collagen fibers leads to occluded blood vessels which in turn
lead to hyper-coagulabilty of blood. Hyper coagulated blood acts as an
obstacle in the path of nutrients and therapeutic substances to reach the
affected tissues.
2) This may
be one of the prime reasons behind failure of drug treatment in OSMF
3) Xantinol nicotinate, a peripheral vasodilator when
injected intralesionally may prove to be highly effective in the treatment of
OSMF.
4) However,
the numbers of reported randomized clinical trials are limited .
|
Also, lycopene and intralesionally
Xantinol nicotinate has not been researched extensively in management of OSMF. |