| CTRI Number |
CTRI/2023/11/059696 [Registered on: 09/11/2023] Trial Registered Prospectively |
| Last Modified On: |
29/10/2023 |
| 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
|
"COMPARISON OF TREATMENT RESPONSE TO TOPICAL PROPOLIS VERSUS STANDARD IN THE MANAGEMENT OF ORAL CANCEROUS DISORDERS AND ROLE 0F ALPHA ENOLASE(ENO1) AND GALECTIN 9(GAL9) AS POTENTIAL MARKERS FOR DETECTING ORAL CANCEROUS DISORDERS AND ORAL CANCER : A RANDOMIZED CONTROL CLINICAL TRIAL" |
|
Scientific Title of Study
|
"COMPARISON OF TREATMENT RESPONSE TO TOPICAL PROPOLIS FORTIFIED WITH VITAMINS VERSUS TRIAMCINOLONE ACETONIDE IN THE MANAGEMENT OF ORAL POTENTIALLY MALIGNANT DISORDERS AND ROLE OF ALPHA ENOLASE(ENO1) AND GALECTIN 9(GAL9) AS CRITICAL REGULATORS FOR ORAL POTENTIALLY MALIGNANT DISORDERS AND ORAL SQUAMOUS CELL CARCINOMA: A RANDOMIZED CONTROL 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 |
DR HARIS KY |
| Designation |
Post Graduate Student |
| Affiliation |
MAULANA AZAD INSTITUTE OF DENTAL SCIENCES |
| Address |
Room no 1,Department of oral medicine and Radiology, Maulana Azad Institute of Dental Sciences, Maulana Azad Medical College Campus, Bahadur Shah Zafar Marg, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
7907340658 |
| Fax |
|
| Email |
HARISIBNUYOUSUF@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUJOY GHOSH |
| Designation |
PROFESSOR |
| Affiliation |
MAULANA AZAD INSTITUTE OF DENTAL SCIENCES |
| Address |
Room no 2,Department of Oral Medicine and Radiology ,Maulana Azad Institute of Dental Sciences, Maulana Azad Medical College Campus, Bahadur Shah Zafar Marg, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
95829111387 |
| Fax |
|
| Email |
DRSUJOYGHOSH@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR SUJOY GHOSH |
| Designation |
PROFESSOR |
| Affiliation |
MAULANA AZAD INSTITUTE OF DENTAL SCIENCES |
| Address |
Room no 2,Department of Oral Medicine and Radiology ,Maulana Azad Institute of Dental Sciences, Maulana Azad Medical College Campus, Bahadur Shah Zafar Marg, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
95829111387 |
| Fax |
|
| Email |
DRSUJOYGHOSH@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Institute of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Institute of Dental Sciences |
| Address |
Mirdard Marg, Bahadur Shah Zafar Marg, LNJP Colony, New Delhi -
110002
|
| 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 HARIS KY |
Maulana Azad Institute of Dental Sciences |
Room No. 1,Department of Oral
Medicine and Radiology, Maulana Azad Medical College Campus, Bahadur Shah Zafar Marg, New Delhi,Delhi,110002
New Delhi
DELHI |
7907340658
harisibnuyousuf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maulana Azad Institute of Dental Sciences |
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 |
Propolis |
Topical application of Propolis thrice daily for 6 months.Follow up at regular interval of 4 weeks up to 6 months. |
| Comparator Agent |
Triamcinalone acetonide |
Topical application of 0.1%
Triamcinolone acetonide thrice daily for 6 months.Follow up at regular interval of 4 weeks up to 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Clinically & histopathologically proven cases of OSMF and OLP and OSCC
Any subject of age group18 to 50 years.
Both males and females.
A positive history of chewing areca nut or one of its commercial preparation, difficulty in swallowing and chewing, and burning sensation on eating spicy foods.(osmf)
Restricted mouth opening and changes in the oral mucous membrane including the presence of palpable vertical fibrous bands, stiffness and blanching.(osmf)
Â
|
|
| ExclusionCriteria |
| Details |
Subjects with mouth opening less than 15 mm.
Subjects with systemic diseases, immunocompromised patients and patients who are taking medications which may effect the result of the study.
Pregnant and nursing women.
Subjects who are known allergic to honey bees or bee products.
Those patients who are not willing to participate in study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mouth Opening, Tongue Protrusion, Cheek
flexibility, VAS score,pain score. |
4 weeks up to 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate whether topical propolis can be used as an alternative to topical
triamcinolone acetonide for treating OPMDs .
|
4 weeks up to 6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 4 |
|
Date of First Enrollment (India)
|
23/11/2023 |
| 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 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
|
This double blind, randomized parallel group trial will be conducted on patients with Oral Submucous Fibrosis and Oral lichen planus. After inclusion and exclusion criteria, 120 patients of opmds(60 osmf and 60 olp) are enrolled in the study which will be randomized in 2 equal groups of 60 patients each (Group A1-osmf and A2-olp). in Group A1 30 patient receives topical triamcinalone acetonide 0.1% thrice daily along with sessame oil pulling(control) where other 30 patient receive topical propolis thrice daily along with sessame oil pulling(intervention).in group A2 ,30 patient receive topical triamcinalone acetonide 0.1% thrice daily(control) where other 30 patient recieve topical propolis thrice daily(intervention). Regular follow-up will be done at the end of each month up to 6 months. |