| CTRI Number |
CTRI/2024/02/063136 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the effect of Oral Laser Light vs. Medication in Treating oral lichen planus which is a disease that causes burning sensation in mouth. |
|
Scientific Title of Study
|
Comparison of the Efficacy of Photodynamic Therapy (Methylene blue using Soft Tissue Diode LASER) with Topical Tacrolimus in the Management of patients with Oral Lichen planus- Two arm double blinded 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 Aparna Raj |
| Designation |
Junior resident |
| Affiliation |
Peoples college of Dental sciences and Research centre,Bhopal,M.p |
| Address |
Department of OMDR Peoples college of Dental sciences and Research centre Bhanpur Bhopal M.p
CBCT Centre, Peoples college of Dental sciences and Research centre Bhanpur Bhopal M.p
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9650249975 |
| Fax |
|
| Email |
aparnarajsingh1513@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annette Bhambal |
| Designation |
Professor (GUIDE) |
| Affiliation |
Peoples college of Dental sciences and Research centre,Bhopal,M.p |
| Address |
Department of OMDR Peoples college of Dental sciences and Research centre Bhopal M.p
Department of OMDR ,CBCT Centre Peoples college of Dental sciences and Research centre Bhopal M.p
Bhopal
MADHYA PRADESH
480661
India |
| Phone |
9826088574 |
| Fax |
|
| Email |
drabhambal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annette Bhambal |
| Designation |
Professor |
| Affiliation |
Peoples college of Dental sciences and Research centre,Bhopal,M.p |
| Address |
Department of OMDR Peoples college of Dental sciences and Research centre Bhopal M.p
Department of OMDR CBCT Centre Peoples college of Dental sciences and Research centre Bhopal M.p
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9826088574 |
| Fax |
|
| Email |
drabhambal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples College of Dental sciences and Research centre Bhopal Madhya Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Aparna Raj |
| Address |
Department of OMDR sciences and research centre bhopal M.P |
| Type of Sponsor |
Other [self] |
|
|
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 Aparna Raj |
1. PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTRE |
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY,ROOM NO. 03,BLOCK A
Bhopal
MADHYA PRADESH |
9650249975
aparnarajsingh1513@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethic committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Photodynamic therapy(LASERS) |
once a week for 2 months. |
| Comparator Agent |
Tacrolimus |
topical application twice a day for 2 months.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
clinically and histopathologically cofirmed cases of lichen planus,
patients who have cleared the patch test for tacrollimus
participants wiiling to be part of the study and have signed informed consent |
|
| ExclusionCriteria |
| Details |
patients having other autoimmune disorders.
patients who are already under going gtreatment for lichen planus.
pregnant and lactating women.
patient with allergies to methyllene blue,tacrollimus,LASERS |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Independent variables- Tacrolimus, Photodynamic therapy
Dependent variables-burning sensation,pain,size of lesion |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dependent variables - Dependent variable-Burning sensation, pain, size of the lesion
Independent variables- Tacrolimus, Photodynamic therapy
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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 2 |
|
Date of First Enrollment (India)
|
02/03/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study is the Two arm concurrent parallel experimental study Comparing of the efficacy of Photodynamic Therapy(Methylene blue using soft tissue diode LASER)with Topical Tacrolimus in the management of patients with Oral Lichen Planus. It is the study for post-graduation Main dissertation/thesis and will be done in the institution in the Department of Oral Medicine and Radiology of PCDS, Bhopal,M.P. | |