| CTRI Number |
CTRI/2025/05/087117 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to assess the effectiveness of a herbal gel formulation containing Curcumin(Turmeric) and Anthocyanin (Pomegranate) with a light source of 400nm (Low level light source) in patients with oral lichen planus |
|
Scientific Title of Study
|
Effectiveness of photodynamic therapy using Anthocyanin-Curcumin as a photosensitizer gel in the management of oral lichen planus-A split mouth randomised control 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 Dhanya |
| Designation |
Post Graduate resident |
| Affiliation |
Saveetha Dental college and Hospitals |
| Address |
Department of Oral Medicine and Radiology, Clinic No :20
No 162 Poonamallee High Road Velappanchavadi Chennai
Department of oral medicine and Radiology and Special care dentistry.
Nil
Chennai
TAMIL NADU
600077
India |
| Phone |
9840395180 |
| Fax |
5180 |
| Email |
152110003.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uma Maheswari TN |
| Designation |
Head of the Department |
| Affiliation |
Saveetha Dental college and Hospitals |
| Address |
Department of oral medicine and Radiology
No 162 Poonamallee High Road Velappanchavadi Chennai
Nil
Chennai
TAMIL NADU
600077
India |
| Phone |
9840958339 |
| Fax |
8339 |
| Email |
umamaheswaritn@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanya |
| Designation |
Post Graduate resident |
| Affiliation |
Saveetha Dental college and Hospitals |
| Address |
Department of oral medicine and Radiology
Clinic 20
No 162 Poonamallee High Road Velappanchavadi Chennai
Nil
Chennai
TAMIL NADU
600077
India |
| Phone |
9840395180 |
| Fax |
5180 |
| Email |
152110003.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals
No: 162, Vellapanchavi, Poonamallee High Road Chennai- 600077 |
|
|
Primary Sponsor
|
| Name |
Dr Dhanya M |
| Address |
No 162 Poonamallee High Road Velappanchavadi Chennai |
| 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 Dhanya |
Saveetha dental college and Hospitals |
Department of Oral medicine and Radiology, 1st Floor, Clinic 20
No 162 Poonamallee High Road vellapanchavadi chennai 600077
Chennai
TAMIL NADU |
9840395180
5180
152110003.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College -Institutional Human Ethical Commitee (SDC-HEC) |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Photodynamic therapy | (Procedure Reference: , Procedure details: Photodynamic therapy using Anthocyanin -Curcumin as a photosensitizer (Herbal)
At first the Photosensitizer (Anthocyanin and Curcumin ) is applied on the oral mucosa and after an incubation period of 10 minutes a light source of 250-400 nm is applied over it. )
| | 2 | Comparator Arm (Non Ayurveda) | | - | Photobiomodulation therapy | There is no use of a photosensitizer, instead only a low level light source is used in photobiomodulation therapy |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. clinically and Histopathologically confirmed cases of all forms of Oral lichen planus
2. Bilateral presentation of the lesions
|
|
| ExclusionCriteria |
| Details |
1. Patients with other oral potentially malignant disorders are excluded.
2. Patients with Unilateral clinical presentation of oral lichen planus are excluded.
3. Patients with oral Lichenoid reactions are excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the size of the lesion
|
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction is burning sensation |
2 years |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/06/2025 |
| 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="2"
Months="0"
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 a randomised parallel trial with a split mouth design, assessing the effectiveness of photodynamic therapy using Anthocyanin-curcumin as a photosensitizer gel. One side of the mucosa receives photodynamic therapy (PDT), whereas the other side of the same patient receives photobiomodulation therapy (PBT) as a comparator. Totally 30 sites are included in this study. This study is conducted only in India for a period of 2 years duration and further the primary outcome is measured by reduction in the lesion size and the secondary outcome is measured by assessing the reduction in pain score. |