| CTRI Number |
CTRI/2022/10/046519 [Registered on: 14/10/2022] Trial Registered Prospectively |
| Last Modified On: |
28/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check difference in laser and steroid therapy on Oral lichen planus patients . |
|
Scientific Title of Study
|
Comparative Effectiveness of Photodynamic Therapy (660nm)Vs Triamcinolone acetonide 0.1% in Symptomatic Oral Lichen planus patients and assessment of IL-1beta,IL-6,TNF-alpha and MDA Biomarkers:A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SAKSHI BATRA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
BANARAS HINDU UNIVERSITY |
| Address |
FACULTY OF DENTAL SCIENCES,ORAL MEDICINE AND RADIOLOGY UNIT,INSTITUTE OF MEDICAL SCIENCES,BANARAS HINDU UNIVERSITY
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7275567124 |
| Fax |
|
| Email |
drsakshioralmed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adit |
| Designation |
Professor |
| Affiliation |
BANARAS HINDU UNIVERSITY |
| Address |
FACULTY OF DENTAL SCIENCES,ORAL MEDICINE AND RADIOLOGY UNIT,INSTITUTE OF MEDICAL SCIENCES,BANARAS HINDU UNIVERSITY
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
adit@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adit |
| Designation |
Professor |
| Affiliation |
BANARAS HINDU UNIVERSITY |
| Address |
FACULTY OF DENTAL SCIENCES,ORAL MEDICINE AND RADIOLOGY UNIT,INSTITUTE OF MEDICAL SCIENCES,BANARAS HINDU UNIVERSITY
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
adit@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| FACULTY OF DENTAL SCIENCES,ORAL MEDICINE AND RADIOLOGY UNIT,INSTITUTE OF MEDICAL SCIENCES,BANARAS HINDU UNIVERSITY |
|
Primary Sponsor
Modification(s)
|
| Name |
Sakshi Batra |
| Address |
FACULTY OF DENTAL SCIENCES,ORAL MEDICINE AND RADIOLOGY UNIT,INSTITUTE OF MEDICAL SCIENCES,BANARAS HINDU UNIVERSITY |
| Type of Sponsor |
Government medical college |
|
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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 Sakshi Batra |
Unit of Oral Medicine and Radiology |
FACULTY OF DENTAL SCIENCES,ORAL MEDICINE AND RADIOLOGY UNIT,INSTITUTE OF MEDICAL SCIENCES,BANARAS HINDU UNIVERSITY
Varanasi
UTTAR PRADESH |
7275567124
drsakshioralmed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
subjects having symptomatic oral lichenplanus |
| Patients |
(1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.1% Triamcinolone acetonide |
Topical corticosteroid (0.1% triamcinolone acetonide), topical application 3 times daily with no food or fluid intake 1hour after application for 1 month |
| Intervention |
PHOTODYNAMIC THERAPY |
Localized photobiomodulation with low-level diode laser equipment and along with the topical application of toluidine blue on the lesion acting as a photosensitizer. Irradiated with 660nm diode laser with a continuous pulse, contact mode,100mW for 60 sec on each cm² area i.e 6J, 2times a week for 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i.Participants of both gender and age between 18 years to 60 years, will be diagnosed with symptomatic lesions of reticular, atrophic, and erosive oral lichen planus based on clinical, histopathological criteria by WHO.
ii. Patients who give informed consent after explaining the treatment type will be included in the study
|
|
| ExclusionCriteria |
| Details |
i. Patients with any other Potentially Malignant Oral Disorders (PMOD) will be excluded.
ii. Pregnant females and breastfeeding mothers will be excluded.
iii. Patients having photosensitivity will be excluded.
iv. Patients with a history of corticosteroids, NSAIDs, or any other treatment in the last 30 days will be excluded.
v. Patients with other systemic diseases or illnesses will be excluded.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain and burning sensation |
baseline,1 month,2nd month,3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| size of the lesion |
baseline,1month,2nd month,3rd month. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/10/2022 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The purpose of the study is to compare the effectiveness of photodynamic therapy (660nm) Vs. Triamcinolone acetonide 0.1% in symptomatic oral lichen planus patient and assessment of markers IL-1 beta,IL-6,TNF-alpha and MDA in both groups before and after the treatment. 30 patients randomly selected in each group. Patients in control group given topical corticosteroid (0.1%), topical application 3 times daily with no food or fluid intake 1 hour after application for 1 month. Follow-up done every week and VAS and RAE scoring once a month and at baseline(i.e baseline,1 month, 2month, 3month). Patients of the experimental group will be treated with photobiomodulation with low-level diode laser equipment and along with the topical application of toludine blue on the lesion acting as a photosensitizer. Irradiated with 660nm diode laser with a continuous pulse,contact mode ,100mW for 60 sec on each cm 2 i.e. 6j ,2 times a week for 1 month. blood and saliva sample collection done pre treatment and at 3 months of follow up.Comparative evaluation of VAS and RAE score done and ELISA test will be undertaken from the samples collected and stored for estimation of IL̵ 1 beta ,IL-6 ,TNF-alpha and the thiobarbituric acid test for MDA estimation, from this comparative evaluation of change of these salivary and serum markers, will be done to know the comparative effectiveness of both treatments |