| CTRI Number |
CTRI/2022/11/047522 [Registered on: 22/11/2022] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry
Other (Specify) [LASER THERAPY] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TREATMENT OF BURNING SENSATION OF GUMS USING LIGHT APPLICATION |
|
Scientific Title of Study
|
Management of desquamative gingival lesions of Oral Lichen Planus using Laser Patterned Microcoagulation - An Open Labeled Clinical Trial (LPM TRIAL) |
| Trial Acronym |
LPM-TRIAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARAVANAN SP |
| Designation |
CLASSIFIED SPECIALIST PERIODONTICS |
| Affiliation |
ARMY DENTAL CENTRE RESEARCH AND REFERRAL |
| Address |
ARMY DENTAL CENTRE RESEARCH AND REFERRAL
NEW DELHI
ARMY DENTAL CENTRE RESEARCH AND REFERRAL
NEW DELHI
South
DELHI
110010
India |
| Phone |
9637110906 |
| Fax |
|
| Email |
drsaravanan.sp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SARAVANAN SP |
| Designation |
CLASSIFIED SPECIALIST PERIODONTICS |
| Affiliation |
ARMY DENTAL CENTRE RESEARCH AND REFERRAL |
| Address |
ARMY DENTAL CENTRE RESEARCH AND REFERRAL
NEW DELHI
ARMY DENTAL CENTRE RESEARCH AND REFERRAL
NEW DELHI
DELHI
110010
India |
| Phone |
9637110906 |
| Fax |
|
| Email |
drsaravanan.sp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SARAVANAN SP |
| Designation |
CLASSIFIED SPECIALIST PERIODONTICS |
| Affiliation |
ARMY DENTAL CENTRE RESEARCH AND REFERRAL |
| Address |
ARMY DENTAL CENTRE RESEARCH AND REFERRAL
NEW DELHI
ARMY DENTAL CENTRE RESEARCH AND REFERRAL
NEW DELHI
DELHI
110010
India |
| Phone |
9637110906 |
| Fax |
|
| Email |
drsaravanan.sp@gmail.com |
|
|
Source of Monetary or Material Support
|
| DGLP OF ARMY DENTAL CENTRE DELHI |
|
|
Primary Sponsor
|
| Name |
MINISTRY OF DEFENCE |
| Address |
ARMY DENTAL CENTRE RESEARCH AND REFERRAL
NEW DELHI
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SARAVANAN SP |
ARMY HOSPITAL DELHI |
ROOM NO C, FIRST FLOOR, DEPT OF PERIODONTOLOGY, ARMY DENTAL CENTRE RESEARCH AND REFERRAL
NEW DELHI
South
DELHI |
9637110906
drsaravanan.sp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMY DENTAL CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, (2) ICD-10 Condition: L438||Other lichen planus, (3) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LASER PATTERNED MICROCOAGULATION THERAPY |
LASER PATTERNED MICROCOAGULATION THERAPY USING DIODE LASER AT 690 NM WAVELENGTH AND 0.5WATTS POWER IN PULSED NON CONTACT MODE FOR 80 MILLISECONDS. The total duration of intervention will be for 4 weeks at weekly intervals ( 1 time / week for 4 weeks) |
| Comparator Agent |
TOPICAL STEROIDS |
PATIENTS WHO ARE ALREADY ON TOPICAL STEROID WITH 0.1% TRIAMCINALONE ACETONIDE FOR MINIMUM 30 DAYS UPTO 90 DAYS DURATION. The total duration will be 6 months. Comparison will be made at baseline, 3 months, 6 months. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with oral lichen planus
Presenting with desquamative gingival lesions alone
Not on any other topical or systemic medication for the same Systemically no other comorbid conditions
|
|
| ExclusionCriteria |
| Details |
Patients exhibiting dermatologic manifestations
Unwilling for laser therapy
Pregnancy
Lactation
Recent history of steroid use within 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oral health quality of life
Numerical rating scale for pain
Photometric reduction of desquamated areas |
Baseline, 03 months, 06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number needed to treat with topical or systemic steroids |
Baseline, 03 months and 06 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2022 |
| Date of Study Completion (India) |
01/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/08/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
One of the most difficult circumstances for a periodontist is the care of problems related with desquamative gingival lesions. These individuals are typically handled with topical/systemic drugs. The introduction of LASER technology has revolutionized the management of such difficult-to-control clinical scenarios. Objective The purpose of this pilot study is to evaluate the effectiveness of a novel LASER regimen, ‘LPM PROTOCOL’ in the treatment of gingival desquamative lesions. The goals are to evaluate clinical improvement and numbers needed to treat (NNT) with topical and/or systemic steroids. Methodology Ten patients with chronic desquamative gingivitis related to Oral Lichen Planus will be treated with LPM PROTOCOL. Treatment will be delivered in four sittings and followed for 06 months. All the clinical parameters will be recorded at baseline, 03 months, 06 months. |