| CTRI Number |
CTRI/2025/07/092009 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Two different methods are used in the treatment of patients with gum disease, such as laser biostimulation in one group and LED photoactivation using a dye like methylene blue in another group and reduction in disease severity will be assessed after 2 months |
|
Scientific Title of Study
|
Comparative evaluation of Laser Biostimulation and LED Photoactivation using Methylene Blue in the Treatment of Periodontitis:
A split-mouth randomized controlled 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 Poojitha Koppada |
| Designation |
Post Graduation Student |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
GITAM Dental College and Hospital Department of periodontics Room number 6 Gandhinagar Campus Rushikonda
Visakhapatnam
ANDHRA PRADESH
530045
India
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
8919797776 |
| Fax |
|
| Email |
pujithapooja95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P TANUJA |
| Designation |
Professor |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
GITAM Dental College and Hospital Department of periodontics Room number 6 Gandhinagar Campus Rushikonda Visakhapatnam
ANDHRA PRADESH
530045
India
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9441313131 |
| Fax |
|
| Email |
drtanujap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poojitha Koppada |
| Designation |
Post Graduation Student |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
GITAM Dental College and Hospital Department of periodontics Room number 6 Gandhinagar Campus Rushikonda
Visakhapatnam
ANDHRA PRADESH
530045
India
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
8919797776 |
| Fax |
|
| Email |
pujithapooja95@gmail.com |
|
|
Source of Monetary or Material Support
|
| GITAM Dental College and Hospital
Department of periodontics
room number 6
Gandhinagar
Rushikonda
Visakhapatnam
Andhrapradesh
530045 |
|
|
Primary Sponsor
|
| Name |
Dr Poojitha Koppada |
| Address |
GITAM Dental College and Hospital Department of periodontics
room number 6
Gandhinagar
Rushikonda
Visakhapatnam
Andhrapradesh
530045 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Poojitha Koppada |
GITAM Dental College and Hospital |
GITAM Dental College and Hospital Department of periodontics Room number 6 Gandhinagar Campus Rushikonda
Visakhapatnam
ANDHRA PRADESH
530045
India
Visakhapatnam
ANDHRA PRADESH |
08919797776
pujithapooja95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GITAM Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LASER biostimulation adjunct to scaling and root planing
Duration is 2 months |
Evaluation and comparison of clinical parameters such as Bleeding on probing, plaque index , probing pocket depth and clinical attachment loss at baseline and at 2 months post-operatively. |
| Comparator Agent |
LED photoactivation using methylene blue adjunct to scaling and root planing
Duration is 2 months |
Evaluation and comparison of clinical parameters such as bleeding on probing, plaque index , probing pocket depth and clinical attachment loss at baseline and at 2 months post-operatively |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with the age group between 25 – 55 years old
Subjects with stage II periodontitis 5mm
Systemically healthy subjects
Subjects with good compliance |
|
| ExclusionCriteria |
| Details |
Subjects with systemic diseases and conditions
Subjects who underwent periodontal treatment within 6 months prior to the study
Smokers and tobacco users
Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Probing pocket depth
Clinical attachment loss at 2 months
|
To evaluate and compare Probing pocket depth and Clinical attachment loss 2 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque index
Bleeding on probing at 2 months |
To evaluate compare plaque index bleeding on probing at 2 months postoperatively |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
25/08/2025 |
| 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="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
|
The title of the study is Comparative evaluation of LASER biostimulation and LED photoactivation using methylene blue in the treatment of periodontitis A split mouth randomized controlled trial. A total of 112 sites from periodontitis patients satisfying the inclusion and exclusion criteria and providing consent for study participation will be selected and split into two groups. Group 1 will be allocated with 56 sites and will be receiving Laser biostimulation adjunct to scaling and root planing with the biostimulation at 1st,15th,30th and 45th day. Group 2 with 56 sites and will be receiving LED photoactivation using methylene blue adjunct to scaling and root planing with the activation at 1st,15th,30th and 45th day. The clinical parameters such as Bleeding on probing, Plaque index, Probing pocket depth and clinical attachment loss will be evaluated and compared in both the groups pre operatively and 2 months post operatively. |