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CTRI Number  CTRI/2025/11/098095 [Registered on: 26/11/2025] Trial Registered Prospectively
Last Modified On: 01/07/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A Study To Evaluate Indocyanine Green Dye With Laser In Treating Gum Disease 
Scientific Title of Study   Evaluation Of Indocyanine Green-Mediated Photodynamic Therapy As An Adjunct To Scaling And Root Planing In The Treatment Of Periodontitis: A 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 Libujaa Baji 
Designation  MDS Post Graduate Student 
Affiliation  Vokkaligara Sangha Dental College and Hospital 
Address  Department of Periodontics, Vokkaligara Sangha Dental College and Hospital, Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004

Bangalore
KARNATAKA
560004
India 
Phone  9703465333  
Fax    
Email  libujaarohi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajiv N P 
Designation  Professor and Guide 
Affiliation  Vokkaligara Sangha Dental College and Hospital 
Address  Department of Periodontics, Vokkaligara Sangha Dental College and Hospital, Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004

Bangalore
KARNATAKA
560004
India 
Phone  9980111426  
Fax    
Email  rajivnidasale@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajiv N P 
Designation  Professor and Guide 
Affiliation  Vokkaligara Sangha Dental College and Hospital 
Address  Department of Periodontics, Vokkaligara Sangha Dental College and Hospital, Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004

Bangalore
KARNATAKA
560004
India 
Phone  9980111426  
Fax    
Email  rajivnidasale@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Libujaa Baji 
Address  Department of Periodontics, Vokkaligara Sangha Dental College and Hospital, Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004 
Type of Sponsor  Other [Private Dental College] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Libujaa Baji  Room number 5, Department of Periodontics, Vokkaligara Sangha Dental College And Hospital  Room number 5, Department of Periodontics, Vokkaligara Sangha Dental College And Hospital, Krishna Rajendra Road, next to KIMS Hospital, Parvathipuram, Visvesvarapuram, Basavanagudi, Bengaluru, Karnataka 560004
Bangalore
KARNATAKA 		 9703465333

libujaarohi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KIMS Instituitional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically healthy human volunteers with periodontitis  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Scaling and Root planing  The control sites will receive Scaling and Root Planing alone.  
Intervention  Scaling and Root Planing followed by Indocyanine Green-Mediated Photodynamic Therapy.  The test sites will be treated with Scaling and Root Planing (SRP) combined with indocyanine green-mediated photodynamic therapy (ICG-PDT). For photodynamic therapy, indocyanine green (ICG) will be delivered into the periodontal pocket using a blunt needle. After 2 minutes, the pocket will be thoroughly rinsed with sterile water to remove excess photosensitizer. Immediately after rinsing, an 810 nm diode laser with a 0.5 W power output in continuous mode, using an optic fiber tip of 400 micrometer diameter, will be placed in non-contact mode, 1 mm coronal to the pocket depth and moved in a sweeping motion for 1 minute. It is a single session intervention. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Presence of one or more periodontal pockets, as classified under Stage II or Stage III
periodontitis, in at least two quadrants of the mouth.
2. Systemically healthy patients.
3. Patients who have provided written informed consent. 
 
ExclusionCriteria 
Details  1. Pregnant and lactating women.
2. Patients with the habit of smoking or tobacco chewing.
3. Patients who underwent periodontal therapy in the past 6 months.
4. Patients who underwent antibiotic therapy in the past 3 months.
5. History of allergy to iodine.
6. Patients with history of bleeding disorders. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical measurements- Plaque Index, Gingival Index, Gingival bleeding index, Probing pocket depth, Relative attachment level.
Microbiological monitoring- Quantifying of Porphyromonas gingivalis in sub gingival plaque samples 		 Baseline, 1 month, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/12/2025 
Date of Study Completion (India) 10/09/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 randomized split-mouth controlled trial evaluating Indocyanine Green-Mediated Photodynamic Therapy (ICG-PDT) as an adjunct to Scaling and Root Planing (SRP) in treating Stage II/III periodontitis patients. Twelve patients will receive SRP at control sites and SRP followed by ICG-PDT at test sites. Clinical parameters such as Plaque Index, Gingival Index, Gingival Bleeding Index, Probing Pocket Depth, Relative Attachment Level and Quantification of Porphyromonas gingivalis in sub-gingival plaque samples assessed by real-time PCR will be recorded at baseline, 1 month, and 3 months.

 
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