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CTRI Number  CTRI/2023/02/049678 [Registered on: 13/02/2023] Trial Registered Prospectively
Last Modified On: 24/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Other 
Public Title of Study   Application of LASER along with Indocyanine Green dye as an adjunct to mechanical debridement for treatment of periodontal disease in periodontal maintenance patients. 
Scientific Title of Study   Indocyanine Green based antimicrobial Photodynamic Therapy as an adjunct to non-surgical periodontal treatment in periodontal maintenance patients: A clinico-microbiological study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Urbashi Roy Chowdhury 
Designation  Post graduate (MDS) 
Affiliation  Manipal College of Dental Sciences, Manipal academy of higher education, Mangalore 
Address  Room no.4, Department of periodontology, Manipal college of dental sciences, Lighthouse hill road, hampankatta, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  7980584610  
Fax    
Email  urjoey810@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepa G Kamath 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences, Manipal academy of higher education, Mangalore 
Address  Room No.4, Department of periodontology, Manipal college of dental sciences, Lighthouse hill road, hampankatta, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9448454788  
Fax    
Email  deepa.gkamath@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Urbashi Roy Chowdhury 
Designation  Post graduate (MDS) 
Affiliation  Manipal College of Dental Sciences, Manipal academy of higher education, Mangalore 
Address  Room no.4, Department of periodontology, Manipal college of dental sciences, Lighthouse hill road, hampankatta, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  7980584610  
Fax    
Email  urjoey810@gmail.com  
 
Source of Monetary or Material Support  
Room no 4, Department of periodontology, Manipal College of Dental Sciences, Manipal Academy of Higher Education, Light House Hill Road, Mangalore  
 
Primary Sponsor  
Name  Manipal College Of Dental Sciences, Mangalore 
Address  room no 4.LIGHT HOUSE HILL ROAD MANIPAL COLLEGE OF DENTAL SCIENCES,MANIPAL ACADEMY OF HIGHER EDUCATION MANGALORE-575001 
Type of Sponsor  Research institution and hospital 
 
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 
Urbashi Roy Chowdhury  Manipal college of dental sciences,Mangalore  Room no:4,Department of Periodontology, Lighthouse Hill Road
Dakshina Kannada
KARNATAKA 		 7980584610

urjoey810@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Manipal College of Dental Sciences,Mangaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Indocyanine green dye(Aurogreen®, Aurolabs, Madurai, India,1mg/ml) photodynamic therapy as adjunct to Scaling and root planing   Patients will be given Indocyanine green (ICG) based photodynamic therapy(PDT) along with scaling and root planing. Photosensitizer - ICG 5 mg/mL applied at the base of pockets LASER system- Diode laser (Picasso AMD) of wavelength of 810 nm,applied in a continuous mode, circumferentially around the tooth, with a power of 2 W for 60 s. Total energy produced is 6J/cm2.  
Comparator Agent  Indocyanine green Placebo as adjunct to Scaling and root planing  Patients enrolled in periodontal maintenance therapy having residual pockets will be subjected to Scaling and root planing. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients who agree to participate in the study by signing the informed consent.
Age ≥ 30 years irrespective of gender.
Patients diagnosed with stage II and stage III periodontitis having completed active periodontal treatment atleast 3-6 months prior, receiving regularly supportive periodontal therapy (SPT) and exhibiting residual pockets of ≥4mm.
Systemically healthy controls
Full Mouth Plaque Score 25%
Full Mouth Bleeding Score 25%
 
 
ExclusionCriteria 
Details  1. Patients with systemically compromised health like diabetes, that may influence the periodontal status.
2. Use of drugs such as immune-suppressants, anti-epileptic, calcium antagonist
3. Use of antimicrobial mouthrinses in the preceding 2 months
4. Smokers
5. Use of systemic antibiotics in the last twelve months
6. Restorations and superficial caries in the area to be treated.
7. History of allergy of any kind of dye or iodine.
8. Pregnant or lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
changes in probing pocket depth and clinical attachment level  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary objective was to compare the changes in detection frequency of Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans and Tannerella forsythia, Fusobacterium nucleatum, in subgingival plaque samples of test and control sites before and after therapy.  3 months 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="25" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2023 
Date of Study Completion (India) 31/05/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/05/2023 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 not published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 The randomised split mouth study comprises of 2 groups diagnosed with periodontitis, enrolled in maintenance program having residual pockets, wherein one group receives only scaling and root planing and the other group receives scaling and root planing along with Indocyanine green based photodynamic therapy. The patients will be recalled after 3 months for assessment of clinical and microbiological parameters. 
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