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CTRI Number  CTRI/2025/03/083028 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A clinico-microbial study comparing the effectiveness of antimicrobial photodynamic therapy mediated by indocyanine green and methylene blue as an adjunct to non surgical periodontal therapy 
Scientific Title of Study   "COMPARATIVE EVALUATION OF EFFICACY OF INDOCYANINE GREEN AND METHYLENE BLUE MEDIATED ANTIMICROBIAL PHOTODYNAMIC THERAPY AS AN ADJUNCT TO NON-SURGICAL TREATMENT OF PERIODONTITIS. A CLINICO-MICROBIAL STUDY”  
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 K SUNEETHA 
Designation  PROFESSOR 
Affiliation  Drs. Sudha and Nageswara rao Siddartha institute of dental sciences 
Address  Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli gannavaram mandal krishna district

Krishna
ANDHRA PRADESH
521286
India 
Phone  9290574051  
Fax    
Email  ksuneetha@sids.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr K SUNEETHA 
Designation  PROFESSOR 
Affiliation  Drs. Sudha and Nageswara rao Siddartha institute of dental sciences 
Address  Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli gannavaram mandal krishna district

Krishna
ANDHRA PRADESH
521286
India 
Phone  9290574051  
Fax    
Email  ksuneetha@sids.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr K SUNEETHA 
Designation  PROFESSOR 
Affiliation  Drs. Sudha and Nageswara rao Siddartha institute of dental sciences 
Address  Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli gannavaram mandal krishna district

Krishna
ANDHRA PRADESH
521286
India 
Phone  9290574051  
Fax    
Email  ksuneetha@sids.edu.in  
 
Source of Monetary or Material Support  
This study will be carried out in department of periodontics and implantology of Dr. Sudha and Nageswara rao Siddartha Institute of dental sciences Chinnaoutapalli Gannavaram mandal Krishna district PINCODE: 521286 Andhra Pradesh India  
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [] 
 
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 
Dr Mounasri P  Drs. sudha and nageswararao siddartha institute of dental scinences  Department of periodontics and implantology room no. 3
Krishna
ANDHRA PRADESH 
7386862468

mounasriprathipati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Drs Sudha and Nageswara rao siddartha institute of dental sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Indocyanine green  Photosensitizing agent 
Comparator Agent  Methylene Blue  Photosensitizing agent 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients with minimum 20 teeth.
Patients with Stage II Grade A periodontitis having at least 3 teeth with probing depth of 5 mm.
 
 
ExclusionCriteria 
Details  Consumption of tobacco in any form.
Pregnant and lactating women.
Patients taking medications that may interfere with periodontal therapy.
Previous history of allergic reaction to the use of any kind of dye.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque index
Gingival index
Probing pocket depth
Clinical attachment level 
At baseline, 1 and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Microbial analysis of total viable anaerobic count (TVAC)  At baseline, 1 and 3 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/04/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Photodynamic therapy (PDT) is an oxygen dependent photochemical reaction that occur upon light mediated activation of a photosensitizing compound leading to generation of cytotoxic reactive oxygen species.PDT has emerged in recent years as a non-invasive therapeutic option.Many photosensitizers like methylene blue, toluidine blue has proven to be effective. But certain disadvantages linked to these agents, such as, incidental staining, need to purchase of separate laser units etc., establish the need for a potential new photosensitizer transcending these disadvantages.A Food and Drug Administration (FDA) dye, Indocyanine green (ICG) was used in hepatic function diagnostics, fluorescent angiography in ophthalmology and later in cardiology had become established as new in dentistry.A new photosensitizer called indocyanine green (ICG) has been developed which gets activated upon absorbing light of specific wavelength. The fact that ICG does not require oxygen can make it even more effective in anaerobic subgingival area as compared to other photosensitizers and used for the treatment of periodontitis.The disadvantages of earlier dyes, better efficiency and safety with ICG and successful in vitro studies using this dye against periopathogenic bacteria, led to present studies.

Not many studies have been conducted using ICG dye to study effect of aPDT in periodontitis.Not many studies have been conducted to compare the clinical and microbial efficacy between ICG and methylene blue.

The present study helps to evaluate the clinical and microbiological effects of ICG mediated aPDT as an adjunct to non-surgical management of chronic periodontitis.

And to evaluate and compare the clinical and microbiological effects between ICG(1mg/ml) and Methylene blue (1%) using low power diode laser (0.8W, 940nm) in the management of chronic periodontitis.  
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