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CTRI Number  CTRI/2024/09/073681 [Registered on: 10/09/2024] Trial Registered Prospectively
Last Modified On: 10/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing the use of methylene blue and indocyanine green dyes in photodynamic therapy for the treatment of moderate periodontitis patients. 
Scientific Title of Study   Comparative evaluation of antimicrobial effect of indocyanine green and methylene blue dye as photosensitizers for photodynamic therapy as an adjunct to scaling and root planing in patients with moderate 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 Jasleen Thakker 
Designation  Post-graduate 
Affiliation  KAHERs KLE V.K Institute of Dental Sciences 
Address  Room no.9, Department of Periodontics, KAHERs KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi, Karnataka, India 590010

Belgaum
KARNATAKA
590010
India 
Phone  7506367111  
Fax    
Email  jasangle11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vilas Pattar 
Designation  Reader 
Affiliation  KAHERs KLE V.K Institute of Dental Sciences 
Address  Room no.9, Department of Periodontics, KAHERs KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi, Karnataka, India 590010

Belgaum
KARNATAKA
590010
India 
Phone  9886597561  
Fax    
Email  vilspat83@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jasleen Thakker 
Designation  Post-graduate 
Affiliation  KAHERs KLE V.K Institute of Dental Sciences 
Address  Room no.9, Department of Periodontics, KAHERs KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi, Karnataka, India 590010


KARNATAKA
590010
India 
Phone  7506367111  
Fax    
Email  jasangle11@gmail.com  
 
Source of Monetary or Material Support  
KAHERs KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi, Karnataka, India 590010 
 
Primary Sponsor  
Name  Dr Jasleen Thakker 
Address  KAHERs KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi, Karnataka, India 590010 
Type of Sponsor  Other [Self sponsored] 
 
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 Jasleen  KAHERs KLE V.K Institute of Dental Sciences  Room no.9, Department of Periodontics, KAHERs KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi, Karnataka, India 590010
Belgaum
KARNATAKA 
7506367111

jasangle11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  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  0.5% Indocyanine green dye  Assessing the antimicrobial efficacy of photodynamic therapy with 0.5% Indocyanine green dye as an adjunct to scaling and root planing. 
Intervention  1% Methylene blue dye  Assessing the antimicrobial efficacy of photodynamic therapy with 1% Methylene blue dye as an adjunct to scaling and root planing 
Comparator Agent  Scaling and root planing  Patients will receive full mouth scaling and root planing under local anesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Non smoking adults more than 18 years of age
Patients with minimum 20 teeth present
Untreated moderate periodontitis with probing depth more than or equal to 5mm & less than 7mm, presence of bleeding on probing and clinical attachment loss of 3mm to 4mm.
Signed informed consent
 
 
ExclusionCriteria 
Details  Pregnant or lactating women.
Periodontal treatment in the past 6 months.
Patients allergic to the use of dyes.
Patients presenting with a history of ocular problems.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Gingival index, Pocket probing depth, Clinical attachment loss  Baseline, 1 week, 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Colony forming units/ml  Baseline, 1 week, 1 month 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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   N/A 
Date of First Enrollment (India)   26/09/2024 
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="1"
Months="0"
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  

Ø  The primary goal of periodontal therapy is to eliminate bacterial biofilm and endotoxins from root surfaces of the teeth. However, owing to anatomical variations in root surfaces, complex furcation areas, concavities on root surfaces, and bacterial invasion of the surrounding soft tissues, nonsurgical periodontal therapy (NSPT) alone cannot eliminate periodontal pathogens.1

Ø  Although systemic and local administration of antibiotics into periodontal pockets may be effective for disinfection, the frequent usage of antibiotics bears the potential risk of producing resistant microorganisms.1

Ø  In recent years, photodynamic therapy (PDT) with the help of lasers has been used to decontaminate the pocket environment as it is a minimally invasive treatment that activates the immune system, has low systemic toxicity, and possesses high bactericidal properties. The eradication of tissue invasive microorganisms associated with periodontitis and peri-implantitis by lasers has been amply demonstrated.2

Ø  Combining lasers and photosensitizing agents can result in photo destruction of target cells due to cytotoxic effect in the presence of oxygen. This light-induced effect is due to the conversion of the excited photosensitizer from the ground state to the triplet state resulting in production of singlet oxygen and other reactive agents, which are very toxic to certain cells or bacteria.3

Ø  A recent in vitro study had shown the efficacy of a new photosensitizer dye, indocyanine green (ICG), against Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis, when activated at a wavelength of 810 nm by a diode laser. It has high absorption in the infrared spectrum, low toxicity, and rapid elimination.4

Ø  Methylene blue has a strong absorption band in the 550-700 nm region and has been extensively used for photooxidation of natural and synthetic molecules. Fontana et al, in 2009, demonstrated aPDT with 25 μg/mL methylene blue and red light resulted in 63% reduction of planktonic bacteria and 32% decrease in bacteria forming biofilms.5

Ø  The photokilling rate in antimicrobial photodynamic therapy is highly related to interaction of reactive oxygen species (ROS) produced, ability of photosensitizers (PS) in incorporating into microorganisms and light devices/microorganism type.6

Ø  While methylene blue and indocyanine green are present in the dental practice as PS there is an acute paucity of literature comparing their efficacy in terms of improvement of clinical parameters and suppression of periodontal pathogens. Therefore, the present study aims at comparative evaluation of antimicrobial effect of indocyanine green and methylene blue dye as photosensitizers for photodynamic therapy as an adjunct to scaling and root planing in patients with moderate periodontitis.                         

 
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