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CTRI Number  CTRI/2024/05/066702 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 01/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   laser therapy 
Scientific Title of Study   Comparison of efficacy of Phthalocyanine (Pc) and Methylene blue (MB) as photosensitizers in Photodynamic Therapy as an adjunct to Scaling and Root Planing in Chronic Periodontitis A Clinical and Microbiological study 
Trial Acronym  PDT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Drsuryakanth malgikar 
Designation  Associate Professor 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Kamineni Institute of Dental Sciences, Department of Periodontics, Room number 6, First Floor Sreepuram, Narketpally - Nalgonda
Kamineni Institute of Dental Sciences,Department of Periodontics, Room number 6, First Floor Sreepuram, Narketpally
Nalgonda
TELANGANA
508254
India 
Phone  9591212165  
Fax  08682272296  
Email  drmalgikarsuryakanth@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Drsuryakanth malgikar 
Designation  Associate Professor 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Kamineni Institute of Dental Sciences,Department of Periodontics, Room number 6, First Floor Sreepuram, Narketpally Nalgonda (Dist.)
Kamineni Institute of Dental Sciences, Department of Periodontics, Room number 6, First Floor Sreepuram, Narketpally Telangana.
Nalgonda
TELANGANA
508254
India 
Phone  9591212165  
Fax  08682272296  
Email  drmalgikarsuryakanth@gmail.com  
 
Details of Contact Person
Public Query  
Name  Drsuryakanth malgikar 
Designation  Associate Professor 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Kamineni Institute of Dental Sciences,Department of Periodontics, Room number 6, First Floor Sreepuram, Narketpally - Nalgonda (Dist.)
Kamineni Institute of Dental Sciences,Department of Periodontics, Room number 6, First Floor Sreepuram, Narketpally
Nalgonda
TELANGANA
508254
India 
Phone  9591212165  
Fax  08682272296  
Email  drmalgikarsuryakanth@gmail.com  
 
Source of Monetary or Material Support  
Kamineni Institute of Dental Sciences,Department of Periodontics, Room number 6, First Floor Sreepuram, Narketpally - Nalgonda (Dist.) - 508254 Telangana, India 
 
Primary Sponsor  
Name  DrSuryakanth Malgikar 
Address  Kamineni Institute of Dental Sciences, Sreepuram, Narketpally - 508 254, Nalgonda (Dist.) Telangana.  
Type of Sponsor  Other [Self] 
 
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 
Drsuryakanth Malgikar  Kamineni Institute of Dental Sciences  Department of Periodontics, Room number 6, First Floor Sreepuram, Narketpally - 508254
Nalgonda
TELANGANA 		 9591212165
08682272296
drmalgikarsuryakanth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kamineni institute of dental sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  chronic periodontitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Photodynamic Therapy and Scaling and Root Planing   Photodynamic Therapy as an adjunct to Scaling and Root Planing  
Comparator Agent  photosensitizers  Phthalocyanine (Pc) and Methylene blue (MB) as photosensitizers in Photodynamic Therapy  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. At least 20 teeth present
2. Bleeding on probing
3. Chronic periodontitis stage 2 and 3 with grade B
4. Periodontal Pocket Depth ≥ 5mm
 
 
ExclusionCriteria 
Details  1. Systemically compromised patients and those on medications that may interfere with wound healing.
2. Pregnant women and lactating mother.
3. Smokers
4. Active periodontal treatment within the last 6 months
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Probing Pocket Depth (PPD)
Clinical Attachment Level (CAL)
 		 baseline, 4 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
microbiological outcome  baseline 1 month 3 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   27/05/2024 
Date of Study Completion (India) 01/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/04/2025 
Estimated Duration of Trial   Years="1"
Months="1"
Days="20" 
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
Modification(s)  

The present study is designed to compare the efficacy of two different photosensitizers Phthalocyanine (Pc) and Methylene Blue (MB) in Photodynamic therapy on to reduce the viability of gram-positive and gram-negative pathogens.

MATERIALS AND METHODS:

SOURCE OF DATA: 

Subjects with chronic periodontitis aged 18-60 years will be selected from the outpatient department of periodontics, kamineni institute of dental sciences.

INCLUSION CRITERIA:

1.      Age group 18-60 years.

2.      At least 20 teeth present

3.      Bleeding on probing

4.      Chronic periodontitis stage 2 and 3 with grade B

5.      Periodontal Pocket Depth ≥ 5mm.

EXCLUSION CRITERIA:

1.      Systemically compromised patients and those on medications that may interfere with wound healing.

2.      Pregnant women and lactating mother.

3.      Smokers

4.      Active periodontal treatment within the last 6 months

SAMPLE SIZE: The study consists of 30 subjects which will be randomly assigned (ten in each) into three groups.

Group I:  Scaling and root planing (SRP)

Group II: SRP and PDT with phthalocyanine blue (Pc)

Group III: SRP and PDT with 1% methylene blue

CLINICAL PARAMETERS

The following parameters will be assessed at Baseline and after 1 Month.

1.      Plaque index (PI)

2.      Bleeding on probing (BOP)

3.      Probing Pocket Depth (PPD)

4.      Clinical Attachment Level (CAL)

The probing pocket depth and CAL will be measured using a UNC-15 graduated periodontal probe.

MICROBIOLOGICAL PARAMETERS

Subgingival plaque samples will be collected at baseline and at the end of 1 month in a transport media (Saline 0.9%) for estimating the presence of gram-positive and gram-negative pathogens at Kamineni Institute of Medical Sciences, Narketpally.
 
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