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CTRI Number  CTRI/2019/05/019057 [Registered on: 10/05/2019] Trial Registered Prospectively
Last Modified On: 15/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Laser assisted non-surgical therapy for treating gum disease  
Scientific Title of Study   Evaluation Of Combined Efficacy Of Photodynamic Therapy and non-surgical periodontal therapy on Clinical and Microbial parameters in the management of chronic periodontitis subjects; Randomized Controlled Clinical Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kanchana sukumar 
Designation  Post Graduate 
Affiliation  SRM Dental College  
Address  Department of Periodontics and Oral Implantology

Thiruvallur
TAMIL NADU
600089
India 
Phone  91-9500166475  
Fax    
Email  kancha1308@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anupama Tadepalli 
Designation  Reader 
Affiliation  SRM Dental College  
Address  SRM Dental College, Ramapuram Department of Periodontics and Oral Implantology room no: 4

Chennai
TAMIL NADU
600089
India 
Phone  91-9677065517  
Fax    
Email  anupamamds@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kanchana sukumar 
Designation  Post Graduate 
Affiliation  SRM Dental College  
Address  Department of Periodontics and Oral Implantology

Chennai
TAMIL NADU
600089
India 
Phone  91-9500166475  
Fax    
Email  kancha1308@gmail.com  
 
Source of Monetary or Material Support  
Institution - SRM Dental Hospitals self-funded study  
Self - funded S.Kanchana 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [self funded] 
 
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 
Kanchana  SRM Dental College & Hospitals, Ramapuram  Department of Periodontics and Oral Implantology
Chennai
TAMIL NADU 		 9500166475

kancha1308@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board SRM Dental College  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  indocyanine green dye of 1mg/ml concentration will be irrigated into the periodontal sulcus using blunt needle and irradiated using 810 nm diode laser of 0.8 W for 30 seconds  
Comparator Agent  Scaling and root planing   scaling and root planing done using curettes  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  44.00 Year(s)
Gender  Both 
Details  1) Patients Aged 35 - 44 years
2) AAP 1999 criteria will be followed for diagnosis of chronic periodontitis patients
3) Patient having with bilateral periodontal destruction in mandibular posterior segment (involving minimum 3 teeth).
4) Periodontal destruction manifesting in form of moderate periodontal pockets (5-6mm) with clinical attachment loss.
 
 
ExclusionCriteria 
Details  1) Smokers
2) Pregnancy or use of hormone contraceptives
3) Systemic condition / disease/ any medication having influence on the course of periodontal disease and therapy
4) Patients with history of use of antibiotics within the last 6 months and use of anti-inflammatory drugs within the last 3 months
5) Patients with history of periodontal treatment in the last year
6) Sites with gingival recession / pseudo periodontal pockets / advanced periodontal destruction with intra bony defects/ mobility
7) Teeth with restorations, endodontic lesions
8) Patients who are known hypersensitive for PDT dye
9) Patients contraindicated for laser intervention
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
clinical parameters:
1.Probing Pocket Depth
2.Clinical Attachment Loss 		 baseline, 3 months, 6months 
 
Secondary Outcome  
Outcome  TimePoints 
Microflora in subgingival plaque samples  Baseline and 6 months
 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2019 
Date of Study Completion (India) 15/11/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
Title:  Evaluation of Combined Efficacy of Photodynamic Therapy and Non-Surgical Periodontal Therapy On Clinical and Microbial Parameters In The Management Of Chronic Periodontitis Subjects-Randomized Controlled Clinical Trial 


In this observational study we propose to assess the improvement in clinical and microbial parameters after multiple application of Photodynamic Therapy (PDT) using Indocyanine Green (ICG) and Diode Laser (810 nm) as an adjunct to non- surgical periodontal therapy in moderate periodontal pockets for a period of 6 months. If the multiple application of PDT is proven to be effective it can be recommended as a regular treatment protocol in order to avoid invasive surgical procedures.
 
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