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CTRI Number  CTRI/2020/04/024492 [Registered on: 07/04/2020] Trial Registered Prospectively
Last Modified On: 25/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of Chlorhexidine varnish application with Scaling-Root Planing and Scaling-Root Planing alone in patients with gum disease. 
Scientific Title of Study   Comparative clinical evaluation of 1% chlorhexidine and thymol varnish application with Scaling-Root Planing and Scaling-Root Planing alone in patients with chronic periodontitis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shefali Malik 
Designation  Post Graduate Student 
Affiliation  Sudha Rustagi College Of Dental Sciences 
Address  Department of Periodontology Third Floor, Room No.-8 Sector-89, Kheri More, Faridabad, Haryana 121002

Faridabad
HARYANA
121002
India 
Phone  9821846050  
Fax    
Email  shefalimalik27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr C S Baiju 
Designation  Professor  
Affiliation  Sudha Rustagi College of Dental Science and Research 
Address  Department of Periodontology Sudha Rustagi College of Dental Science and Research Kheri More Sector-89

Faridabad
HARYANA
121002
India 
Phone  9810336864  
Fax    
Email  drcsbaiju@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr C S Baiju 
Designation  Professor  
Affiliation  Sudha Rustagi College of Dental Science and Research 
Address  Department of Periodontology Sudha Rustagi College of Dental Science and Research Kheri More Sector-89

Yamunanagar
HARYANA
121002
India 
Phone  9810336864  
Fax    
Email  drcsbaiju@yahoo.co.in  
 
Source of Monetary or Material Support  
Sudha Rustagi College of Dental Sciences and Research , Sector-89, Faridabad, Haryana 121002 
 
Primary Sponsor  
Name  Shefali Malik 
Address  Department of Periodontology Third Floor, Room No.-8 Sudha Rustagi College Of Dental Sciences and Research Sector-89, Kheri More, Faridabad, Haryana 121002 
Type of Sponsor  Other [PRIVATE DENTAL COLLEGE] 
 
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 
Shefali Malik  Sudha Rustagi College of Dental Science and Research  Department Of Periodontology Third Floor, Room No.- 8 Sector-89,Kheri More 121002
Faridabad
HARYANA 		 9821846050
4230010
shefalimalik27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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 
Comparator Agent  1% chlorhexidine and thymol varnish  To evaluate the efficacy of 1% chlorhexidine and thymol varnish with scaling-root planing and scaling-root planing alone in patients with chronic periodontitis 
Intervention  Phase-1 Non Surgical Periodontal Therapy  Scaling is the process by which biofilm and calculus are removed from both supragingival and subgingival tooth surfaces. No deliberate attempt is made to remove tooth substance along with the calculus. Root planing is the process by which residual embedded calculus and portions of cementum are removed from the roots to produce a smooth,hard,clean surface 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The presence of more than or equal to 20 teeth with third molars excluded is a prerequisite for enrollment. Subjects with moderate to severe chronic periodontitis with atleast one pocket per quadrant having a probing pocket depth between 5mm-6mm and CAL more than or equal to 3mm, with no contraindication to periodontal therapy, no history of allergy to chlorhexidine and thymol and with no history of use of any active medicated oral hygiene preparation, were included in the study. 
 
ExclusionCriteria 
Details  Patients would be required to not have received any periodontal and antibiotic therapy in the last 6 months and are to be cooperative and committed to maintain oral hygiene. Patients wearing removable partial partial dentures or undergoing orthodontic therapy will be excluded. Sites neighboring recent extraction sockets will be excluded. Patients who are smokers, tobacco, and alcohol abusers, with any systemic illness, pregnant and lactating females, using an antimicrobial mouthwash in the past 2 months, and those requiring periodontal surgery and those with teeth having any pulpal/periapical pathology will be excluded from the study. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To investigate the effectiveness of commercially available 1% Chlorhexidine and thymol varnish applied subgingivally as an adjunct to Scaling-Root planing on clinical periodontal parameters and compare it to Scaling-Root planing alone in chronic periodontitis patients  1 month and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the clinical periodontal parameters in both the groups after 1 month and 3 months  1 month and 3 months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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   Phase 1 
Date of First Enrollment (India)   20/04/2020 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The primary motive of this study is to compare results of periodontal treatment of comnmercially available 1% chlorhexidine and thymol varnish application with Scaling-Root planing and Scaling-Root Planing alone in patients with chronic periodontitis.
 
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