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CTRI Number  CTRI/2024/08/072051 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 31/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparision between two solutions for reducing the bacterial count in root canal of primary teeth. 
Scientific Title of Study   Comparative evaluation of antibacterial efficacy of 2 percent Chlorhexidine and 6 percent Chitosan as irrigating solutions in nonvital primary teeth An invivo 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 Shere Shraddha Vivekanand 
Designation  Post Graduate MDS Student 
Affiliation  NIMS University 
Address  Department no. 7, NIMS Dental College and Hospital, NIMS University, Jaipur

Jaipur
RAJASTHAN
303121
India 
Phone  7745073955  
Fax    
Email  shereshraddha96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Chaya Chhabra 
Designation  MDS, HOD, Guide 
Affiliation  NIMS University 
Address  Department no. 7, NIMS Dental College and Hospital, NIMS University, Jaipur

Jaipur
RAJASTHAN
303121
India 
Phone  7745073955  
Fax    
Email  chaya.chhabra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shere Shraddha Vivekanand 
Designation  Post Graduate MDS Student 
Affiliation  NIMS University 
Address  Department no. 7, NIMS Dental College and Hospital, NIMS University, Jaipur

Jaipur
RAJASTHAN
303121
India 
Phone  7745073955  
Fax    
Email  shereshraddha96@gmail.com  
 
Source of Monetary or Material Support  
NIMS Dental College and Hospital, Jaipur, Rajasthan, India - 303121 
 
Primary Sponsor  
Name  Dr Shere Shraddha Vivekanand 
Address  NIMS Dental College and Hospital, NIMS University, Jaipur, Rajasthan 303121 
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 
Dr Shere Shraddha Vivekanand  NIMS Dental College and Hospital  Department No. 7, 2nd Floor, PG Section, Department of Pediatric and Preventive Dentistry, NIMS Dental College and Hospital, NIMS University, Rajasthan, Jaipur 303121
Jaipur
RAJASTHAN 		 7745073955

shereshraddha96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, NIMS University, Rajasthan, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chitosan irrigating solution  Antibacterial efficacy of Chitosan will be evaluated by comparing the pre and post irrigation sample taken from root canal of non-vital primary teeth. 
Comparator Agent  Chlorhexidine  Antibacterial efficacy of Chlorhexidine will be evaluated by comparing the pre and post irrigation sample taken from root canal of non-vital primary teeth. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Primary teeth with chronic pulpitis, chronic periapical abscess, acute exacerbation of chronic pulpitis, and chronic periapical abscess
Primary molars with minimal mobility and restorable crown
Minimal root resorption
No sinus tract
Parents/caregivers acceptance and cooperation. 
 
ExclusionCriteria 
Details  Teeth having furcal lesions more than 5 mm diameter or periapical lesions exceeding 10 mm diameter.
Children with systemic diseases and patients undergone antibiotic therapy in the past 3 months.
Children whose parents have refused to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of bacterial load before and after irrigation to assess the antibacterial efficacy of 2% Chlorhexidine and 6% Chitosan in pediatric patients  Baseline (Before Intervention): Pre-treatment microbial sampling will be collected immediately after access opening
Post-irrigation (After Intervention): Sample will be collected 30 minutes irrigation to assess the reduction in bacterial load. 
 
Secondary Outcome  
Outcome  TimePoints 
Antibacterial efficacy of two different irrigants used  Pre-irrigation and post-irrigation 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/09/2024 
Date of Study Completion (India) 21/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
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   The randomised clinical trial aims to compare the antibacterial efficacy of 2% Chlorhexidine and 6% Chitosan as irrigating solutions in non-vital primary teeth. Children between 4 to 9 age group without any systemic disease will be enrolled. Access opening of the non-vital tooth will be done under all aseptic conditions. Pre-irrigation sample will be collected with sterile paper points and after using irrigant post-irrigation sample will be collected and transferred to sterile transport media immediately. Both the samples will be incubated on blood agar. Colonies formed will be counted to assess the bacterial load. 
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