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CTRI Number  CTRI/2020/07/026487 [Registered on: 10/07/2020] Trial Registered Prospectively
Last Modified On: 03/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Evaluation of the attachment of caries associated bacteria to two different types of crowns in children  
Scientific Title of Study   Assessment of adhesion of Streptococcus Mutans and Streptococcus Sobrinus to the preformed Stainless-steel crowns and Zirconia crowns in children: A Quantitative PCR based split mouth randomised 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 T Namratha 
Designation  Senior Lecturer 
Affiliation  AMEs Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry
Bijanegere Road
Raichur
KARNATAKA
584103
India 
Phone  9704058513  
Fax    
Email  namratha.tharay@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr T Namratha 
Designation  Senior Lecturer 
Affiliation  AMEs Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry
Bijanegere Road
Raichur
KARNATAKA
584103
India 
Phone  9704058513  
Fax    
Email  namratha.tharay@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Venkata Naidu 
Designation  Senior Lecturer 
Affiliation  AMEs Dental College and Hospital 
Address  Department of Orthodontics and Dentofacial Orthopaedics
Bijanegere Road
Raichur
KARNATAKA
584103
India 
Phone  9700627451  
Fax    
Email  naidu1661@gmail.com  
 
Source of Monetary or Material Support  
AMEs Dental College and Hospital Raichur Karnataka 584103 
 
Primary Sponsor  
Name  Self 
Address  Department of Pediatric and Preventive Dentistry AMEs Dental College and Hospital Raichur 584103 
Type of Sponsor  Research institution and hospital 
 
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 T Namratha  AMEs Dental College and Hospital  Department of pedodontics and preventive dentistry Bijanegere Road
Raichur
KARNATAKA 
9704058513

namratha.tharay@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AMEs Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental Caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Preformed Stainless Steel Crowns  Crown preparation will be made according to the manufacturers instructions and crown will be cemented. Further, the plaque developed on the crown will be evaluated. 
Intervention  Preformed Zirconia Crowns  Preformed zirconia crowns available in the market will be taken. Crown preparation will be perfomed according to the manufacturer intructions. After that, crown will be cemented.Further, the plaque developed on the crown will be evaluated. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children and parents willing to participate in the study
Children aged 6 to 9 years with two carious primary molars which requires endodontic therapy contralaterally
The primary tooth should be having at least two third of the roots
Children with Frank’s behaviour rating 3 & 4
 
 
ExclusionCriteria 
Details  Children with systematic health problems, periodontal disease, a unilateral chewing habit, or allergies to local anesthetics and/or nickel were excluded 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the adhesion of Streptococcus Mutans and Sobrinus to preformed zirconia and stainless steel crowns  1 week
1 month
3 months
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the adhesion of different serotypes of Streptococcus Mutans to preformed zirconia and staineless steel crowns  1 week
1 month
3 months
6 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   20/11/2020 
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="1"
Months="0"
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  

Purpose and Aim

Plaque accumulation on the surface of dental restorations leads to the development of secondary caries or new caries or gingival and periodontal inflammation. Hence, there is a need to assess which restorations favours or disfavour accumulation of plaque. Therefore, the aim of the present study is to evaluate and compare the adhesion of S Mutans and S Sobrinus to the preformed stainless-steel crowns and zirconia crowns in children aged 5-9 years

Methodology

the present study will be a single centered, two arm, explanatory, equivalence randomized clinical trial with split mouth study design and balanced allocation ratio of 1:1. 35 Children (35 teeth for stainless steel crowns and 35 teeth for zirconia crowns) who requires endodontic treatment of two carious primary molars and who met all the inclusion criteria will be included. The participants will be allotted to either of the two groups based on block randomization. A centralized assignment will be used as an allocation concealment mechanism to prevent selection bias. After that, endodontic treatment will be performed under local anaesthesia and the tooth is restored either with preformed stainless-steel crowns or zirconia crowns. Plaque samples will be collected from the buccal cervical surface of the crowns at 1 month, 3 months and 6 months of follow up and sent for bacterial analysis through PCR.

 
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