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
|
|
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
|
|
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. |