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CTRI Number  CTRI/2024/08/072626 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 16/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Bioactive restoration in proximal primary molars.  
Scientific Title of Study   In vivo – evaluation of a novel bioactive restorative resin in proximal restorations of primary molars- A comparative 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 ARUN E 
Designation  Professor and Head Of the Department 
Affiliation  Madha Dental College 
Address  Madha Dental College Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069

Kancheepuram
TAMIL NADU
600069
India 
Phone  9585111025  
Fax    
Email  bilal4u93@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ARUN E 
Designation  PROFESSOR & HEAD OF THE DEPARTMENT 
Affiliation  MADHA DENTAL COLLEGE 
Address  MADHA DENTAL COLLEGE Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069

Kancheepuram
TAMIL NADU
600069
India 
Phone  9585111025  
Fax    
Email  arunetam@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR ARUN E 
Designation  PROFESSOR & HEAD OF THE DEPARTMENT 
Affiliation  MADHA DENTAL COLLEGE 
Address  MADHA DENTAL COLLEGE Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069

Kancheepuram
TAMIL NADU
600069
India 
Phone  9941377203  
Fax    
Email  bilal4u93@gmail.com  
 
Source of Monetary or Material Support  
icon dental care 
 
Primary Sponsor  
Name  KHADER SHERIFF  
Address  ICON DENTAL CARE NO 38 NH1 VALLAL MGR SALAI MARAI MALAI NAGAR 603209 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
SHIFA  ICON DENTAL CARE NO 38 NH1 VALLAL MGR SALAI MARAI MALAI NAGAR 603209 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrBilal  madha dental college  Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Kancheepuram
TAMIL NADU 
9585111025

bilal4u93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MADHA DENTAL COLLEGE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  patients with class II dental caries affecting the primary molars 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DrBilal  Postgraduate 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Apparently healthy and cooperative.
Children in the age range of 4 to 9 years.
Children with clinically detectable proximal carious lesions. (ICDAS II Scores 3,4,5) 
 
ExclusionCriteria 
Details  Primary teeth with deep carious lesions / pain
Children who are on iron supplements or any other medication that can cause discolouration of the teeth & restoration.
Children with special health care needs / uncooperative children / lack of compliance.
Children with the evidence of parafunctional habits.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To check the different restoration used in proximal areas of primary tooth  3 months interval 
 
Secondary Outcome  
Outcome  TimePoints 
To check the different restoration used in proximal areas of primary tooth  3 month period 
 
Target Sample Size   Total Sample Size="258"
Sample Size from India="258" 
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)   28/08/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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      Restorative therapy is a part of comprehensive dental care for management of

dental caries that depends on several factors such as caries-risk assessment,

longevity and durability of the dental materials, type of restoration necessitated,

patients’ cooperation towards treatment, and development status of the

primary/permanent dentition, anticipated compliances, and other environmental

influences.

Conventional restorative procedures of extensively damaged or destroyed

carious teeth is a challenging task as removal of the tooth was the principal

mode of treatment for the primary tooth particularly at the anterior region in the

past followed by replacement with an artificial prosthetic substitute until the

eruption of permanent tooth. This may result in psychological impact on the

child by affecting the confidence and normal personality development apart

from esthetical compromise, abnormal habits and speech difficulties.

Restorative materials used in pediatric dentistry should possess specific characteristics such as biocompatibility, durability, aesthetics, and ease of use, to ensure successful outcomes. This study aims to explore a new restorative material that meets these requirements and can potentially enhance the quality of pediatric dental care.

 
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