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CTRI Number  CTRI/2025/03/082909 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparison of Two Advanced tooth fillings: A Clinical Study 
Scientific Title of Study   Comparative evaluation of the clinical performance of an Alkasite restorative material and Bulk fill composite for class II restoration in primary molars - A Randomized Clinical Trial 
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 Aisha Yenepoya 
Designation  Postgraduate student 
Affiliation  Yenepoya Dental College 
Address  Department of pediatric and preventive dentistry, Yenepoya Dental College, Deralakatte, Mangalore 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7907108578  
Fax    
Email  37145@yenepoya.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sharan S Sargod 
Designation  Professor and HOD 
Affiliation  Yenepoya Dental College 
Address  Department of pediatric and preventive dentistry, Yenepoya Dental College, Deralakatte, Mangalore 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845120885  
Fax    
Email  sharansargod@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Aisha Yenepoya 
Designation  Postgraduate student 
Affiliation  Yenepoya Dental College 
Address  Department of pediatric and preventive dentistry, Yenepoya Dental College, Deralakatte, Mangalore 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7907108578  
Fax    
Email  37145@yenepoya.edu.in  
 
Source of Monetary or Material Support  
Yenepoya Dental College Deralakatte Mangalore 575018 India 
 
Primary Sponsor  
Name  Dr Aisha Yenepoya 
Address  Department of pediatric and preventive dentistry, Yenepoya Dental College, Deralakatte Mangalore 575018 India 
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 Aisha Yenepoya  Yenepoya Dental College  Department of pediatric and preventive dentistry, Yenepoya Dental College, Deralakatte, Mangalore 575018 India
Dakshina Kannada
KARNATAKA 		 7907108578

37145@yenepoya.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Alkasite tooth restoration or filling  In each patient, restoration of a class 2 carious tooth in primary molar using an alkasite restorative material on one side of the mouth and checking its clinical performance for a duration of 1 year, with follow ups (baseline,3,6,9,12 months) using fdi criteria, in case of any dislodgement of filling material, Re-restoration will be done. 
Comparator Agent  Bulk fill composite tooth restoration/filling  In each patient, restoration of a class 2 carious tooth in primary molar using a bulk fill composite restorative material on other side of the mouth and checking its clinical performance for a duration of 1 year, with follow ups (baseline,3,6,9,12 months) using fdi criteria and comparing it with intervention group, in case of any dislodgement of filling material, Re-restoration will be done. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Patients in the age group of 4-9 years presenting with proximal carious lesions on primary maxillary or mandibular molars on either side (bilateral) of the arch.
Presence of two class II carious lesions on maxillary or mandibular primary molars, with no signs of pulpitis or necrosis bilaterally.
The ICDAS score of the caries has to be lower than 5 (visible dentin in a distinct cavity) and the caries score of 2.1-2.2 according to the Graham J
Mount classification.
Cavities with buccolingual width that involved less than 2/3 of the intercuspal distance or required cusp coverage 
 
ExclusionCriteria 
Details  Behaviorally uncooperative children
Children with special health care needs with intellectual disabilities
Children with parafunctional habits like bruxism
Teeth with proximal cavities that involved more than two surfaces
Children with habitual chewing on unilateral side
Inadvertent pulp exposure during cavity preparation
Lack of gingival seat area 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical success rate of Alkasite and Bulk fill composite restorative material in pediatric dentistry interms of esthetic, functional and biological properties.  one year 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical success rate of Alkasite restoration compared it with Bulk fill composite restoration.  one year 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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 2 
Date of First Enrollment (India)   01/04/2025 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 study aims to evaluate the clinical performance of an Alkasite restorative material and compare it with Bulk fill composite in class II restorations in primary molars. The result obtained from this study may help clinician to choose appropriate restorative material for class II cavities in primary molars and may lead to improved clinical outcomes.
It is an Academic Randomized Clinical Trial, an Interventional study.A total of 26 patients aged 4-9 years with occluso-proximal carious lesions on primary maxillary or mandibular molars will be selected from the OPD of Department of Pediatric and Preventive Dentistry, Yenepoya Dental College. This study will be conducted after obtaining the institutional ethics committee clearance in the Department of Pediatric and Preventive Dentistry. Parents will be given a brief introduction explaining the procedure. Informed written consent will be obtained from parents of the selected participant. Restorative treatment of Class II Caries will be done using Cention Forte (Group A) on one side and Tetric N Ceram (Group B) on other side. Esthetic, functional and biological properties will be assessed using FDI Criteria at baseline and thereafter at 3, 6, 9, and 12 months, respectively.The above results will be subjected to statistical analysis.
 
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