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CTRI Number  CTRI/2025/09/094798 [Registered on: 15/09/2025] Trial Registered Prospectively
Last Modified On: 20/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing Gentle Less Painful Methods to Remove Tooth Decay in Children by using Atraumatic restorative treatment, polymer bur, and chemomechanical caries removal agent to overcome the child fear during dental treatment. 
Scientific Title of Study   Comparative Evaluation and Efficacy of Minimal Invasive Approach of caries excavation using Atraumatic Restorative Treatment polymer bur and Chemo Mechanical Caries Removal agent An in vivo 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 DEVIKA AGRAWAL 
Designation  PG Resident 
Affiliation  Hitkarini Dental College and Hospital 
Address  ROOM NO. 8 GROUND FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
HITKARINI DENTAL COLLEGE AND HOSPITAL
Jabalpur
MADHYA PRADESH
482001
India 
Phone  8319248080  
Fax    
Email  agrawaldevika1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR DEVIKA AGRAWAL 
Designation  PG Resident 
Affiliation  Hitkarini Dental College and Hospital 
Address  ROOM NO. 8 GROUND FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
HITKARINI DENTAL COLLEGE AND HOSPITAL
Jabalpur
MADHYA PRADESH
482001
India 
Phone  8319248080  
Fax    
Email  agrawaldevika1996@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SAURABH TIWARI 
Designation  READER and GUIDE 
Affiliation  Hitkarini Dental College and Hospital 
Address  ROOM NO. 8 GROUND FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
HITKARINI DENTAL COLLEGE AND HOSPITAL
Jabalpur
MADHYA PRADESH
482001
India 
Phone  7742591007  
Fax    
Email  drsaurabhtiwari297@gmail.com  
 
Source of Monetary or Material Support  
HITKARINI DENTAL COLLEGE AND HOSPITAL HITKARINI HILLS DUMNA JABALPUR MP 482001 
 
Primary Sponsor  
Name  DR DEVIKA AGRAWAL 
Address  HITKARINI DENTAL COLLEGE AND HOSPITAL HITKARINI HILLS DUMNA JABALPUR MP 482001 
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 DEVIKA AGRAWAL  Hitkarini Dental College and Hospital  ROOM NO. 8 GROUND FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
Jabalpur
MADHYA PRADESH 		 08319248080

agrawaldevika1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ATRAUMATIC RESTORATIVE TREATMENT  Caries was removed using a sterile sharp spoon excavator until the point where hard dentin was obtained; later it was detected with the help of a probe at the base of the cavity 
Intervention  CHEMOMECHANICAL CARIES REMOVAL AGENT  Apply 1 or 2 drops of DENGEN CARIE FIX CARE to the carious dentin using applicators. Wait for 30-60 seconds. The chemical process softens the caries. Scrape off the softened carious dentin using a hand instrument 
Intervention  POLYMER BUR  Caries will be excavated with Smart Burs in slow speed handpiece with circular movements starting from the periphery to the center of the lesion 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children with definitely positive or positive according to frankl behaviour rating scale.
2.Healthy children from 6 to 12 years of age who are willing to participate in the study.
3.Patient with asymptomatic carious lesion with distinct dentin involvement, verified by radiographic examination.
4.Carious lesion without any pulpal involvement.
5.Teeth with no radiographic signs of internal and external resorption.
6.No furcation radiolucency.
 
 
ExclusionCriteria 
Details  1.Non-consent of parent to participate in the study.
2.Uncooperative patient.
3.Teeth with history of spontaneous pain.
4.Deep carious lesion with pulpal involvement.
5.Medically compromised children.
6.Tooth with restoration or fracture.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
ANXIOUSLESS AND FEARLESS TREATMENT FOR CHILDREN  BASELINE, 3 MONTHS, 6 MONTHS  
 
Secondary Outcome  
Outcome  TimePoints 
better marginal adaptability and
less chances of secondary caries  		 BASELINE, 3 MONTHS, 6 MONTHS  
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   24/09/2025 
Date of Study Completion (India) 17/04/2026 
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)
Modification(s)  		 Not Applicable 
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   To evaluate and compare the pain dimensions, patient acceptability and clinical and radiographic success of caries removal with Atraumatic Restorative Technique (ART), Polymer bur and CMCR agent among six to twelve years old children. 
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