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Clinical Trials/CTRI/2025/09/094798
CTRI/2025/09/094798
Recruiting
Phase 2/3

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

DR DEVIKA AGRAWAL1 site in 1 country66 target enrollmentStarted: September 24, 2025Last updated:
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Overview

Phase
Phase 2/3
Status
Recruiting
Sponsor
DR DEVIKA AGRAWAL
Enrollment
66
Locations
1
Primary Endpoint
ANXIOUSLESS AND FEARLESS TREATMENT FOR CHILDREN
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
6.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

ANXIOUSLESS AND FEARLESS TREATMENT FOR CHILDREN

Time Frame: BASELINE, 3 MONTHS, 6 MONTHS

Secondary Outcomes

  • better marginal adaptability and(less chances of secondary caries)

Investigators

Sponsor
DR DEVIKA AGRAWAL
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

DR DEVIKA AGRAWAL

Hitkarini Dental College and Hospital

Study Sites (1)

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