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Clinical Trials/CTRI/2025/12/098862
CTRI/2025/12/098862Not yet recruitingNot Applicable

COMPARATIVE EVALUATION OF THE EFFICACY, TIME TAKEN AND PAIN PERCEPTION OF PAPACARIE, V-CARIE-SOLVE AND CONVENTIONAL HAND INSTRUMENTATION FOR CARIES REMOVAL IN PRIMARY MOLARS: A RANDOMIZED CONTROLLED TRIAL

Dr. Neha Battulwar1 site in 1 country66 target enrollmentStarted: January 18, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
66
Locations
1
Primary Endpoint
1.To evaluate the clinical efficacy,microbial efficacy, time taken and pain perception of Papacarie, V-Carie-Solve and Conventional Hand Instrumentation for caries removal in primary molars.

Study Overview

Brief Summary

This randomized controlled trial aims to compare the clinical efficacy, microbial efficacy, time taken, and pain perception associated with three different caries-removal techniques—Papacarie, V-Carie-Solve, and conventional hand instrumentation—in primary molars of children aged 4–9 years. Sixty-six carious primary molars meeting strict inclusion criteria (ICDAS 5 or 6 lesions, radiographic dentinal involvement without pulpal extension, Frankl 3 or 4 behaviour) will be randomly assigned into three equal groups of 22 teeth each.

In Group I, caries removal will be performed using the papain-based chemomechanical gel Papacarie, applied for 30–40 seconds followed by gentle excavation. Group II will undergo a similar protocol using V-Carie-Solve, a newer papain- and clove-oil–based gel. Group III, the control group, will receive caries removal solely through conventional hand instrumentation using a spoon excavator.

Before and after excavation, dentinal samples will be collected and transported in Brain Heart Infusion Broth for microbiological analysis, with colony-forming units quantified using blood agar plating under anaerobic incubation. Clinical efficacy will be assessed through visual and tactile criteria using the Ericson 0–5 scoring system. Time taken for complete excavation will be recorded using a stopwatch, while pain perception will be evaluated using both subjective (Wong-Baker FACES) and objective (FLACC) scales during and after the procedure. Final restorations will be placed using glass ionomer cement.

The study seeks to determine whether chemomechanical agents offer superior comfort, reduced microbial load, and acceptable clinical performance compared to conventional hand excavation, ultimately contributing to minimally invasive and child-friendly dentistry.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
4.00 Year(s) to 9.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Children aged 4–9 years.
  • Broad cavitated occlusal lesion with dentinal involvement and occlusal access (ICDAS Score 5 or 6 and should be 3 x 4 mm in dimension).
  • Radiograph showing dentinal caries not involving pulp.
  • The consistency of carious lesions ranges from soft to medium hard.
  • Color ranges from light yellow to brown.
  • Patients exhibiting Frankl’s Behaviour Rating Scale score of 3 and 4.

Exclusion Criteria

  • Cases requiring restorative treatment that is not of the Class I variety.
  • Teeth with history of spontaneous or nocturnal pain
  • Extensively damaged teeth.
  • Radiograph showing caries involving pulp.
  • Medically or developmentally compromising conditions.

Outcomes

Primary Outcomes

1.To evaluate the clinical efficacy,microbial efficacy, time taken and pain perception of Papacarie, V-Carie-Solve and Conventional Hand Instrumentation for caries removal in primary molars.

Time Frame: At Baseline and immediately postop

Secondary Outcomes

  • To compare the clinical & microbial efficacy, time taken & pain perception of Papacarie, V-Carie-Solve & Conventional Hand Instrumentation for caries removal in primary molars.(12 months)

Investigators

Sponsor
Dr. Neha Battulwar
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Neha Battulwar

Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital, Nagpur

Study Sites (1)

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