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临床试验/CTRI/2025/12/098862
CTRI/2025/12/098862
尚未招募
不适用

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 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2026年1月18日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Dr. Neha Battulwar
入组人数
66
试验地点
1
主要终点
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.

概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
4.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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.

时间窗: At Baseline and immediately postop

次要结局

  • 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)

研究者

发起方
Dr. Neha Battulwar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Neha Battulwar

Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital, Nagpur

研究点 (1)

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