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临床试验/CTRI/2025/04/084994
CTRI/2025/04/084994尚未招募Phase 3 4

Comparative Evaluation of Novel Chemo-mechanical, Atraumatic Restorative Technique and Conventional Caries Removal Techniques in Primary Teeth - A Randomized Clinical Trial.

Dr Rubini M1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年5月5日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
Evaluating the efficacy, efficiency and pain perception associated with the use of bromelain gel for caries removal.

研究概览

简要总结

This study aims to compare and evaluate the clinical efficacy, efficiency, and pain response of three caries removal techniques: Bromelain gel chemo-mechanical caries removal, Atraumatic Restorative Treatment (ART), and conventional caries removal. The primary objective is to assess the efficacy, efficiency, and pain response of Bromelain gel in primary mandibular molars. Secondary objectives include evaluating and comparing ART and conventional techniques, as well as examining the anxiety and fear experienced by pediatric patients during the procedures. The study is a triple-blinded, parallel-arm, randomized clinical trial involving three groups, each consisting of 25 primary mandibular molars, for a total of 75 teeth. The intervention group will undergo Bromelain gel chemo-mechanical caries removal, while the comparison groups will receive ART and conventional caries removal. Inclusion criteria involve children aged 4 to 10 years with occlusal caries in primary mandibular molars and dentinal caries. Exclusion criteria include teeth with extensive damage, pulp involvement, or a history of pain, as well as children with medical or developmental conditions that may impact treatment. Caries removal will be evaluated through visual inspection and tactile sensation, with procedure duration recorded. Pain perception will be assessed using the Wong-Baker FACES pain scale (subjective) and the FLACC scale (objective).

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children aged between 4 – 10 years Presence of occlusal caries in primary mandibular molars with International Caries Detection and Assessment System (ICDAS II).
  • Radiograph showing dentinal caries up to two-thirds of the dentinal thickness.
  • The consistency of carious lesions ranges from soft to medium hard.
  • Color ranges from light yellow to brown.

排除标准

  • Extensively damaged teeth.Teeth that exhibit a history of pain.
  • Caries involving pulp or extending below the gingiva.
  • Medically or developmentally compromised conditions.

结局指标

主要结局

Evaluating the efficacy, efficiency and pain perception associated with the use of bromelain gel for caries removal.

时间窗: At baseline and immediately after intervention

次要结局

  • To compare the efficacy, efficiency, & pain response of caries removal using bromelain gel, atraumatic restorative technique & conventional technique.(To evaluate & compare the levels of anxiety & fear experienced by pediatric patients during caries removal with Bromelain gel, Atraumatic Restorative Treatment (ART), & the conventional technique.)

研究者

发起方
Dr Rubini M
申办方类型
Research institution and hospital

研究点 (1)

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