跳至主要内容
临床试验/CTRI/2025/08/092930
CTRI/2025/08/092930尚未招募Phase 3 4

Comparative evaluation of assessing caries removal efficiency and pain perception in 6-8 years old children using carbide bur, diamond burs, smart bur and ceramic bur:A randomized clinical study

Kareena Singh1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月25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
80
试验地点
1
主要终点
Caries Removal Efficiency

研究概览

简要总结

Dental caries is one of the most common chronic conditions affecting children globally, particularly between 6 to 8 years of age. Effective caries removal with minimal discomfort is essential in pediatric dentistry to ensure child cooperation and prevent dental fear. Conventional burs such as carbide and diamond are efficient but often cause pain and anxiety. Newer minimally invasive instruments like smart burs and ceramic burs offer promising alternatives by preserving healthy dentin and reducing pain.

This randomized clinical trial aims to compare four types of burs—carbide, diamond, smart, and ceramic—in terms of caries removal efficiency and pain perception in 6–8-year-old children. Eighty cooperative children with occlusal dentinal caries in mandibular primary molars will be randomly assigned to one of the four groups. Pain will be assessed using the Wong-Baker FACES scale and FLACC scale, while clinical effectiveness will be evaluated using caries detection dye and a validated scoring system. The time taken for caries removal and the behavioral response (Frankl scale) will also be recorded.

The study is designed to provide evidence-based recommendations for pediatric dentists in selecting child-friendly caries excavation methods that balance clinical efficiency with patient comfort.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
6.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Cooperative children aged between 6 to 8 years Frankl rating 3 or 4 Children with good physical and mental health without any history of systemic disease Presence of at least one occlusal carious lesion involving dentinal caries without pulpal involvement in mandibular primary molars indicated for restorative treatment Mandibular primary molars fulfilling international caries detection and assessment system code 4 Mandibular primary molars using radiographs fulfilling international caries classification and management system RB4 radiolucency reaching the middle one-third of dentin.

排除标准

  • Non-cooperative children Frankl rating 1 or 2 Deep carious lesions with pulpal involvement Teeth that have previous restorations or partially excavated caries in the same lesion Children with cognitive impairments mental disabilities or special health care needs that affect their ability to undergo standard dental procedures.

结局指标

主要结局

Caries Removal Efficiency

时间窗: Caries Removal Efficiency | Pain Perception caries will be checked immediately after the procedure and pain will be checked before and after the procedure

Pain Perception

时间窗: Caries Removal Efficiency | Pain Perception caries will be checked immediately after the procedure and pain will be checked before and after the procedure

次要结局

  • Time Taken for Caries Removal(Childs Behavior)

研究者

发起方
Kareena Singh
申办方类型
Other [other ( Self)]
责任方
Principal Investigator
主要研究者

Kareena Singh

Pacific Dental College And Hospital Debari Udaipur

研究点 (1)

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