Comparing the pain response, effectiveness and duration of caries removal using a papain based gel and an ultrasonic excavator tip in deciduous molars: A split mouth randomized controlled trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- The primary outcome of the study is to assess the effectiveness of caries removal using Ericson criteria
研究概览
简要总结
This study is to evaluate the efficacy of caries removal, amount of time taken and the pain experienced by the children aged 4 to 7 years using brix 3000 and ultrasonic excavator in primary molars. It is a randomized controlled trial with split mouth design. The sample size is estimated to be 62 with 1:1 allocation ratio, simple random sampling. The methodology includes caries removal checked using an explorer. The time taken for complete caries removal was recorded and compared using a stopwatch. The pain threshold of caries removal measured by wong bakers Scale and flacc, assessing the retention, marginal discoloration, secondary caries, marginal adaptation of restoration at 3, 6 months using USPHS criteria. The obtained data will be subjected to statistical analysis.
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 and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Presence of two contralateral open carious lesion with dentin involvement 2.Cavities are assessible to facilitate the penetration of a small size excavator.
- •3.Teeth and surrounding tissues should be clinically free of any pathologic conditions other than dental caries 4.Presence of asymptomatic carious molars without clinical evidence of pulp involvement 5.Class I carious lesion.
排除标准
- •1.non vital teeth 2.arrested caries 3.Children with systemic diseases 4.Grossly decayed
- •Caries in primary teeth exhibiting pre shedding mobility.
- •periodontal problem.
结局指标
主要结局
The primary outcome of the study is to assess the effectiveness of caries removal using Ericson criteria
时间窗: within 30 minutes
次要结局
- 1.The secondary outcomes of the study is to assess the pain response of children using Wong Bakers scale and FLACC.(2.To assess the total working time required for caries removal using Brix 3000 and ultrasonic excavator recorded in minutes using a stopwatch)