Comparison of clinical efficacy and pain perception with new chemomechanical caries removal agent and conventional caries removal method in primary molars : A randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- clinical efficacy
研究概览
简要总结
This study will compare the clinical efficacy and pain perception of children towards the use of two different caries removal methods. First method is the traditional means of caries removal using high speed handpieces and second method is the chemomechanical means of caries removal using BRIX3000, a papain based agent. The children will be selected for the study based on the Inclusion criteria and will be allocated into either the BRIX3000 group or Conventional rotary method. The parameters to be assessed are clinical efficacy and pain perception using Wong-Baker faces pain rating scale. These parameters will be assessed after the caries removal. The outcomes of this study will determine which caries removal method will derive better clinical results along with child favourable technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor 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 having occlusal carious lesion on maxillary and/or mandibular either first or second primary molar.
- •the teeth will be selected based on the Mount and Hume classification of 1.2
- •the children whose parents will give the written informed consent for study.
排除标准
- •Children suffering from any illness requiring special medical care.
- •Children having teeth with pulp exposure, spontaneous pain, mobility, swelling or fistula next to the tooth, furcation or cervical lesion, and teeth with restorations, sealants or enamel defects.
结局指标
主要结局
clinical efficacy
时间窗: this parameter will be assessed after the caries removal procedure
次要结局
- pain perception using Wong-Baker faces pain rating scale(this parameter will be assessed after the caries removal procedure)