A Clinical and Microbiological Assessment of the Efficacy of Chemo-mechanical Caries Removal Versus Conventional Caries Removal Methods in Children: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical evaluation
研究概览
简要总结
This study will be conducted to Assess the clinical and microbiological efficacy of chemomechanical caries removal (CarieMove® Gel) versus conventional excavation method in children.
The assessed parameters will be:
- Efficacy of caries removal.
- Pain reaction and mean time required for the treatment.
- Total bacterial count before and after treatment.
详细描述
Subjects:
A total of 30 children 7-9 years old with no history of systematic disease will be recruited from the out-patient pediatric dental clinic, Faculty of Dentistry, Mansoura University.
Each child with the following criteria will be eligible for the present study (22).
Inclusion criteria:
- Cooperative child
- Each child has two bilateral first permanent molars with simple Class 1 occlusal caries involving dentin.
- The carious first permanent molars are free from clinical and radiographic evidence of pulp involvement.
- The selected molars should have normal structure and morphology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperative child
- •Each child has two bilateral first permanent molars with simple Class 1 occlusal caries involving dentin.
- •The carious first permanent molars are free from clinical and radiographic evidence of pulp involvement.
- •The selected molars should have normal structure and morphology.
排除标准
- •1- Un-cooperative child 2- Molars with clinical and radiographic signs of pulp involvement. 3- Children with special health care needs. 4- Molars which have already been restored or have developmental anomaly.
研究组 & 干预措施
Chemo-mechanical caries removal
A Chemo-mechanical caries removal agent for one side of the bilateral carious teeth (selected randomly). Application of the material will be done according to the manufacturer's instructions
干预措施: Chemo-mechanical caries removal (Other)
Conventional drilling method
- In this group, caries removal was performed using a low-speed handpiece with a carbon steel round bur.
- The cavities were then examined using the same criteria that had been used with Group I to assess for any remaining caries.
- After caries removal, a dentin sample was taken from the cavity floor in both groups using a sterile sharp spoon excavator.
- The dentin sample was transported to a sterile screw-cap vial for bacterial count examination.
干预措施: Chemo-mechanical caries removal (Other)
结局指标
主要结局
Clinical evaluation
时间窗: 11.2 ± 3.3 min
A-Efficacy: B- Child satisfaction and pain experience: C-Time assessment
次要结局
未报告次要终点