Microbiological Assessment After Chemo-Mechanical Caries Removal Using Papain-based Enzyme Versus Conventional Rotary Tools in Occlusal Carious Lesions: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 2
- 主要终点
- bacterial count by Digital Colony Counter
研究概览
简要总结
This study will be conducted to assess the efficacy of caries excavation using the papain-based chemo-mechanical method (Brix 3000) in comparison to conventional rotary tools in the reduction of the bacterial population in occlusal carious cavities
详细描述
Twenty-three patients who will fulfill the inclusion criteria will be enrolled to the study. For every patient two contra-lateral class I carious molars will be selected, so the total number of included molars will be 46 molars. One contra-lateral molar will be randomly assigned to the chemo-mechanical (Brix 3000) caries removal technique and the other will be assigned to the conventional rotary one. From every molar two dentin specimens will be collected (baseline and after excavation) with a total of 92 samples
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Class I carious lesions
- •Lower molars
- •Bilateral lesions
- •18 -50 years
- •Males or Females (Both genders)
- •Good oral hygiene
- •Co-operative patients approving the trial
排除标准
- •Systemic disease or severe medical complications
- •Periodontal problem
- •Mobile teeth, arrest caries and non-vital teeth
- •Lack of compliance
- •Not received antibiotic therapy since 1 month before sampling
研究组 & 干预措施
conventional
conventional 330 bur
干预措施: conventional rotary (Device)
conventional
conventional 330 bur
干预措施: Papain-based Chemo-mechanical caries removal agent (Drug)
papain chemomechenical caries removal agent (brix 3000)
papain chemomechenical caries removal agent (Birx 3000) and the exclusive Encapsulating Buffer Emulsifier (EBE) technology claim it has effective and selective proteolytic action
干预措施: Papain-based Chemo-mechanical caries removal agent (Drug)
papain chemomechenical caries removal agent (brix 3000)
papain chemomechenical caries removal agent (Birx 3000) and the exclusive Encapsulating Buffer Emulsifier (EBE) technology claim it has effective and selective proteolytic action
干预措施: conventional rotary (Device)
结局指标
主要结局
bacterial count by Digital Colony Counter
时间窗: at the same visit (20 minutes)
The number of colonies will be expressed as colony-forming units (CFU/ml) compared before and after removal caries using brix 3000 or rotary method
次要结局
未报告次要终点
研究者
Laila Akmal Emad Eldien Elokaly
Teaching assistant
Cairo University