Success of Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions- A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Clinical success
研究概览
简要总结
The aim of this clinical study is to compare and evaluate the Success of Selective Caries vs Stepwise Caries Removal Techniques in treatment of dental caries.
详细描述
The patient will be selected as per the pre-defined eligibility criteria. Written informed consent will be taken from each consenting participant. Initial caries excavation will be done under rubber dam isolation. The patient will then be randomly allocated to two groups: selective removal to soft dentin or stepwise caries removal. Composite restoration with glass ionomer liner will be then placed in both groups. Additional complete caries excavation will be done in the stepwise caries removal group after six months.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient in age range of 18yr-60yr
- •Permanent mandibular posterior teeth with deep caries
- •Caries extending to >3/4 of dentin with a layer of sound dentin between pulp and carious tissue as seen on radiograph
- •Positive response to cold test and electric pulp test
排除标准
- •Any general disease affecting the caries e.g. patient under head and neck radiotherapy
- •Patients with immuno-compromised status
- •Tooth with fracture line, cracks.
研究组 & 干预措施
Selective caries removal to soft dentin (one step)
In selective caries removal to soft dentine, after caries excavation application of liner will be done on pulpal floor. Teeth will then be filled with composite resin material.
干预措施: Selective caries removal (Procedure)
Stepwise caries removal (two step)
The stepwise caries removal is a two step procedure. The first step is similar to selective caries removal to soft dentin group. In the second step, after 6 months lesion will be re-entered to remove remaining carious tissue till firm dentin is encountered. Once all the caries is removed from floor of cavity a liner followed by final restoration with composite will be performed.
干预措施: Stepwise caries removal (Procedure)
结局指标
主要结局
Clinical success
时间窗: Baseline to 12 months
Clinical success will be judged by following criteria * Positive response on vitality test. * Absence of pain on percussion and any other signs and/or symptoms of irreversible pulpitis and pulp necrosis Criteria for failure will be * Negative response on pulp vitality test. * Tenderness to percussion and teeth exhibiting any clinical signs and/or symptoms of irreversible pulpitis and pulp necrosis.
次要结局
- Radiographic Success(Baseline to 12 months)