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临床试验/NCT04375215
NCT04375215Unknown不适用

Success of Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions- A Randomized Clinical Study

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
146
试验地点
2
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

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.

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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