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临床试验/NCT02918903
NCT02918903已完成不适用

Evaluation of Pulpal Symptoms Following Minimal Caries Removal Technique in Comparison to Complete Caries Removal in Molars With Deep Caries

Cairo University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Post operative pain assessed by direct questioning as binary outcome

研究概览

简要总结

The objective of this study is to assess and compare the possible post-operative pulpal symptoms (Spontaneous pain, pain on percussion, swelling, sinus or fistula), incidence of pulp exposure, child acceptance, chair time and radiographic success between two techniques for managing dental caries: minimal caries removal and complete caries removal in primary molars.

详细描述

Minimal Caries Removal (MCR) technique was described in 2015 by Chompu-inwai et al., as a treatment option for primary molars with deep carious lesions or reversible pulpitis where only soft demineralized dentin around the lateral walls of the carious lesion is removed. The aim of this study is to assess the success of such a technique in managing primary molars with asymptomatic deep caries in terms of; post-operative pulpal symptoms(spontaneous pain, pain on percussion, fistula or sinus), incidence of pulp exposure, child acceptance, chair time and radiographic success.

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
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Primary molar with deep dentin caries involving occlusal &/or occluso-proximal surfaces.
  • Absence of clinical signs and symptoms of irreversible pulpitis such as spontaneous pain. Only presence of pain provoked with stimulation, such as complaints of food impaction when eating is allowed.
  • Absence of clinical swelling or pus exudates/fistula of soft or periodontal tissues.
  • Absence of abnormal tooth mobility.
  • Absence of pain on percussion.
  • Restorable tooth.
  • Radiographic inclusion criteria:
  • Extension of dental caries one-third or more of the entire dentin thickness.
  • No super- imposition of dental caries on the dental pulp.
  • No widened periodontal ligament (PDL) space.
  • No radiolucency in the peri-apical or furcation areas.
  • No pathologic internal or external root resorption.
  • No pulp canal calcification or obliteration.

排除标准

  • Patients experience any signs or symptoms of pulpal or peri-apical pathology.
  • Patients with systemic diseases requiring special dental consideration.
  • Unmotivated, uncooperative patients.
  • Patients unable to attend follow-up visits.

结局指标

主要结局

Post operative pain assessed by direct questioning as binary outcome

时间窗: 9 months

Assessed by direct questioning pain history

次要结局

  • incidence of pulp exposure(Within 30 minutes)
  • radio-graphic success(9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nouran Mamdouh Ahmed

Assistant lecturer

Cairo University

研究点 (2)

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