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临床试验/NCT05190406
NCT05190406Unknown不适用

Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment in Teeth With Clinical Signs Indicative of Irreversible Pulpitis

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Radiographic success rate

研究概览

简要总结

The purpose of this study is to compare the Success and quality of life following complete pulpotomy and root canal treatment in teeth with clinical signs indicative of irreversible pulpitis.

详细描述

After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, risks and benefits associated with the procedure will be explained and written informed consent will be taken from the patients. Study subjects will be randomly allocated to either Complete pulpotomy or Root canal treatment Group.

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)

盲法说明

outcome assessor will be blinded

入排标准

年龄范围
14 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Mature permanent restorable mandibular molar teeth.
  • Tooth should give positive response to pulp sensibility testing.
  • Clinical diagnosis of irreversible pulpitis with PAI score≤
  • Tooth with probing pocket depth and mobility are within normal limits.
  • Non-contributory medical history.

排除标准

  • Teeth with immature roots.
  • No pulp exposure after caries excavation.
  • Bleeding could not be controlled in 6 minutes.
  • Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.
  • Absence of antagonist tooth.
  • Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis
  • Had taken analgesic in past 3 days.
  • Tooth with periapical lesion visible on radiograph

结局指标

主要结局

Radiographic success rate

时间窗: 6 months and one year

Radiographic success criteria No pathosis evident on the radiograph Periapical Index score 1 or 2

Clinical success rate

时间窗: 6 months and one year

Clinical success criteria No history of spontaneous pain No tenderness to palpation or percussion Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.

次要结局

  • Pain assessment(baseline to one week)
  • Oral Health related quality of Life(baseline to one week, 6 months and one year)

研究者

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

Sanjay Tewari

Principal

Postgraduate Institute of Dental Sciences Rohtak

研究点 (2)

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