跳至主要内容
临床试验/NCT02920606
NCT02920606Unknown不适用

Pulpotomy as a Permanent Treatment of Irreversible Pulpitis on Mature Molar Teeth - a Pilot Study

Cliniques universitaires Saint-Luc- Université Catholique de Louvain0 个研究点目标入组 100 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Evaluation of the success rate (%) at 1 year

研究概览

简要总结

The procedure currently recommended for the treatment of irreversible pulpitis is the endodontic treatment, i.e. the complete elimination of the pulp, disinfection and obturation of the whole root canal system. The emergency procedure consists of a pulpotomy, followed at an ulterior appointment by the root canal treatment. The purpose of the present pilot study is to evaluate the feasibility of performing the pulpotomy as a permanent treatment in mature molars. If hemostasis can be achieved after removing the coronal part of the pulp, a tricalcium silicate cement will be directly applied on the remaining pulp at the root canal entrances. A short-term follow-up will be performed at one week by evaluating the pain relief of the patient. Long-term success will then be evaluated every year by verifying the absence of periapical radiolucency on the x-ray as well as the absence of clinical symptoms and signs. A standard root canal procedure will serve as control. During the pulpotomy treatment, blood sample with microcapillary will be performed. We will analyze a ratio of pro-inflammatory and anti-inflammatory cytokines.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Good general health
  • Not pregnant women
  • At least one permanent molar in irreversible pulpitis
  • Adult patient
  • Mentally competent

排除标准

  • Periapical radiolucency
  • Periodontical probing
  • Root fracture
  • Sinus tract
  • Swelling or mobility
  • External or/and internal resorption
  • Open apicies
  • A non restorable tooth

结局指标

主要结局

Evaluation of the success rate (%) at 1 year

时间窗: Follow up at 1 year for all patients included in the study

to evaluate the treatment success defined as the absence of clinical symptoms (pain, sinus tract..) and the absence of radiological symptoms (periapical radiolucency), in order to point the non-inferiority of the pulpotomy compared with the conventional treatment

次要结局

  • Evaluation of the correlation between pro/anti-inflammatory cytokines and the success of pulpotomy(Follow up at 1 year for all patients included in the study)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

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