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