Treatment Outcome of Partial Pulpotomy by Using Two Different Bioactive Materials in Mature Permanent Teeth With Signs and Symptoms of Irreversible Pulpitis. A CONSORT Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 主要终点
- Number of successful cases with vital and healthy pulp during the follow-up period
研究概览
简要总结
The main purpose of the present study is to assess the outcome of partial pulpotomy by using two different bioactive materials, namely MTA [MTA Angelus (Angelus, Londrina, Brazil) and Total Fill BC putty (FKG, La Chaux-de-Fonds, Switzerland) bioceramic material in mature teeth with deep caries and clinical symptoms indicative of irreversible pulpitis. A secondary aim is to evaluate whether age, tooth type and coronal restoration play a significant role on the outcome of partial pulpotomy in the evaluated cases.
详细描述
Study design This is a randomized controlled clinical superiority trial, parallel designed which will be conducted in compliance with the CONSORT and PRIRATE 2020 guidelines for reporting randomized trials in Endodontology recently published by the ESE (Nagendrababu et al. 2020a, b). During the study, two different bioactive materials will be tested upon their placement on exposed pulps of mature teeth with preoperative signs and symptoms indicating the presence of irreversible pulpitis. Patients referred to the Postgraduate Clinic of Endodontology of Dental School of National and Kapodistrian University of Athens, will participate in the study.
Sample size calculation For sample size calculation, the Stata version 15.1 software (Stata Corp, College Station, Texas, USA) has already been used. Based on the results of a previous study by Taha & Khazali (2017) and expecting a 85% success rate for tested materials with 80% power of analysis and determining the level of statistical significance at 5%, the number of patients in each group was determined to be 65 (n = 65).
Randomization/Allocation concealment/Bliniding The randomization of the patients in the study has been taken place by using the web-based software of www.randomizer.org. This software gives automatically numbers to patients allocating them randomly in the study groups. Patients will be blinded to the type of the material used in their tooth. The operator could not be blinded during the study. An experienced endodontist (more than 15 years of clinical experience) will assess the follow-up radiographs and will be blinded to the capping material used in each case.
Data collection Demographic data such as age and sex and data regarding the tooth type and location will be collected.
Preoperative clinical and radiographic examination At the first appointment, the medical and dental history including the chief complaint will be recorded and then clinical and radiographic examination will take place. Accurate history of pain will take place to assess the severity of pain including the spontaneity or the lingering of pain after temperature stimulation and the sleep disturbance. The patients that meet the inclusion criteria will be informed in details about the aims of the study and those who will give permission will sign an informed consent and will be added to the study with a recognition number.
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 10 years old.
- •Written consent after their update regarding the study and its aims.
- •Noncontributory medical history.
- •Extremely deep caries extending to the pulp chamber.
- •Positive response to cold sensibility testing.
- •Presence of spontaneous pain or provoked lingering pain to cold stimuli.
- •No clinical signs of pulp necrosis such as swelling or presence of a sinus tract.
- •Restorable and periodontally sound teeth.
排除标准
- •Immature teeth.
- •Cariously involved teeth with no response to pulp sensibility tests.
- •No signs and symptoms of irreversible pulpitis.
- •Bleeding not controlled in 10 minutes after partial pulpotomy.
- •Teeth with no evidence of bleeding after communication with the pulp chamber (necrosis of the coronal pulp tissue)
- •Teeth with the pulp chamber exposed to the oral environment.
- •Detection of periodontal pocket with depth greater than 4mm.
- •Teeth suspected for crack or incomplete crown fracture possibly responsible for pulp pathology.
- •Medically compromised patients.
结局指标
主要结局
Number of successful cases with vital and healthy pulp during the follow-up period
时间窗: 1-4 years
The primary outcome will be defined clinically in the absence of pathologic signs and symptoms such as spontaneous or lingering pain, tenderness to percussion and swelling as well as the response to cold sensibility test. Radiographically, the assessment of periapical tissues will take place. If the periapical tissues were normal preoperatively, they should continue to be normal. If a periapical radiolucency was present preoperatively, then a complete healing of periapical tissues should be accomplished. Under the above conditions, the case will be considered successful. If a case presents severe spontaneous or lingering pain, tenderness or pain to percussion, swelling or sinus tract with persistence of periapical lesion or emergence of a new one, will be considered as failure.
次要结局
- Assessment of pain after pulpotomy procedure using the Heft-Parker visual analog scale(One week after the intervention)
研究者
Giorgos Tzanetakis
Assistant Professor
National and Kapodistrian University of Athens