The Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer: A Prospective Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Clinical post-operative pain
研究概览
简要总结
This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of treatment and retreatment of canals using BioRoot ™ RCS cement compared with AH Plus up to 6 years of follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment of root canals filled with BioRoot ™ RCS compared to gutta-percha and AH Plus sealer.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form.
- •Understands and is willing to comply with all study procedures and restrictions.
- •Not presence of clinically significant and relevant abnormalities of clinical history or oral examination.
- •Diagnosis of irreversible pulpitis or apical symptomatic / asymptomatic periodontitis.
- •Retreatment cases due to an endodontic failure.
- •Single or bi-radicular teeth.
排除标准
- •General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities.
- •Specific: root resorption, root fractures, impossibility of restoration and cases were primary or secondary root canal treatment is not the treatment of choice.
结局指标
主要结局
Clinical post-operative pain
时间窗: 48 hours post treatment
VAS score of patient' level of pain, from no pain to extreme pain
Clinical signs or symptoms of periapical disease
时间窗: 6 years
Absence/presence of clinical signs or symptoms of periapical disease
Radiographic periapical healing
时间窗: 6 years
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
次要结局
- Correlation of prognostic factors and clinical signs or symptoms of periapical disease(6 years)
- Correlation of prognostic factors and radiographic periapical healing(6 years)
研究者
Juan Gonzalo Olivieri
Principal investigator
Universitat Internacional de Catalunya