Clinical and Radiographic Outcome of Endodontic Retreatment in One or Two Visits: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Clinical signs or symptoms of periapical disease 10
研究概览
简要总结
This study is a prospective randomized controlled study of patients who come to the University and non-surgical root canal retreatment is considered as the election of choice in presence of periapical disease. The aim is to evaluate the success rate of non-surgical retreatment performed in one compared to two visit treatment up to 10 years of follow-up. The null hypothesis is that there will be no statistically significant differences in rates of success, when performing root canal non-surgical retreatment in one or two visits.
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
- 否
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.
- •Retreatment cases due to an endodontic failure.
- •Diagnosis of apical periodontitis.
- •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 secondary root canal treatment is not the treatment of choice.
结局指标
主要结局
Clinical signs or symptoms of periapical disease 10
时间窗: 10 years
Absence/presence of clinical signs or symptoms of periapical disease
Clinical signs or symptoms of periapical disease 4
时间窗: 4 years
Absence/presence of clinical signs or symptoms of periapical disease
Clinical signs or symptoms of periapical disease 1
时间窗: 1 year
Absence/presence of clinical signs or symptoms of periapical disease
Clinical post-operative pain
时间窗: 48 hours post treatment
VAS score (0-10) of patient' level of pain, from no pain to extreme pain
Clinical signs or symptoms of periapical disease 2
时间窗: 2 years
Absence/presence of clinical signs or symptoms of periapical disease
Clinical signs or symptoms of periapical disease 6
时间窗: 6 years
Absence/presence of clinical signs or symptoms of periapical disease
Radiographic periapical absence/presence of radiographic apical periodontitis
时间窗: 1 year
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Radiographic periapical absence/presence/changes in radiographic apical periodontitis
时间窗: 10 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 1(1 year)
- Correlation of prognostic factors and clinical signs or symptoms of periapical disease 6(6 years)
- Correlation of prognostic factors and clinical signs or symptoms of periapical disease 2(2 years)
- Correlation of prognostic factors and clinical signs or symptoms of periapical disease 4(4 years)
- Correlation of prognostic factors and clinical signs or symptoms of periapical disease 10(10 years)
研究者
Juan Gonzalo Olivieri
Principal investigator
Universitat Internacional de Catalunya