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
- 1
- 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.
研究组 & 干预措施
1-vist endodontic retreatment
Non-surgical root canal retreatment performed in one visit
干预措施: Non-surgical root canal retreatment (Procedure)
2-vist endodontic retreatment
Non-surgical root canal retreatment performed in two visits
干预措施: Non-surgical root canal retreatment (Procedure)
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
Clinical post-operative pain
时间窗: Immediately post treatment
VAS score (0-10) of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
时间窗: 4 hours post-treatment
VAS score (0-10) of patient' level of pain, from no pain to extreme pain
Clinical post-operative pain
时间窗: 24 hours post treatment
VAS score (0-10) of patient' level of pain, from no pain to extreme pain
Radiographic periapical absence/presence/changes in radiographic apical periodontitis
时间窗: 2 years
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: 4 years
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: 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 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