The Effect of Apical Preperation Size on the Success of Regenerative Endodontic Treatment in Mature Teeth With Apical Periodontitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Primer success
研究概览
简要总结
The goal of this clinical trial is to learn whether the size of apical preparation affects the success of regenerative endodontic treatment in mature permanent teeth with apical periodontitis. Regenerative endodontic treatment is a procedure that aims to eliminate infection and support healing of the tissues around the root of the tooth.
The main questions the study aims to answer are:
- Does a larger apical preparation improve healing around the root tip?
- Does apical preparation size affect pain after treatment or recovery of tooth vitality?
Researchers compared two treatment approaches that use different apical preparation sizes to see if one leads to better clinical and radiographic healing.
Participants:
- Received regenerative endodontic treatment with one of two apical preparation sizes
- Attended follow-up visits for clinical examination and radiographic evaluation
- Were monitored for pain and healing outcomes during the follow-up period
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single-rooted mature teeth with periapical lesions
- •Teeth with a PAI score ≥ 3
- •Patients aged 18-45 years
- •Systemically healthy individuals
- •Patients who provided written informed consent
排除标准
- •Immature teeth
- •Previously root canal treated teeth
- •Teeth with a PAI score <3
- •Developmental anomalies
- •Advanced periodontal destruction
- •Internal/external resorption
- •History of trauma
- •Patients with systemic diseases
- •Pregnant or breastfeeding patients
研究组 & 干预措施
MAF 40 group
Participants receive regenerative endodontic treatment with apical preparation completed to ISO size 40.
干预措施: Regenerative Endodontic Treatment (Procedure)
MAF 80 group
Participants receive regenerative endodontic treatment with apical preparation completed to ISO size 80.
干预措施: Regenerative Endodontic Treatment (Procedure)
结局指标
主要结局
Primer success
时间窗: 6 months and 12 months
Primer success is evaluated based on the absence of clinical symptoms and radiographic healing of the periapical lesion.
Secondary success
时间窗: 6 months and 12 months
Secondary success was defined as the recovery of pulp sensibility, evaluated using cold and electric pulp tests during follow-up examinations.
次要结局
- Postoperative Pain(baseline, day 1, day 2, and day 7 after treatment)
- Periapical Lesion Area(Baseline, 6 months, 12 months)
- Mean Gray Value(Baseline, 6 months, 12 months)
- Fractal Dimension(Baseline, 6 months, 12 months)