Comparison Between MTA and TotalFill® BC-RRM Fast Set Putty for Retrograde Filling in Apical Surgery: Randomized Non-inferiority Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Periapical lesion healing assessed by CBCT using 3D PENN criteria.
研究概览
简要总结
The aim of this study is to compare two biomaterials used for retrograde obturation during apical surgery. This surgery is indicated in healthy patients when root canal treatment (endodontics) has failed to eliminate a periapical lesion (a persistent infection in the root of the tooth).
The main question it seeks to answer is:
- Is TotalFill® BC-RRM Fast Set Putty more effective than ProRoot® MTA in periapical surgery in terms of the degree of healing?
The study will include patients who need this type of surgery and meet specific clinical criteria. Each patient will have one of the two materials applied as part of the standard surgical procedure. Subsequently, clinical and radiographic follow-up will be performed to assess the degree of healing of the periapical lesion with a 1-year follow-up.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age.
- •Patients giving consent for surgical intervention, for radiographic evaluation with HCT preoperatively and at least one more time after 12 months, and for participation in the study.
- •Medical history not relevant to the diagnosis and surgical treatment (ASA classes I and II).
- •Previous non-surgical endodontic treatment or retreatment with clinical and/or radiographic evidence of persistence or recurrence of apical periodontitis. The minimum time since the last non-surgical treatment shall be 6 months.
- •Teeth not previously treated with periapical surgery.
- •Lesion less than 10 mm in diameter.
- •Restorable teeth.
- •Periodontally sound teeth or teeth with treated periodontal pathology (mobility 1, probing depth < 5mm).
- •Teeth with no root resorption.
排除标准
- •Teeth with vertical fracture.
- •Teeth with root perforation.
- •Lesions associated with an apicomarginal defect.
- •Tunnel lesions.
- •Technical errors during surgery that may compromise the outcome.
- •Lack of integrity of the dentine walls surrounding the retrograde filling detected with the endoscope.
- •Wound dehiscence.
- •Postoperative infection.
- •Follow-up less than 12 months.
研究组 & 干预措施
BioCeramic Root Repair Material Fast Set Putty (BCRRM)
Patients undergoing apical surgery treated with retrograde obturation using BioCeramic Root Repair Material Fast Set Putty (BCRRM).
干预措施: BioCeramic Root Repair Material Fast Set Putty. (Device)
MTA (Mineral Trioxide Aggregate)
Patients undergoing apical surgery treated with retrograde obturation using Mineral Trioxide Aggregate (MTA).
干预措施: Mineral Trioxide Aggregate (Device)
结局指标
主要结局
Periapical lesion healing assessed by CBCT using 3D PENN criteria.
时间窗: 12 months post-surgery
Periapical healing will be evaluated using cone-beam computed tomography (CBCT) at 12 months after periapical surgery. Lesion volume or dimensions will be measured and the percentage of reduction will be calculated. Based on these measurements, healing will be classified according to the 3D PENN CBCT criteria into complete, limited, uncertain, or unsatisfactory healing. A comparison will be made between ProRoot® MTA versus TotalFill® BC-RRM Fast Set Putty as retrograde filling materials.
次要结局
未报告次要终点
研究者
David Peñarrocha Oltra
Associate Professor, PhD
University of Valencia