Optimizing Pulp Management Strategies for Autotransplantation of Fully Developed Third Molars: A Three-Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Success Rate
研究概览
简要总结
This study aims to find the best way to use your own healthy wisdom tooth to replace the bad tooth. After transplantation, how to manage the "tooth nerve" (dental pulp) inside the tooth is a key question. Currently, doctors have three different management strategies, but it is not clear which one is most beneficial for long-term success.
This study will compare these three strategies:
Performing standard root canal treatment (removing the tooth nerve) a few weeks after transplantation.
Performing a special procedure to treat and fill the root tip during the transplant surgery, followed by root canal treatment later.
Simply trimming the root tip during the transplant surgery, hoping to preserve the vitality of the tooth nerve and thereby avoid subsequent root canal treatment.
If you agree to participate, you will be randomly assigned to one of these groups to receive treatment. Afterwards, we will need to schedule regular check-ups for you over a period of 5 years (including X-rays and examinations) to monitor the healing of the transplanted tooth, check for any problems, and assess the status of the tooth nerve.
Your participation will help us identify the most effective and long-lasting treatment method, thereby benefiting future patients in similar situations.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-40 years.
- •Requires extraction of a non-restorable first or second molar AND possesses a fully developed, morphologically healthy ipsilateral third molar as a donor tooth.
- •Willing and able to provide written informed consent.
排除标准
- •Presence of acute infection or insufficient bone volume at the recipient site.
- •Donor tooth exhibits caries, periapical pathology, or periodontal disease.
- •Uncontrolled systemic disease (e.g., diabetes, immunosuppression), pregnancy, or lactation.
- •Smoking habit of >10 cigarettes per day.
- •Inability or unwillingness to comply with the long-term follow-up schedule.
结局指标
主要结局
Success Rate
时间窗: 1 year and 5 years postoperatively
Comprehensive success defined as the transplanted tooth being present, functional, asymptomatic (no pain on percussion, no sinus tract), with healthy gingiva, and no radiographic evidence of progressive inflammatory root resorption or periapical radiolucency.
Survival Rate
时间窗: 1 year and 5 years postoperatively
The proportion of transplanted teeth remaining in the oral cavity and functional.
Incidence of Inflammatory Root Resorption
时间窗: 1 year and 5 years postoperatively
The proportion of transplanted teeth exhibiting radiographic signs of inflammatory root resorption (periapical radiolucency adjacent to the root surface with loss of lamina dura) on periapical radiograph or CBCT.
次要结局
- Pulp Revascularization/Survival (RER Group)(Postoperative 3, 6, 12 months, and then annually up to 5 years)
- Radiographic Periodontal Ligament Healing(Postoperative 3, 6, 12 months, and then annually up to 5 years)