Using Platelet-rich Fibrin in Regenerative Endodontic Treatment in Mature Permanent Teeth
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Clinical assessment
研究概览
简要总结
This study aims to evaluate the antibacterial effects of injectable platelet-rich fibrin (i-PRF) in vitro, and to assess the clinical and radiographic outcomes of using advanced platelet-rich fibrin (A-PRF+) and i-PRF in regenerative endodontic treatment of mature permanent teeth with necrotic pulp. The study will compare the effectiveness of PRF-based treatment with conventional blood clot-based regenerative endodontics.
详细描述
This study aims to evaluate the antibacterial effects of injectable platelet-rich fibrin (i-PRF) in vitro, and to assess the clinical and radiographic outcomes of using advanced platelet-rich fibrin (A-PRF+) and i-PRF in regenerative endodontic treatment of mature permanent teeth (single-rooted teeth with necrotic pulp, with or without periapical pathology). The study will compare the effectiveness of PRF-based treatment with conventional blood clot-based regenerative endodontics.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants had a single-rooted tooth with necrotic pulp (negative response to electric pulp testing), with or without periapical pathology (acute apical periodontitis of pulpal origin, chronic periapical periodontitis, periapical abscess with sinus, periapical abscess without sinus), and gave their consent to participate in the study.
排除标准
- •Study samples will be excluded if any of the following criteria are met:
- •The tooth has had previous endodontic treatment.
- •The root apex is not fully developed, or there is root resorption/cracking/fracture.
- •The tooth has severe tooth loss and is indicated for extraction, or is indicated for restoration with a post or cast core after endodontic treatment.
- •The root canal is calcified.
- •The root canal curvature is greater than 25º.
- •The tooth has a periapical cyst or is associated with a jawbone cyst.
- •The tooth has a periodontal pocket deeper than 4 mm.
- •The tooth has no occlusal contact.
- •The patient is pregnant.
- •The patient has diabetes or HIV or other immunocompromised conditions.
结局指标
主要结局
Clinical assessment
时间窗: 1 month, 3 months, 6 months, 9 months, 12 months.
* Clinical success: Absence of all the following symptoms (swelling, sinus tract, pain on percussion/bite, tooth mobility, and positive pulp sensibility). * Clinical failure: Presence of any one of the above symptoms.
Radiographic assessment
时间窗: 1 month, 3 months, 6 months, 9 months, 12 months
* Radiographic success: Absence or reduction of periapical pathology, measured by change in lesion size on periapical radiographs/CBCT. * Radiographic failure: Persistence or progression of periapical pathology, measured by change in lesion size on periapical radiographs/CBCT.
次要结局
未报告次要终点
研究者
Tran Thi Tuong Vi
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City