Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction: a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- M3 Health
- 入组人数
- 150
- 主要终点
- Rate of newly formed bone tissue, soft tissue and residual bone graft material
研究概览
简要总结
The goal of this clinical trial is to compare the maintenance of socket volume in the groups treated by a resorbable regenerative membrane (Plenum® Guide) covered or not with mucous tissue, with control without treatment. The main question it aims to answer is the effectiveness of the Plenum® Guide membrane in the process of guided bone regeneration, exposed or not, through the preservation and neoformation of bone tissue in the tooth extraction socket procedures.
详细描述
Patients will be submitted to tooth extraction, the surgical procedure of guided bone regeneration using regenerative membranes and synthetic bone graft, and subsequent installation of dental implants. The 05 groups will be compared to observe if the proposed medical devices effectively will maintain the socket's bone volume during the healing phase before the installation of the dental implants (1. socket filled only with clot, 2. socket associated with exposed absorbable membrane, 3. socket associated with covered absorbable membrane, 4. socket filled with synthetic bone graft and covered absorbable membrane, 5. socket filled with synthetic bone graft and exposed absorbable membrane).
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
- None
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
- •Possess the four bone walls after the extraction procedure;
- •Over 18 years old;
- •And who have signed the TCLE.
排除标准
- •Uncontrolled systemic impairments;
- •Teeth in areas of tumor lesions;
- •Acute infectious processes;
- •Deciduous dental elements;
- •Untreated periodontal problems;
- •Radiated in the head or neck region;
- •Allergy to any component used in the research;
- •Psychological disorders;
- •Pregnant and lactating women.
研究组 & 干预措施
socket
Tooth extraction socket filled only clot.
干预措施: Tooth extraction (Procedure)
Socket filled with synthetic bone graft and exposed absorbable membrane
Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region.
干预措施: Plenum® Guide (Device)
Socket filled with synthetic bone graft and exposed absorbable membrane
Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region.
干预措施: Plenum® Oss (Device)
Socket filled with synthetic bone graft and exposed absorbable membrane
Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region.
干预措施: Tooth extraction (Procedure)
Socket associated with exposed absorbable membrane
Socket filled with clot and covered with the Plenum® Guide membrane exposed in the intraoral region.
干预措施: Plenum® Guide (Device)
Socket associated with exposed absorbable membrane
Socket filled with clot and covered with the Plenum® Guide membrane exposed in the intraoral region.
干预措施: Tooth extraction (Procedure)
Socket associated with covered absorbable membrane
Socket filled with clot and covered with the Plenum® Guide membrane and covered by mucosa (gingival tissue) in the intraoral region.
干预措施: Plenum® Guide (Device)
Socket associated with covered absorbable membrane
Socket filled with clot and covered with the Plenum® Guide membrane and covered by mucosa (gingival tissue) in the intraoral region.
干预措施: Tooth extraction (Procedure)
Socket filled with synthetic bone graft and covered absorbable membrane
Socket filled with synthetic bone graft and the Plenum® Guide membrane covered by gingival tissue in the intraoral region.
干预措施: Plenum® Guide (Device)
Socket filled with synthetic bone graft and covered absorbable membrane
Socket filled with synthetic bone graft and the Plenum® Guide membrane covered by gingival tissue in the intraoral region.
干预措施: Plenum® Oss (Device)
Socket filled with synthetic bone graft and covered absorbable membrane
Socket filled with synthetic bone graft and the Plenum® Guide membrane covered by gingival tissue in the intraoral region.
干预措施: Tooth extraction (Procedure)
结局指标
主要结局
Rate of newly formed bone tissue, soft tissue and residual bone graft material
时间窗: 4 months after extraction
immunohistochemical analyzes of histological sections
Rate of alveolar repair
时间窗: Comparison of exams obtained in the preoperative period, immediate postoperative period (7 days) and late postoperative period (3 months)
Accessed via cone beam computed tomography
次要结局
未报告次要终点