A Histomorphometric Analysis of Bone Formation With Two Different Bone Graft Material in Adult Patients Required Socket Preservation After Tooth Extraction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 82
- 试验地点
- 4
- 主要终点
- Evaluation of quantify the new bone formation via histomorphometric analysis following tooth extraction with GBR procedure.
研究概览
简要总结
This is a prospective, multicentre, parallel-group, randomized controlled, single blinded (participant) trial aims to compare the investigational medical device with standard of care in dental treatment addressing the preservation of bone loss after tooth extraction.
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 (Participant)
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
- •Patients over 18 years old with full legal capacity, male and female;
- •Patients with ability to understand the proposed surgical treatment and to understand and sign the informed consent;
- •Patients who are willing and able to comply with scheduled visits, treatment and other trial procedures;
- •Patients who respect the follow-up recalls.
排除标准
- •Presence of bone lesions;
- •Patients with alcohol or substance abuse;
- •Patients with smoking habits (more than 10 cigarettes per day);
- •Patients presenting physical and/or mental handicap that impede an adequate oral hygiene;
- •Pregnant or breast feeding women;
- •Patients currently participating in any other clinical investigation.
研究组 & 干预措施
Interventional arm
The intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places investigational device, and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed.
干预措施: Tooth extraction and GBR procedure (Device)
Standard of care arm
The intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places standard of care device and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed.
干预措施: Tooth extraction and GBR procedure (Device)
结局指标
主要结局
Evaluation of quantify the new bone formation via histomorphometric analysis following tooth extraction with GBR procedure.
时间窗: 6 months
A new bone formation assesses via histomorphometric evaluation.
次要结局
- Evaluation of (serious) adverse events (S)AEs.(13 months)