A Histomorphometric Analysis of Bone Formation With Two Different Bone Graft Material in Adult Patients Required Socket Preservation After Tooth Extraction
概览
- 阶段
- 不适用
- 干预措施
- Tooth extraction and GBR procedure
- 疾病 / 适应症
- Socket Preservation
- 发起方
- Medical Inventi S.A.
- 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.
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
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.
研究者
入排标准
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
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
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)