Research on the Development and Clinical Evaluation of Biomimetic Abutments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in soft tissue contour
研究概览
简要总结
This study aims to evaluate the clinical effectiveness of biomimetic abutments in implant restoration.
详细描述
The biomimetic healing abutments were placed during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.
To assess soft tissues, digital models were collected in STL files at five time points: before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration. These models were analyzed using 3D software for model matching and measurement based on CBCT, focusing on the changes on soft tissue height, width, and volume.
Hard tissue evaluation was conducted through periapical radiographs taken at three time points: immediately after restoration, six months after restoration, and 12 months after restoration.
Additionally, general clinical conditions were assessed at the same three time points, evaluating parameters such as food impaction, plaque index, and gingival index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 25 and 65 years old
- •had one single edentulous site
- •implant embedded healed and required secondary surgery to expose
- •good treatment compliance and could attend follow-up appointment regularly
排除标准
- •soft tissue grafting was needed
- •severe acute or chronic periodontitis
- •heavy smoking habit (> 10 cigarettes/day)
- •poor oral hygiene
结局指标
主要结局
Changes in soft tissue contour
时间窗: before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration
Changes of soft tissue contour in height, width, and volume by matching digital models at different treatment stages.
次要结局
- Changes in hard tissue contour(immediately after restoration, six months after restoration, and 12 months after restoration)
- Food impaction(immediately after restoration, six months after restoration, and 12 months after restoration)
- Plaque index(immediately after restoration, six months after restoration, and 12 months after restoration)
- Gingival index(immediately after restoration, six months after restoration, and 12 months after restoration)
研究者
Cheng Hui
Professor of Prosthodontics
Stomatological Hospital Affiliated with Fujian Medical University