Influence of Implant Crown Transmucosal Contour Design on Soft and Hard Tissue Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Gum tissue thickness
研究概览
简要总结
This study will evaluate how the crown's shape under the gums will influence the gum tissue around dental implants.
详细描述
This research is studying the transmucosal contour, or shape of crowns (white-colored tooth structure that sits above the gum) under the gums on dental implants. Participants will be randomly selected for the dental implant crown to be designed with either a straight or concave transmucosal contour, and followed up on for 1 year after crown delivery.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be a current participant of HUM00208140 main study
- •Have a dental implant that is ready to be restored (placed at least 3 months ago and healing is adequate)
排除标准
- •The dental implant crown was already delivered.
研究组 & 干预措施
Straight transmucosal contour
Implant crown will be designed with a straight transmucosal contour
干预措施: Implant crown delivery (Procedure)
Concave transmucosal contour
Implant crown will be designed with a concave transmucosal contour
干预措施: Implant crown delivery (Procedure)
结局指标
主要结局
Gum tissue thickness
时间窗: 6 months and 12 months after crown delivery
Measured from intraoral scan in mm
Marginal bone loss around dental implant
时间窗: 6 months and 12 months after crown delivery
Measured from radiographs in mm
Gingival margin height
时间窗: 6 months and 12 months after crown delivery
Measured from intraoral scan in mm
Amount of keratinized gingiva
时间窗: 6 months and 12 months after crown delivery
Measured clinically in mm
次要结局
未报告次要终点
研究者
Muhammad Saleh
Clinical Assistant Professor, Periodontics and Oral Medicine
University of Michigan