Healing Outcomes of Peri-implant Soft Tissues With Customized Healing Abutments in Immediate and Delayed Implant Placement Protocols: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Soft tissue healing progress
研究概览
简要总结
The purpose of this study is to compare how well our research participants heal with two different kind of healing abutments used. One is pre-fabricated, meaning it is made to fit anyone, and the other is customized to fit the subject specifically. Much of what will occur is 'standard of care' meaning it is part of a subject's typical dental treatment and the research team wants to just look at the data for this research study, as well.
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
- •Patients of record at TUSDM who are over 18 years of age
- •Implants placed as immediate or delayed with a torque of ≥ 35 Ncm eligible to receive a healing abutment left exposed to heal;
- •Site of implant placement not requiring soft tissue augmentation at the time of healing abutment placement
- •Sufficient mesial, distal space (7mm for anterior teeth and premolar and 8-9mm for molars) and interocclusal space (7-8mm for screw and cement retained crowns) for definitive restorations (12).
排除标准
- •Unable to give consent
- •active periodontal disease
- •Heavy smoker
- •Active infection at implant site
研究组 & 干预措施
Control: Pre Fabricated Healing Abutment
Subjects that are randomized into the control group will have a pre-fabricated healing abutment used.
干预措施: Healing Abutment- pre fabricated (Device)
Investigational: Customized Healing Abutment
Subjects that are randomized into the control group will have a customized healing abutment used.
干预措施: Healing Abutment- customized (Device)
结局指标
主要结局
Soft tissue healing progress
时间窗: 3 months
Clinical Evaluation of Soft Tissue Healing; the clinician will perform intraoral examination on tissue color, contour, signs of inflammation, presence of keratinized tissue and soft tissue integration around the healing abutment. These are all visual observations and will be recorded as Yes/No.
次要结局
- Functional outcome of gingival appearance(3 months)
- Functional outcome of implant esthetic(3 months)