Facial Mucosal Level Determinants for Single Immediately Placed Implants Evaluated by Novel Ultrasonography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Mucosal recession on the tested implant
研究概览
简要总结
A single center, prospective clinical trial is planned to investigate the effect of different emergence angles of implant restorations on peri-implant soft tissue recession and implant marginal bone loss.
The primary outcome is to systematically evaluate the association of implant-, peri-implant tissue-, and restoration-related factors with facial mucosal level changes.
详细描述
Facial mucosal recession still poses a threat to long-term success of implant therapy especially esthetic appearance. To study the timing and extent of mucosal recession and the associated risks, a prospective study is strategically important. This will allow the collection of valuable longitudinal data about facial mucosal level changes, peri-implant tissue dimensions, and implant/restoration parameters that are considered critical for determining the mucosal level. Forty adult patients who meet the inclusion criteria will be recruited to participate in this study. Patients that had an implant crown placed a minimum time frame of 6 months and have existing relevant clinical data (mucosal level and thickness, radiographs, cone beam computed tomogram (CBCT) scans, study casts and intra-oral photographs) at baseline and if possible at other follow-up visits will be invited to participate in this study. Patients that volunteer to be screened will not be examined for study eligibility until an informed consent has been obtained. Patient information will be protected according to HIPAA. The enrolled subjects will have research measurements taken, an ultrasound scan, intraoral photos and an impression of the arch including the study implant. One dental cone beam computed tomography (CBCT) scan will be taken to evaluate the implant position in relation to the alveolar ridge and to evaluate relative bone quality. The primary outcome will analyze the changes in the facial mucosal level, by superimposing the digital images of the stone models that were taken previously. On ultrasound images, peri-implant tissue parameters, implant positions, restoration contour, etc., will be measured and recorded. The primary outcome will then be equated with clinical and radiographic readings, and ultrasound parameters, along with timing of provisionalization or final restoration, in regression analysis to identify factors related to facial mucosal recession.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Subjects 18 years old or older
- •One immediate maxillary implant placement with 2 adjacent neighboring teeth
- •Available pre-surgery model
- •Radiographic documentation (either peri-apical x-rays or CBCT)
- •Have final restoration for at least 6 months.
排除标准
- •Are under 18 years of age.
- •Are unwilling or unable to read and sign this informed consent document.
- •Have any medical conditions that we believe may influence the outcome of the study.
结局指标
主要结局
Mucosal recession on the tested implant
时间窗: At least 12 months following implant placement.
It is a one-time measurement (this study is only one-time visit) within the study timeframe, measured from a reference, adjacent tooth landmark, to the mucosal margin of the implant.
次要结局
- Crown contour of the tested implant(At least 12 months following implant placement.)
研究者
Hsun-Liang Chan
Clinical Assistant Professor
University of Michigan
