Effect of the Intaglio Surface of Full-arch Implant-supported on Marginal Bone Level: A Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluation of the depth of the shape of the intaglio surface of full-arch and its association with increased marginal bone level.
研究概览
简要总结
The purpose of the study is to determine if there is an association between the intaglio shape of full-arch implant-supported prosthesis and marginal bone level around implants. The intaglio shape can be present as concave or convex and, depending on that, it can lead to more plaque accumulation on the fitting surface of the prosthesis.
Null Hypothesis (H0): Full-arch implant supported prosthesis with an increased depth of the intaglio shape demonstrate similar marginal bone levels as prosthesis with a reduced depth of the intaglio surface.
Alternative Hypothesis (H1): Full-arch implant supported prosthesis with an increased depth of the intaglio shape demonstrate increased/reduced marginal bone levels compared to prosthesis with a reduced depth of the intaglio surface.
详细描述
The investigators will review dental records from the university and call eligible individuals for an appointment. During the research visit, the investigators will take new x-rays for marginal bone level assessment and a digital scan of the prosthesis to assess the shape of the intaglio. Also, remove the prosthesis, perform clinical measurements and collect plaque samples from the prosthesis and the implant sulcus. then, implants and prosthesis will be cleaned and placed in position.
The study will have only one appointment where every measurement will be assessed in this visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •≥ 18 years old;
- •Rehabilitated with a full-arch screw-retained supported prosthesis in the maxilla, in function for at least 1 year;
- •Good overall health (ASA I or ASA II).
排除标准
- •Individuals with motricity problems who cannot clean the prosthesis;
- •Patients treated or maintained in centers outside the University of Pittsburgh;
- •Incomplete dental records;
- •Misfit at the prosthesis-implant interface;
- •Cemented prosthesis;
- •Individuals rehabilitated with over dentures;
- •Individuals with uncontrolled chronic diseases or immunocompromised;
- •Pregnant Patients.
研究组 & 干预措施
Patients Rehabilitated with full-arch implant-supported prosthesis
All patients that are rehabilitated with full-arch implant-supported prosthesis
干预措施: Full arch (Device)
结局指标
主要结局
Evaluation of the depth of the shape of the intaglio surface of full-arch and its association with increased marginal bone level.
时间窗: The measurements will be assessed during the unique visit of the patient in the study.
After the prosthesis is scanned, and evaluation of the 3D file of the prosthesis will occur. A virtual line will be traced between the Buccal to the Palatal/Lingual flange of the prosthesis. In the middle point of this line, a perpendicular line will be traced in direction of the fitting surface of the prosthesis, intaglio, and this distance will be measured in mm.
次要结局
- Probing Depth of the implants(The measurements will be assessed during the unique visit of the patient in the study.)
- Bleeding on Probing of the implants(The measurements will be assessed during the unique visit of the patient in the study.)
- Modified Plaque Index(The measurements will be assessed during the unique visit of the patient in the study.)
- Marginal Recession(The measurements will be assessed during the unique visit of the patient in the study.)
- Suppuration(The measurements will be assessed during the unique visit of the patient in the study.)
- Keratinized mucosa width(The measurements will be assessed during the unique visit of the patient in the study.)
研究者
Andrea Ravida
Assistant Professor
University of Pittsburgh