Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical assessment of the status of osseointegration
研究概览
简要总结
The aim of this study was to investigate the therapeutic effect of sloped dental implants. It can reduce the need of osteoectomy, reduce discomfort of procedures, and is easier for maintenance.
详细描述
20 OsseoSpeed ™ Profile EV and 20 OsseoSpeed ™ EV groups will be randomly implanted into the oblique edentulous ridges of subjects, and the treatment response will be monitored for 3 years. The implantation area will be randomly divided into two groups, One group was treated with OsseoSpeed ™ Profile EV (sloped group) and the other group was treated with OsseoSpeed ™ EV (control group). The same patient had the same implant as the same quadrant.
The patient will be followed up regularly for follow-up, followed by clinical attachment level, probing depth, bleeding on probing, keratinized gingival width (Keratinized gingiva), mobility (mobility) and other clinical indicators of the measurement, regular dental radiography, gingival crevicular fluid (GCF) collection and bone integration measurement.
After six months of implantation, prosthesis will delivered and loaded functionally, and regular follow-up will be arranged. In each time of follow-up, examination will be carried out with regards to periodontal pocket depth, clinical attachment height, periodontal bleeding index, keratinized gingival width, and other clinical indicators of the measurement, at the end of the experiment, that is, after three years, and then a dental root film irradiation, GCF collection and osseointegration measurement.
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
- Double (Investigator, Outcomes Assessor)
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
- 否
入选标准
- •20-80 years old with appropriate oral cleaning ability; the computer tomography shows > 1 mm buccolingual discrepancy of alveolar ridge height; no generalized periodontitis, or had history of periodontitis but has been completed treatment; no major systemic infection or major systemic illness; not taken antibiotics in the past two weeks Not pregnant or breastfeeding
排除标准
- 未提供
研究组 & 干预措施
Control
Installation of conventional design dental implant
干预措施: Control (Device)
Sloped
Installation of sloped design dental implant
干预措施: Sloped (Device)
结局指标
主要结局
Clinical assessment of the status of osseointegration
时间窗: up to 3 years
radiographic bone level, bone consolidation index (ISQ)
次要结局
- The peri-implant health(1 year, 2 years, 3 years)
- The health status of adjacent teeth(0 day, 6 months, 1 year, 2 years, 3 years)
- Biomarkers in the gingival crevicular fluid of adjacent teeth(0 day, 6 months, 1 year, 2 years, 3 years)
- Biomarkers in the gingival crevicular fluid of dental implant(1 year, 2 years, 3 years)