Influence of Platform-switching on Bone Level Alterations: a 3 Year RCT.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Søren Jepsen
- 入组人数
- 25
- 主要终点
- Change of vertical implant bone level
研究概览
简要总结
The concept of platform-switching has been introduced to implant dentistry based on clinical observations of reduced periimplant crestal bone loss. However, published available data are controversial and most studies are limited to 12 months. The aim of the present RCT was to test the hypothesis that platform-switching has a positive impact on crestal bone level changes after 3 years.
详细描述
Two implants with a diameter of 4 mm were inserted crestally in the posterior mandible of 25 subjects. After three months of submerged healing, single-tooth crowns were randomly placed, either with (3.3mm platform, test) or without platform-switching (4mm platform, control). Patients were followed up at short intervals for monitoring of healing an oral hygiene. Statistical analysis for the influence of time and platform-type on bone levels employed the Brunner-Langer Model.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •good general health
- •edentulous gap in the posterior mandible for placement of 2 implants
- •sufficient bone height above the alveolar nerve for placement of implants with a height of 9.5mm
- •bone width for placement of implants with diameter of 4mm
- •at least 4mm keratinized mucosa
- •medium or a thick soft tissue biotype
排除标准
- •infectious disease
- •diabetes or osteopathy
- •active periodontitis
- •medication influencing bone metabolism
- •lactating or pregnant women
研究组 & 干预措施
platform-matched implant
platform-matched implant
干预措施: platform-shifted implant (Device)
platform-switched implant
platform-switched implant
干预措施: platform-shifted implant (Device)
结局指标
主要结局
Change of vertical implant bone level
时间窗: Implant insertion (baseline), 3 months (reopening), 4 months (crown mounting), 12, 25 and 38 months
次要结局
- Plaque(baseline, 4, 8, 12, 25, 38 months)
- probing depths(4, 8, 12, 25, 38 months)
- Bleeding(baseline, 4, 8, 12, 25, 38 months)
研究者
Søren Jepsen
Professor Dr.med Dr. med.dent MS, Chair
University Hospital, Bonn