Randomized Controlled Clinical Trial (RCT) of Implant-retained Monolithic Chairside-made CAD-CAM Hybrid Abutment Single Crowns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- survival
研究概览
简要总结
Newly available ceramic CAD-CAM blocs containing a screw channel for chairside-made crowns to be adhesively cemented to a TiBase abutment and screw-retained to an implant are appealing to the clinician, considering the time efficiency (one appointment) and overall lower costs as no dental laboratory is involved. The hypotheses are that the biological (BOP, PD, PCR, implant bone level) and mechanical outcomes (fracture, loss of retention, wear) are equivalent to implant screw-retained Porcelain-Fused-to-Metal (PFM) crowns over a 5 year observation time.This RCT will provide key information as to the cost/benefit, suitability and/or limitations of these chair-side hybrid-abutment crowns in the posterior region.
详细描述
This RCT involves the University of Geneva Dental School and four private practices for which the Geneva Hospital Ethic Committee's approval is required. Patients in need for replacement of single unit posterior teeth will be recruited at the Dental School as well as in the 5 private practices based on specific selection criteria. Patients will be randomly assigned to a restorative group using a computer-generated random number table for allocation.
The CAD-CAM blocs containing a screw channel for implant-retained chairside-made single-unit hybrid-abutment crowns are 1) Lithium-disilicate glass-ceramic (e.max CAD) (G1) and 2) feldspath-ceramic infiltrated by polymer (Enamic) (G2). The CAD-CAM crowns are adhesively cemented to titanium base abutments (Ti-base) and screw-retained to Titanium implants (Straumann Standard Plus) in the premolar (RN) and molar region (WN). Controls are screw-retained PFM crowns (G3). The number of crowns in each group is N=30 (15 molars and 15 premolars) which gives a total of 90 crowns for this study.
Participants are recalled after 1 week-10 days after crown insertion (baseline, T0) and then yearly during 5 years (T1-T5). Digital X-Rays are taken at T0, T1, T3 and T5 with repositionable individual resin bite registrations.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Absence of relevant medical condition
- •Need for a single crown on implant in the molar or premolar region with existing adjacent and antagonist teeth
- •No active periodontal or pulpal diseases
- •Teeth with good restorations
- •Straumann regular (premolar) and wide neck (molar) implants, osseo-integrated for a minimum of 2 months and facial keratinized mucosa width of at least 2 mm
- •Patient agrees to return for follow-up examinations during 5 years
- •Patient agrees to immediately inform the operator in case of problem
排除标准
- •evidence of bruxism
- •2 adjacent implants
- •implants placed of-axis
结局指标
主要结局
survival
时间窗: 5 years
The primary aim is to monitor and compare the survival of the two CAD-CAM hybrid abutment crown materials with that of PFM implant screw-retained crowns in the posterior region over a period of 5 years. The survival data is subdivided into "absolute failures" needing replacement of the restoration and "relative failures" which include complications that could be repaired.
次要结局
- Occlusal surface wear(5 years)
研究者
Susanne Scherrer
Associate Professor, Head of Biomaterials
University of Geneva, Switzerland