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临床试验/NCT05676268
NCT05676268已完成不适用

Clinical and Radiographic Outcomes of Implant-supported Full-ceramic Partial Fixed Dental Prostheses With Cantilever Extension: A Proof of Principle Study With a Follow-up of at Least 1 Year

University of Bern1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Implant survival rate

研究概览

简要总结

To report the clinical and radiographic outcomes of implant-supported fixed dental prostheses with full-ceramic cantilever extensions (FDPCs) after a function time ≥ 12 months.

详细描述

Patients with full ceramic FDPCs in anterior and posterior areas will be clinically and radiographically re-evaluated. Mesial and distal radiographic marginal bone levels (mBLs) from baseline (i.e. delivery of FDPC) to the follow-up examination were calculated and compared between implant surfaces adjacent to and distant from the cantilever extension. Implant survival rate (%), pocket probing depth (PPD), presence/ absence of bleeding on probing (BoP) and presence/absence of mechanical/technical and biological complications were recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged ≥18 years
  • Written informed consent
  • Patients with systemic health or controlled medical conditions
  • Patients with healthy or treated periodontal conditions
  • Patients enrolled in regular supportive periodontal therapy (SPT)
  • Patients without clinical signs of bruxism and/or oral parafunctions
  • 2 osseointegrated dental implants in the canine or posterior areas of maxilla and mandible following transmucosal placement and healing of 3-6 months
  • Tissue level solid-screw implants with a sand-blasted and acid- etched (SLA) surface with an endosseous diameter of 3.3, 4.1 or 4.8 mm, a length of 8, 10 or 12 mm, a shoulder diameter of 4.8 mm and a supracrestal machined neck with a height of 1.8 or 2.8 mm (Straumann® Dental Implant System, Institut Straumann AG, Basel, Switzerland)
  • Full-ceramic
  • Utilization of prefabricated titanium abutments
  • Cemented (3M™ ESPE Ketac™ Cem, Seefeld, Germany) or screw-retained fixed dental prostheses with a mesial or distal cantilever extension (FDPCs)
  • Cantilever extension corresponding to 1 premolar unit (i.e., 6-7 mm)
  • Absence of occlusal contacts or guidance on the cantilever extension at baseline
  • Opposing dentition consisting of natural teeth or fixed or removable prosthetic restorations
  • Availability of a periapical radiograph at baseline (i.e. FDPC delivery)
  • Availability of PPD measurements (mm) taken at baseline at 4 sites/implant with a graduated Michigan periodontal probe (Deppeler SA, Rolle, Switzerland)
  • Availability of BoP measurements (%) (Lang et al., 1986) taken at baseline at 4 sites/implant with a graduated Michigan periodontal probe (Deppeler SA, Rolle, Switzerland).

排除标准

  • Untreated or active periodontal diseases
  • Immediate implant placement (i.e., Type I implant placement according to Hämmerle et al., 2004)
  • FDPCs in the aesthetic zone (i.e., replacement of maxillary or mandibular incisors)
  • FDPCs supported by hollow-screw and hollow-cylinder implants

结局指标

主要结局

Implant survival rate

时间窗: 12 months

Percentage of dental implants present at follow-up visit

次要结局

  • Peri-implant marginal bone level changes(12 months)
  • Number of technical complications(12 months)
  • Number of mechanical complications(12 months)
  • Number of Biological complications(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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