Peri-Implantitis Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 31, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Periodontology, University of Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
University of Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implant survival rate | Percentage of dental implants present at follow-up visit | 12 months | |
Secondary | Peri-implant marginal bone level changes | 12 months | ||
Secondary | Number of technical complications | 12 months | ||
Secondary | Number of mechanical complications | 12 months | ||
Secondary | Number of Biological complications | 12 months |
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