Implant-supported Fixed Dental Prostheses (FDPs) With Cantilever Extension

Recruiting

• Conditions: Peri-Implantitis; Dental Implant Failed; Prosthesis Failure
• Interventions: Procedure: Implant-supported fixed dental prostheses with cantilever extension

• Registration Number: NCT05676268
• Lead Sponsor: University of Bern

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2022-12-22
• Study Start: 2023-01-02
• Study First Posted: 2023-01-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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).

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with oral implants supporting full ceramic fixed dental prostheses	Implant-supported fixed dental prostheses with cantilever extension	-

Primary Outcome Measures

Name	Time	Method
Implant survival rate	12 months	Percentage of dental implants present at follow-up visit

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Periodontology, University of Bern; 🇨🇭 Bern, Switzerland