Clinical trial NCT05676268: Implant-supported Fixed Dental Prostheses (FDPs) With Cantilever Extension
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Implant Failed
Prosthesis Failure
Peri-Implantitis
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with missing teeth rehabilitated with dental implants supporting partial fixed dental prostheses with cantilever extensions

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implant survival rate
timeFrame: 12 months
Secondary outcomes:
measure: Peri-implant marginal bone level changes
timeFrame: 12 months
measure: Number of technical complications
timeFrame: 12 months
measure: Number of mechanical complications
timeFrame: 12 months
measure: Number of Biological complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Periodontology, University of Bern
Study officials:
affiliation: University of Bern
name: Andrea Roccuzzo
role: PRINCIPAL_INVESTIGATOR
References: