NCT05676268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

January 2, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

December 22, 2022

Last Update Submit

January 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Implant survival rate

    Percentage of dental implants present at follow-up visit

    12 months

Secondary Outcomes (4)

  • 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

Study Arms (1)

Patients with oral implants supporting full ceramic fixed dental prostheses

Procedure: Implant-supported fixed dental prostheses with cantilever extension

Interventions

Healthy patients in need of replacement of missing teeth with dental implants supporting partial fixed dental prostheses with cantilever extensions

Patients with oral implants supporting full ceramic fixed dental prostheses

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with missing teeth rehabilitated with dental implants supporting partial fixed dental prostheses with cantilever extensions

You may qualify if:

  • 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
  • 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)
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology, University of Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Prosthesis FailurePeri-Implantitis

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Andrea Roccuzzo

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 9, 2023

Study Start

January 2, 2023

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations