Clinical Performance of Dual-cantilevered Single-implant Bridge

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bern

About this trial

The study aims to evaluate the clinical performance (implant and prosthetic survival/ success rates) of a novel implant-supported fixed dental prosthesis design: the dual-cantilevered single implant bridge (T-Bridge) made out of monolithic zirconia bonded to a titanium base abutment (Variobase abutments)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 20 years

Willingness to sign an informed consent and participate in the study

Three missing adjacent teeth in the posterior site.

Tooth gap of 21-24 mm.

Disqualifiers

Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol

Any disorder that would interfere with wound healing or represent a contraindication for implant surgery, such as but not limited to uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates.

Pregnancy or lactation

Heavy smoking habit with ≥ 10 cig/d

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dual-cantilevered implant bridge

    Device

    A 3-unit supported by one implant in the middle

  • 3-unit iFDP

    Device

    3-unit fixed dental prosthesis supported by two implants

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: TestExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Implant and prosthetic success

Primary outcome parameter: implant and prosthetic success Implant success and survival rate will be defined according to established criteria (Buser et al. 1991): A surviving implant and/or restoration is defined as are in place at the time of the follow-up.

Time frame
10 years
2

Implant and prosthetic survival

Implant success and survival rate will be defined according to established criteria (Buser et al. 1991): A surviving implant and/or restoration is defined as are in place at the time of the follow-up.

Time frame
10 years

Secondary outcomes

1

Implant and prosthetic complications

Biological and/or Technical Implant and prosthetic complications

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bern

Lead sponsor

ITI International Team for Implantology, Switzerland

Collaborator