Clinical Performance of Dual-cantilevered Single-implant Bridge (T-bridge)

Clinical Performance of a Novel Implant-supported Fixed Dental Prostheses (iFDP): the Dual-cantilevered Single-implant Bridge (T-bridge)

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)

Study Overview

• Status: Recruiting
• Conditions: Dental Implant Failed
• Intervention / Treatment: Device: Dual-cantilevered implant bridge; Device: 3-unit iFDP

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manrique Fonseca, Dr; Phone Number: +416840630; Email: manrique.fonseca@unibe.ch

Study Locations

• Brazil
  • Goiás
    • Goiânia, Goiás, Brazil, 74605-220
      • Recruiting
      • Universidade Federal de Goias
      • Contact: Claudio Leles, Prof.; Phone Number: +5562 3209-6052; Email: claudio_leles@ufg.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.
• Presence of natural or artificial opposing dentition
• Sufficient vertical interocclusal space of an implant restoration (7mm)
• Sufficient ridge height to place an implant of 10mm in length
• Sufficient ridge width for the placement of a 4.1mm diameter implant. Simultaneous GBR to achieve a width of 6.5mm will be included.

Exclusion Criteria:

• 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
• Severe bruxism or clenching habits, presence of oro-facial pain
• Insufficient ridge width/height for the study implant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Dual-cantilevered single implant bridge	Device: Dual-cantilevered implant bridge; A 3-unit supported by one implant in the middle
Active Comparator: Control; 3-unit implant fixed dental prosthesis	Device: 3-unit iFDP; 3-unit fixed dental prosthesis supported by two implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years
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.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant and prosthetic complications	Biological and/or Technical Implant and prosthetic complications	10 years

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: ITI International Team for Implantology, Switzerland
• Investigators: Study Chair: Martin Schimmel, Prof, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Dental implant
• Other Study ID Numbers: Dual-cantilever single-implant

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No