Clinical Performance of Dual-cantilevered Single-implant Bridge

NCT06099717 | Recruiting

• 1 other identifier: Dual-cantilever single-implant
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Dental Implant Failed

Keywords

Dental implant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Implant and prosthetic complications

  10 years

Study Arms (2)

Test

EXPERIMENTAL

Dual-cantilevered single implant bridge

Device: Dual-cantilevered implant bridge

Control

ACTIVE COMPARATOR

3-unit implant fixed dental prosthesis

Device: 3-unit iFDP

Interventions

Dual-cantilevered implant bridge DEVICE

A 3-unit supported by one implant in the middle

Test

3-unit iFDP DEVICE

3-unit fixed dental prosthesis supported by two implants

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead
• ITI International Team for Implantology, Switzerland: collaborator

Study Sites (1)

Universidade Federal de Goias

Goiânia, Goiás, 74605-220, Brazil

RECRUITING

Study Officials

• Martin Schimmel, Prof

  University of Bern

  STUDY CHAIR

Central Study Contacts

Manrique Fonseca, Dr

CONTACT

+416840630; manrique.fonseca@unibe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: June 30, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)