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NCT Number: NCT06099717

Clinical Performance of Dual-cantilevered Single-implant 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)

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Goias

Goiânia, Goiás, 74605-220, Brazil

Location status: Recruiting

Location contact

Claudio Leles, Prof.

CONTACT

[email protected]

+5562 3209-6052

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Implant and prosthetic success

    Time frame: 10 years

    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.

  2. Implant and prosthetic survival

    Time frame: 10 years

    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.

Secondary outcomes

  1. Implant and prosthetic complications

    Time frame: 10 years

    Biological and/or Technical Implant and prosthetic complications

Study contacts

Contact information is provided by the study sponsor or research team.

Manrique Fonseca, Dr

CONTACT

[email protected]

+416840630

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • ITI International Team for Implantology, Switzerland

Registry information

Official study title

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

Acronym: T-bridge

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 25, 2023
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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