Dental Implant FailedT-bridgeNCT06099717
Clinical Performance of Dual-cantilevered Single-implant Bridge
A study testing Dual-cantilevered implant bridge and 3-unit iFDP in people with Dental Implant Failed, run by University of Bern at 1 site in Brazil.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- Dual-cantilevered implant bridge and 3-unit iFDP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jun 2024to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Goias
Goiânia, Goiás, 74605-220
Claudio Leles, Prof., +5562 3209-6052, claudio_leles@ufg.br
About this study
Official title: 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)
- Conditions
- Dental Implant Failed
- Being tested
- Dual-cantilevered implant bridge, 3-unit iFDP
- Keywords
- Dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-cantilevered implant bridgeDevice
A 3-unit supported by one implant in the middle
3-unit iFDPDevice
3-unit fixed dental prosthesis supported by two implants
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Dual-cantilevered single implant bridge Receives: Device: Dual-cantilevered implant bridge |
| Control | Active comparator | 3-unit implant fixed dental prosthesis Receives: Device: 3-unit iFDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 years
Secondary outcomes (1)
Implant and prosthetic complications
Biological and/or Technical Implant and prosthetic complications
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start30 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Responsible party
- Sponsor
- Investigators
- Martin Schimmel, Prof, Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099717
- Sponsor's protocol ID
- Dual-cantilever single-implant
- Acronym
- T-bridge
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No