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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University of BernThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a Novel Implant-supported Fixed Dental Prostheses (iFDP): the Dual-cantilevered Single-implant Bridge (T-bridge)
- ClinicalTrials.gov ID
- NCT06099717
- Acronym / sponsor ID
- T-bridge / Dual-cantilever single-implant
- Conditions
- Dental Implant Failed
- Keywords
- Dental implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Device: Dual-cantilevered implant bridgeDual-cantilevered single implant bridge |
| Control | Active comparator | Device: 3-unit iFDP3-unit implant fixed dental prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-cantilevered implant bridgeA 3-unit supported by one implant in the middle | Device | Test |
| 3-unit iFDP3-unit fixed dental prosthesis supported by two implants | Device | Control |
Primary outcome
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.
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.
1 secondary outcome
Implant and prosthetic complications
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Schimmel, Prof study chair
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manrique Fonseca, Dr (+416840630, manrique.fonseca@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant and prosthetic success (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.