Clinical Performance of Dual-cantilevered Single-implant Bridge
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dual-cantilevered implant bridge, 3-unit iFDP.
- Who it may be relevant to
- Registry conditions: Dental Implant Failed. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Performance of a Novel Implant-supported Fixed Dental Prostheses (iFDP): the Dual-cantilevered Single-implant Bridge (T-bridge)
Overview
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)
Interventions
- Device Dual-cantilevered implant bridge
A 3-unit supported by one implant in the middle - Device 3-unit iFDP
3-unit fixed dental prosthesis supported by two implants
Primary outcome measures
- Implant and prosthetic success [Time frame: 10 years]
- Implant and prosthetic survival [Time frame: 10 years]
Secondary outcome measures (1)
- Implant and prosthetic complications [Time frame: 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Universidade Federal de Goias — Goiânia
Identifiers
NCT: NCT06099717 · Dual-cantilever single-implant