Clinical Performance of a Novel Implant-supported Fixed Dental Prostheses (iFDP): the Dual-cantilevered Single-implant Bridge (T-bridge)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Bern
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Implant and prosthetic success
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
Group allocation
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Test
Dual-cantilevered single implant bridge
Intervention: Dual-cantilevered implant bridge (Device)
Control
3-unit implant fixed dental prosthesis
Intervention: 3-unit iFDP (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Implant and prosthetic complications(10 years)