Clinical Performance of Dual-cantilevered Single-implant Bridge

Study Overview
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Brief Summary
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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)

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

Conditions
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Dental Implant Failed

Intervention / Treatment
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* Device: Dual-cantilevered implant bridge
* Device: 3-unit iFDP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Dual-cantilevered single implant bridge | Device: Dual-cantilevered implant bridge<br>* A 3-unit supported by one implant in the middle<br>|
| Active Comparator: Control<br>3-unit implant fixed dental prosthesis | Device: 3-unit iFDP<br>* 3-unit fixed dental prosthesis supported by two implants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant and prosthetic complications | Biological and/or Technical Implant and prosthetic complications | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implant