Clinical Performance of Dual-cantilevered Single-implant Bridge

Not Applicable

Recruiting

• Conditions: Dental Implant Failed
• Interventions: Device: Dual-cantilevered implant bridge; Device: 3-unit iFDP

• Registration Number: NCT06099717
• Lead Sponsor: University of Bern

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-25
• Study Start: 2024-06-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-18
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Dual-cantilevered implant bridge	Dual-cantilevered single implant bridge
Control	3-unit iFDP	3-unit implant fixed dental prosthesis

Primary Outcome Measures

Name	Time	Method
Implant and prosthetic success	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	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 Outcome Measures

Name	Time	Method
Implant and prosthetic complications	10 years	Biological and/or Technical Implant and prosthetic complications

Trial Locations

Locations (1)

Universidade Federal de Goias; 🇧🇷 Goiania, Goias, Brazil