Clinical Performance of Dual-cantilevered Single-implant Bridge (T-bridge)

University of Bern

Status: Not yet enrolling

Conditions: Dental Implant Failed

Treatments: Device: 3-unit iFDP; Device: Dual-cantilevered implant bridge

Study type: Interventional

Funder types: Other

Identifiers

NCT06099717

Dual-cantilever single-implant

Details and patient eligibility

About

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)

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Test

Experimental group

Description:

Dual-cantilevered single implant bridge

Treatment:

Device: Dual-cantilevered implant bridge

Control

Active Comparator group

Description:

3-unit implant fixed dental prosthesis

Treatment:

Device: 3-unit iFDP