Clinical Performance of Dual-cantilevered Single-implant Bridge

Dental Implant Failed Clinical Trial

— T-bridge  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06099717
• Other study ID #: Dual-cantilever single-implant
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: October 2026

Study information

• Verified date: November 2023
• Source: University of Bern
• Contact: Manrique Fonseca, Dr
• Phone: +416840630
• Email: manrique.fonseca[@]unibe.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant Failed

Intervention

Device:
• Dual-cantilevered implant bridge
A 3-unit supported by one implant in the middle
• 3-unit iFDP
3-unit fixed dental prosthesis supported by two implants

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	ITI International Team for Implantology, Switzerland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Implant and prosthetic complications	Biological and/or Technical Implant and prosthetic complications	10 years