Clinical Performance of Dual-cantilevered Single-implant Bridge

NCT ID: NCT06099717

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2026-10-31

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)

Detailed Description

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Conditions

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Dental Implant Failed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Group allocation

Study Groups

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Test

Dual-cantilevered single implant bridge

Group Type EXPERIMENTAL

Dual-cantilevered implant bridge

Intervention Type DEVICE

A 3-unit supported by one implant in the middle

Control

3-unit implant fixed dental prosthesis

Group Type ACTIVE_COMPARATOR

3-unit iFDP

Intervention Type DEVICE

3-unit fixed dental prosthesis supported by two implants

Interventions

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Dual-cantilevered implant bridge

A 3-unit supported by one implant in the middle

Intervention Type DEVICE

3-unit iFDP

3-unit fixed dental prosthesis supported by two implants

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ITI International Team for Implantology, Switzerland

OTHER

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Schimmel, Prof

Role: STUDY_CHAIR

University of Bern

Locations

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Universidade Federal de Goias

Goiânia, Goiás, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Manrique Fonseca, Dr

Role: CONTACT

+416840630

Facility Contacts

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Claudio Leles, Prof.

Role: primary

+5562 3209-6052

Other Identifiers

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Dual-cantilever single-implant

Identifier Type: -

Identifier Source: org_study_id

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