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Recruiting NCT05296291

RCT: Titanium vs FCZ vs Zirconia Framework

No phase Interventional Dental Prosthesis Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-translucent monolithic zirconia Bridge, Zirconium oxide ceramics Framework, Metal-ceramic Framework.
Who it may be relevant to
Registry conditions: Dental Prosthesis Failure. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

RCT Study of Posterior Implant Supported Bridges Made of Various Prosthetic Materials

Overview

In recent years, zirconia-based implant-supported bridge designs have begun to be used more and more as an alternative to metal ceramic bridges. Another new material that has been introduced in the clinic is the high translucent monolithic zirconia, which has only been investigated a few follow-up studies with short follow up duration. The aim being to evaluate the clinical outcome of implant-anchored posterior bridges, made from 1. high-translucent monolithic zirconia, 2. zirconia ceramic with porcelain and 3. metal ceramics. The hypothesis is that high-translucent monolithic zirconia has lower rate of complications since surface porcelain veneering is not required. A total of 60 research subjects will be included in the study. Patients in need of a permanent implant-supported bridge, located posterior of the canine in the upper or lower jaw will be asked for participation. Each subject will be treated according to standard treatment protocols with implants from Nobel Biocare, the Branemark implant system and then be randomly assigned to obtain one of the following three type of bridges. 20 research subjects will be included in each of the three study arms. The prosthetic treatment will be carried out according to standard clinic protocol. All research subjects will be evaluated after 1, 3, 5 years. X-rays and photos will be taken at the installation of the bridges and after 1 and 5 years of follow-up or more frequent, depending on individual indication of the patient and the associated standard clinical care protocol. Personal data, implant survival, marginal bone loss and biological and technical complications related to the implants will be recorded. Survival of the bridge, technical and biological complication related to the bridge will also be recorded

Interventions

  • Device High-translucent monolithic zirconia Bridge
    Each patient will be treated according to standard of care with implants from Nobel Biocare, the Branmark system and then randomly assigned to receive a bridge made of either 1) metal ceramic (Nobel Procera, titanium skeleton), 2) zirconia ceramics (Nobel Procera zirconia skeleton) or 3) high-translucent monolithic zirconia (Nobel Procera).
  • Device Zirconium oxide ceramics Framework
    Each patient will be treated according to standard of care with implants from Nobel Biocare, the Branmark system and then randomly assigned to receive a bridge made of either 1) metal ceramic (Nobel Procera, titanium skeleton), 2) zirconia ceramics (Nobel Procera zirconia skeleton) or 3) high-translucent monolithic zirconia (Nobel Procera).
  • Device Metal-ceramic Framework
    Each patient will be treated according to standard of care with implants from Nobel Biocare, the Branmark system and then randomly assigned to receive a bridge made of either 1) metal ceramic (Nobel Procera, titanium skeleton), 2) zirconia ceramics (Nobel Procera zirconia skeleton) or 3) high-translucent monolithic zirconia (Nobel Procera).

Primary outcome measures

  • Complication rate [Time frame: From placement of prosthetic Bridge until last follow-up of the study after 5 years]

Eligibility criteria

Inclusion criteria

edentulous behind the canine in the maxilla or mandible

  • older than 18 years

Exclusion criteria

  • younger than 18 years
  • active periodontitis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • B R Å N E M A R K C L I N I C — Gothenburg

Publications

  • Kowar J, Turri A, Stenport V, Stervik C, Barkarmo S. Comparison of Materials in Implant-Supported Partial Fixed Dental Prostheses: A Randomized Controlled Trial. Clin Implant Dent Relat Res. 2026 Feb;28(1):e70129. doi: 10.1111/cid.70129. PMID 41672962

Identifiers

NCT: NCT05296291 · 2018-1563

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗