RCT: Titanium vs FCZ vs Zirconia Framework

Dental Prosthesis Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05296291
• Other study ID #: 2018-1563
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2022
• Source: Branemarkkliniken
• Contact: Jan Kowar
• Phone: +46 700 206817
• Email: jan.kowar[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

edentulous behind the canine in the maxilla or mandible

• older than 18 years

Exclusion Criteria:

• younger than 18 years

• active periodontitis

Related Conditions & MeSH terms

• Dental Prosthesis Failure
• Prosthesis Failure

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
Sweden	B R Å N E M A R K C L I N I C	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Branemarkkliniken

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate		From placement of prosthetic Bridge until last follow-up of the study after 5 years