RCT: Titanium vs FCZ vs Zirconia Framework

Branemarkkliniken

Status: Enrolling

Conditions: Dental Prosthesis Failure

Treatments: Device: Zirconium oxide ceramics Framework; Device: High-translucent monolithic zirconia Bridge; Device: Metal-ceramic Framework

Study type: Interventional

Funder types: Other

Identifiers

NCT05296291

2018-1563

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

edentulous behind the canine in the maxilla or mandible

• older than 18 years

Exclusion criteria

• younger than 18 years
• active periodontitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

High-translucent monolithic zirconia,

Active Comparator group

Treatment:

Device: High-translucent monolithic zirconia Bridge

Zirconia ceramic with porcelain

Active Comparator group

Treatment:

Device: Zirconium oxide ceramics Framework

Metal ceramics.

Active Comparator group

Treatment:

Device: Metal-ceramic Framework