RCT: Titanium vs FCZ vs Zirconia Framework

NCT ID: NCT05296291

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2028-12-31

Brief 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

Conditions

Dental Prosthesis Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High-translucent monolithic zirconia,

Group Type: ACTIVE_COMPARATOR

High-translucent monolithic zirconia Bridge

Intervention Type: DEVICE

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).

Zirconia ceramic with porcelain

Group Type: ACTIVE_COMPARATOR

Zirconium oxide ceramics Framework

Intervention Type: DEVICE

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 ceramics.

Group Type: ACTIVE_COMPARATOR

Metal-ceramic Framework

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Branemarkkliniken

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

B R Å N E M A R K C L I N I C

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Jan Kowar

Role: CONTACT

jan.kowar@vgregion.se

+46 700 206817

Facility Contacts

Jan Kowar

Role: primary

Other Identifiers

2018-1563

Identifier Type: -

Identifier Source: org_study_id