RCT: Titanium vs FCZ vs Zirconia Framework

NCT05296291 | Recruiting

• 1 other identifier: 2018-1563
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.high-translucent monolithic zirconia,
2. 2.zirconia ceramic with porcelain and
3. 3.metal ceramics. The hypothesis is that high-translucent monolithic zirconia has lower rate of complications since surface porcelain veneering is not required.

Conditions

Dental Prosthesis Failure

Outcome Measures

Primary Outcomes (1)

• Complication rate

  From placement of prosthetic Bridge until last follow-up of the study after 5 years

Study Arms (3)

High-translucent monolithic zirconia,

ACTIVE COMPARATOR

Device: High-translucent monolithic zirconia Bridge

Zirconia ceramic with porcelain

ACTIVE COMPARATOR

Device: Zirconium oxide ceramics Framework

Metal ceramics.

ACTIVE COMPARATOR

Device: Metal-ceramic Framework

Interventions

High-translucent monolithic zirconia Bridge 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).

High-translucent monolithic zirconia,

Zirconium oxide ceramics Framework 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

Metal-ceramic Framework 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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• edentulous behind the canine in the maxilla or mandible
• older than 18 years

You may not qualify if:

• younger than 18 years
• active periodontitis

Sponsors & Collaborators

• Branemarkkliniken: lead

Study Sites (1)

B R Å N E M A R K C L I N I C

Gothenburg, 402 33, Sweden

RECRUITING

Central Study Contacts

Jan Kowar

CONTACT

+46 700 206817; jan.kowar@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 25, 2022
• Study Start: September 1, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)