RCT: Titanium vs FCZ vs Zirconia Framework
Primary Purpose
Dental Prosthesis Failure
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
High-translucent monolithic zirconia Bridge
Zirconium oxide ceramics Framework
Metal-ceramic Framework
Sponsored by
About this trial
This is an interventional treatment trial for Dental Prosthesis Failure
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
Sites / Locations
- B R Å N E M A R K C L I N I CRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
High-translucent monolithic zirconia,
Zirconia ceramic with porcelain
Metal ceramics.
Arm Description
Outcomes
Primary Outcome Measures
Complication rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05296291
Brief Title
RCT: Titanium vs FCZ vs Zirconia Framework
Official Title
RCT Study of Posterior Implant Supported Bridges Made of Various Prosthetic Materials
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Branemarkkliniken
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
high-translucent monolithic zirconia,
zirconia ceramic with porcelain and
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Prosthesis Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-translucent monolithic zirconia,
Arm Type
Active Comparator
Arm Title
Zirconia ceramic with porcelain
Arm Type
Active Comparator
Arm Title
Metal ceramics.
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
High-translucent monolithic zirconia Bridge
Intervention Description
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
Intervention Name(s)
Zirconium oxide ceramics Framework
Intervention Description
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
Intervention Name(s)
Metal-ceramic Framework
Intervention Description
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 Measure Information:
Title
Complication rate
Time Frame
From placement of prosthetic Bridge until last follow-up of the study after 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Kowar
Phone
+46 700 206817
Email
jan.kowar@vgregion.se
Facility Information:
Facility Name
B R Å N E M A R K C L I N I C
City
Göteborg
ZIP/Postal Code
402 33
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Kowar
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RCT: Titanium vs FCZ vs Zirconia Framework
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