An interventional study of High-translucent monolithic zirconia Bridge and Zirconium oxide ceramics Framework in Dental Prosthesis Failure, sponsored by Branemarkkliniken. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-03-25.
Sponsored by Branemarkkliniken · Not applicable, Interventional, and Treatment
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
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
119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.
This study's planned enrollment of 60 is above the median of 36 across 69 interventional studies indexed under Prosthesis Failure.
Browse Prosthesis Failure studies →Branemarkkliniken is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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edentulous behind the canine in the maxilla or mandible
Exclusion Criteria:
Device: High-translucent monolithic zirconia Bridge
Device: Zirconium oxide ceramics Framework
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).
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).
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).
Complication rate
Time frame: From placement of prosthetic Bridge until last follow-up of the study after 5 years
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2020 (actual). Primary completion is estimated for Dec 2028, 99 months after the start.
Of 48 non-industry interventional studies with no phase under Prosthesis Failure, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 99 months is above that.
Counting every sponsor, half of 50 studies reached it within 18 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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