Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352983
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2024-03-20
Brief Title:
Zirconium Dioxide Fixed Dental Prosthesis
Sponsor:
Malmö University
Organization:
Malmö University
Study Overview
Official Title:
Monolithic- and Partially Veneered High-translucent Zirconium Dioxide YSZ a 4-year Follow-up of a Multicenter Prospective Randomized Controlled Trial on Posterior FDPs
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to evaluate and compare bridges to replace one or two missing teeth in the mouth The bridges will be made of two variants of ceramic material We will evaluate the bridges for up to five years regarding technical and biological complications
Detailed Description:
Purpose
The purpose of this prospective randomized double blinded clinical trial is to systematically evaluate and compare the long-term durability of monolithic zirconium dioxide and veneered zirconium dioxide based 3- 4- or 5-unit bridges in the posterior dentition over time The durability will be evaluated by recording technical and biological complications
Background
Fixed dental prosthesis FDP therapy is a common therapy Usually the FDPs are made by combining a metal frame with a veneer to give the body a more tooth-like appearance known as porcelain-fused-to-metal
For 20 years we have used ceramic frames as an alternative to metal since it has better biological and aesthetic properties A common complication with these newer materials however is that the porcelain veneer debonds from the substructure which sometimes leads to a need for remaking the FDP
Zirconium dioxide or yttria stabilized tetragonal polycrystalline zirconium dioxide Y-TZP is an oxide ceramic with excellent characteristics such as high strength and biocompatibility We currently use this ceramic routinely in dentistry for the production of both crowns and FDPs It is now a well-documented and reliable material
The monolithic restorations that is Y-TZP without veneer have been developed over the past few years The former core materials in Y-TZP were opaque white-colored but have recently undergone development to become much more esthetic by increased translucency and improving staining techniques without losing strength By using only the strong oxide ceramic throughout we can obtain strong materials that have good biological properties but without the risk of porcelain veneering fractures
Laboratory studies evaluating crown therapy have shown very good results regarding these monolithic materials but clinical trials on FDPs are missing The long-term clinical studies on FDPs available concern veneered Y-TZP which have achieved acceptable results with good survival rate but with some complications in the form of veneer fractures The veneering technique and materials for Y-TZP FDPs have since been developed to decrease the risk of chip-off fractures and recent publications show promising results The aim of this study is therefore to compare survival and complications rates of Y-TZP FDPs with veneer and without veneer monolithic respectively
Question
The null hypothesis for this study is that monolithic Y-TZP based FDPs will perform equivalent to the veneered Y-TZP based FDPs when used for constructions in the posterior dentition
Study population
Patients for the study will be recruited within the daily dental care operations at clinics in Public and Private Dental Services
Study method and randomization
Included patients will undergo treatment in the form of preparation of the teeth and an impression taken for FDP therapy The dentist does not know which of the two different FDP materials his patient will receive The dental laboratory will receive a requisition from the dentist with a code number This code number is randomized to one of the two materials to be investigated Half of the patients will get a veneered zirconia based FDP while the other half receives a monolithic zirconia based The finished FDP will then be cemented in the same way regardless of material Method of treatment FDP materials and cementation is performed according to a standardized protocol used routinely in dentistry
Evaluation methods
The evaluation is done by recording technical and biological complications The examination is conducted by intraoral inspection and photo documentation and is performed by dentists not involved in the performed treatments
Quality control and reporting
Will be published in a scientific journal
The purpose of this prospective randomized double blinded clinical trial is to systematically evaluate and compare the long-term durability of monolithic zirconium dioxide and veneered zirconium dioxide based 3- 4- or 5-unit bridges in the posterior dentition over time The durability will be evaluated by recording technical and biological complications
Background
Fixed dental prosthesis FDP therapy is a common therapy Usually the FDPs are made by combining a metal frame with a veneer to give the body a more tooth-like appearance known as porcelain-fused-to-metal
For 20 years we have used ceramic frames as an alternative to metal since it has better biological and aesthetic properties A common complication with these newer materials however is that the porcelain veneer debonds from the substructure which sometimes leads to a need for remaking the FDP
Zirconium dioxide or yttria stabilized tetragonal polycrystalline zirconium dioxide Y-TZP is an oxide ceramic with excellent characteristics such as high strength and biocompatibility We currently use this ceramic routinely in dentistry for the production of both crowns and FDPs It is now a well-documented and reliable material
The monolithic restorations that is Y-TZP without veneer have been developed over the past few years The former core materials in Y-TZP were opaque white-colored but have recently undergone development to become much more esthetic by increased translucency and improving staining techniques without losing strength By using only the strong oxide ceramic throughout we can obtain strong materials that have good biological properties but without the risk of porcelain veneering fractures
Laboratory studies evaluating crown therapy have shown very good results regarding these monolithic materials but clinical trials on FDPs are missing The long-term clinical studies on FDPs available concern veneered Y-TZP which have achieved acceptable results with good survival rate but with some complications in the form of veneer fractures The veneering technique and materials for Y-TZP FDPs have since been developed to decrease the risk of chip-off fractures and recent publications show promising results The aim of this study is therefore to compare survival and complications rates of Y-TZP FDPs with veneer and without veneer monolithic respectively
Question
The null hypothesis for this study is that monolithic Y-TZP based FDPs will perform equivalent to the veneered Y-TZP based FDPs when used for constructions in the posterior dentition
Study population
Patients for the study will be recruited within the daily dental care operations at clinics in Public and Private Dental Services
Study method and randomization
Included patients will undergo treatment in the form of preparation of the teeth and an impression taken for FDP therapy The dentist does not know which of the two different FDP materials his patient will receive The dental laboratory will receive a requisition from the dentist with a code number This code number is randomized to one of the two materials to be investigated Half of the patients will get a veneered zirconia based FDP while the other half receives a monolithic zirconia based The finished FDP will then be cemented in the same way regardless of material Method of treatment FDP materials and cementation is performed according to a standardized protocol used routinely in dentistry
Evaluation methods
The evaluation is done by recording technical and biological complications The examination is conducted by intraoral inspection and photo documentation and is performed by dentists not involved in the performed treatments
Quality control and reporting
Will be published in a scientific journal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None