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The objective of this prospective clinical study is to investigate the differences in the complication rates between tooth- and implant- supported zirconia based fixed dental prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference in the complication rates between implant- supported and tooth- supported zirconia FDPs.
The study aims to provide evidence regarding the clinical behaviour of long-span tooth- and implant-supported FDPs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tooth-supported | Experimental | Long-span tooth-supported zirconia based fixed dental prostheses |
|
| Implant-supported | Active Comparator | Long-span implant-supported zirconia based fixed dental prostheses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teeth abutment | Device |
|
| |
| Implant abutments |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Fixed Dental Prostheses (FDPs) With Failure | "Failure" was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Fixed Dental Prostheses (FDPs) With Chip/s | Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of of Fixed Dental Prostheses (FDPs) With Rough Surface | Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations. | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25446240 | Derived | Konstantinidis IK, Jacoby S, Radel M, Boning K. Prospective evaluation of zirconia based tooth- and implant-supported fixed dental prostheses: 3-year results. J Dent. 2015 Jan;43(1):87-93. doi: 10.1016/j.jdent.2014.10.011. Epub 2014 Nov 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tooth-supported | Long-span tooth-supported zirconia based fixed dental prostheses Teeth abutment |
| FG001 | Implant-supported | Long-span implant-supported zirconia based fixed dental prostheses Implant abutments |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tooth-supported | Long-span tooth-supported zirconia based fixed dental prostheses Teeth abutment |
| BG001 | Implant-supported | Long-span implant-supported zirconia based fixed dental prostheses Implant abutments |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Fixed Dental Prostheses (FDPs) With Failure | "Failure" was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period. | Posted | Number | FDPs with failure | 3 years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tooth-supported | Long-span tooth-supported zirconia based fixed dental prostheses Teeth abutment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Konstantinidis Ioannis | Zahnärztliche Prothetik | +49 351 458 4231 | ioannis.konstantinidis@uniklinikum-dresden.de |
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| Device |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number of Fixed Dental Prostheses (FDPs) With Chip/s | Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported. | Posted | Number | FDPs with chip/s | 3 years |
|
|
|
|
| Other Pre-specified | Number of of Fixed Dental Prostheses (FDPs) With Rough Surface | Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations. | Posted | Number | FDPs with rough surface | 3 years |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Implant-supported | Long-span implant-supported zirconia based fixed dental prostheses Implant abutments | 0 | 8 | 0 | 8 |
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