Zirconia Based Fixed Dental Prostheses
Conditions
Keywords
prospective study, chipping, survival rate, fracture resistance, zirconia
Brief summary
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.
Detailed description
The study aims to provide evidence regarding the clinical behaviour of long-span tooth- and implant-supported FDPs.
Interventions
DEVICETeeth abutment
DEVICEImplant abutments
Sponsors
Technische Universität Dresden
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients older than 18 years * Missing of at least two adjacent teeth in the maxilla or mandibular * Sufficient oral hygiene
Exclusion criteria
* Addiction to alcohol or drugs * Severe craniomandibular disorders * Severe systematic diseases * Patients unable or unwilling to sign the informed consent form * Untreated periodontitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Fixed Dental Prostheses (FDPs) With Failure | 3 years | Failure was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Fixed Dental Prostheses (FDPs) With Chip/s | 3 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of of Fixed Dental Prostheses (FDPs) With Rough Surface | 3 years | Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tooth-supported Long-span tooth-supported zirconia based fixed dental prostheses
Teeth abutment | 24 |
| Implant-supported Long-span implant-supported zirconia based fixed dental prostheses
Implant abutments | 8 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | Tooth-supported | Implant-supported | Total |
|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 9.01 | 53.9 years STANDARD_DEVIATION 10.9 | 54.9 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 11 Participants | 4 Participants | 15 Participants |
| Sex: Female, Male Male | 13 Participants | 4 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 8 |
| serious Total, serious adverse events | 0 / 24 | 0 / 8 |
Outcome results
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.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tooth-supported | Number of Fixed Dental Prostheses (FDPs) With Failure | 0 FDPs with failure |
| Implant-supported | Number of Fixed Dental Prostheses (FDPs) With Failure | 1 FDPs with failure |
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.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tooth-supported | Number of Fixed Dental Prostheses (FDPs) With Chip/s | 3 FDPs with chip/s |
| Implant-supported | Number of Fixed Dental Prostheses (FDPs) With Chip/s | 5 FDPs with chip/s |
Comparison: Null hypothesis: The chipping rates between tooth- and implant- supoorted FDPs are equally distributed.p-value: 0.03Log Rank
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.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tooth-supported | Number of of Fixed Dental Prostheses (FDPs) With Rough Surface | 13 FDPs with rough surface |
| Implant-supported | Number of of Fixed Dental Prostheses (FDPs) With Rough Surface | 7 FDPs with rough surface |