Partial Edentulism
Conditions
Brief summary
The objective of the study is to evaluate the clinical performance of Procera® Bridge Zirconia veneered with NobelRondo Zirconia.
Detailed description
The study was designed to be an open, 5-year, prospective, multi-center clinical post-market study. The objectives of this clinical study were that industrial centrally produced 3- or 4-unit bridges of yttrium-oxide partially-stabilized (Y-TZP) zirconia (Procera Zirconia) in combination with the veneering ceramic material NobelRondo will show sufficient CDA ratings (90% R+S) and a sufficient survival rate after 1 and 5 years.
Interventions
DEVICEProcera® Bridge Zirconia
Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Sponsors
Nobel Biocare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible * Indication: same indication as for metal supported bridges * Obtained informed consent from the patient
Exclusion criteria
* Currently known alcohol, drug or medication abuse, judged by the investigator, which might influence the follow-up program * Patients where a bridge part connection area of 3 mm of diameter is not possible to obtain (short clinical crowns) * Mobility of the abutment teeth exceeding grade I * Patients with pathologic pocket formation at abutment teeth * Patients with complete dentures in the opposing jaw * Patients with a removable partial denture in the same jaw
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Bridge Procera Bridge Zirconia | prosthesis delivery, 1 year | The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Bridge Procera Bridge Zirconia | prosthesis delivery, 5 years | The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Procera® Bridge Zirconia Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | Procera® Bridge Zirconia |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 38 / 80 |
| serious Total, serious adverse events | 3 / 80 |
Outcome results
Primary
Success Rate of Bridge Procera Bridge Zirconia
The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.
Time frame: prosthesis delivery, 1 year
Population: 78 patients were treated in total. 4 of the patients received two bridges (which is complaint with the protocol). Therefore there are more bridges than patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Procera® Bridge Zirconia | Success Rate of Bridge Procera Bridge Zirconia | 100 percentage of successful implants |
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
Success Rate of Bridge Procera Bridge Zirconia
The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.
Time frame: prosthesis delivery, 5 years
Population: 5 year data. Not all initially treated patients could be followed over the 5 years.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Procera® Bridge Zirconia | Success Rate of Bridge Procera Bridge Zirconia | 95.8 percentage of successful implants |