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| Name | Class |
|---|---|
| Ivoclar Vivadent AG | INDUSTRY |
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The purpose of this prospective study was to evaluate the clinical outcome of all-ceramic RBFDP with a cantilevered single-retainer design made from zirconia ceramic. To evaluate the impact of the adhesive system used an established resin cement with an integrated adhesive monomer (Panavia 21 TC) and a resin cement with a separate primer (Multilink Automix with Metal/Zirconia Primer) were compared within the study on a randomized basis.
The aim of the present randomized study was to evaluate wether the difference in bond strength of Panavia and Multilink Automix with Metal/Zirconia Primer to densely sintered zirconia ceramic (IPS e.max ZirCAD, Ivoclar Vivadent) has any impact on the clinical outcome of all-ceramic RBFDP with a cantilevered single-retainer design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multilink | Active Comparator | RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer) |
|
| Panavia 21 TC | Active Comparator | RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multilink | Other | After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer) |
| Measure | Description | Time Frame |
|---|---|---|
| Final Loss of the Restauration | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Debonding of the RBFDP | Restoration was rebonded without any impairment of function | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Kern, DDS, PhD | University of Kiel | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23930573 | Derived | Sasse M, Kern M. CAD/CAM single retainer zirconia-ceramic resin-bonded fixed dental prostheses: clinical outcome after 5 years. Int J Comput Dent. 2013;16(2):109-18. English, German. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multilink | 14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer). Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer). Patients were recalled after 6 and 12 months, and then annually. |
| FG001 | Panavia 21 TC | 16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer. Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer. Patients were recalled after 6 and 12 months, and then annually. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Multilink | 14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer). Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer). Patients were recalled after 6 and 12 months, and then annually. |
| 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 | Final Loss of the Restauration | Posted | Number | participants | 5 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 | Multilink | 14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer). Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer). Patients were recalled after 6 and 12 months, and then annually. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Debonding | Investigations | Non-systematic Assessment | Debonding of RBFDP. Treatment: Rebonding as initially conducted. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martin Sasse, D.M.D., Assistant Professor | University of Kiel | +494315972874 | sekretariat@proth.uni-kiel.de |
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| ID | Term |
|---|---|
| C502351 | multilink adhesive system |
| D008670 | Metals |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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| Panavia 21 TC | Other | After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer |
|
|
| BG001 | Panavia 21 TC | 16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer. Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer. Patients were recalled after 6 and 12 months, and then annually. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.
Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.
Patients were recalled after 6 and 12 months, and then annually.
|
|
| Secondary | Debonding of the RBFDP | Restoration was rebonded without any impairment of function | Posted | Number | participants | 5 years |
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Panavia 21 TC | 16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer. Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer. Patients were recalled after 6 and 12 months, and then annually. | 0 | 16 | 1 | 16 |
|
| [Small Caries lesion] | Investigations | Non-systematic Assessment | Treatment: Composite resin filling. |
|
| [Rotation of abutment tooth] | Investigations | Non-systematic Assessment | Treatment: Derotated with a splint. |
|
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