Debonded Restauration, Final Loss of Restauration, Restauration in Situ
Conditions
Keywords
All-Ceramic, Resin-bonded Fixed Dental Protheses, Single Retainer, Randomized Clinical Trial, Resin Bond, Bonding System
Brief summary
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.
Interventions
OTHERMultilink
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)
OTHERPanavia 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
Sponsors
Ivoclar Vivadent AG
University of Kiel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* sufficient oral hygiene * one caries free or almost caries free abutment tooth available * sufficient space for the retainer wing available * patients willingness to return at regular intervals for at least 5 years for evaluation
Exclusion criteria
* clinical symptoms of bruxism * collision, full or semi-contact sports (Boxing, Karate) * pregnant women * untreated advanced periodontitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Final Loss of the Restauration | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Debonding of the RBFDP | 5 years | Restoration was rebonded without any impairment of function |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 16 |
| Total | 30 |
Baseline characteristics
| Characteristic | Multilink | Panavia 21 TC | Total |
|---|---|---|---|
| Age, Continuous | 29.57 years STANDARD_DEVIATION 16.84 | 36.56 years STANDARD_DEVIATION 20.36 | 33.3 years STANDARD_DEVIATION 18.82 |
| Region of Enrollment Germany | 14 participants | 16 participants | 30 participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 14 | 1 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 16 |
Outcome results
Primary
Final Loss of the Restauration
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Multilink | Final Loss of the Restauration | 0 participants |
| Panavia 21 TC | Final Loss of the Restauration | 0 participants |
Secondary
Debonding of the RBFDP
Restoration was rebonded without any impairment of function
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Multilink | Debonding of the RBFDP | 1 participants |
| Panavia 21 TC | Debonding of the RBFDP | 1 participants |