Trial Outcomes & Findings for Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses (NCT NCT01411592)
NCT ID: NCT01411592
Last Updated: 2014-09-11
Results Overview
Recruitment status
UNKNOWN
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
5 years
Results posted on
2014-09-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
5-Year Time Frame
|
14
|
16
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses
Baseline characteristics by cohort
| Measure |
Multilink
n=14 Participants
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.
|
Panavia 21 TC
n=16 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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.57 years
STANDARD_DEVIATION 16.84 • n=5 Participants
|
36.56 years
STANDARD_DEVIATION 20.36 • n=7 Participants
|
33.3 years
STANDARD_DEVIATION 18.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
Multilink
n=14 Participants
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.
|
Panavia 21 TC
n=16 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.
|
|---|---|---|
|
Final Loss of the Restauration
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 5 yearsRestoration was rebonded without any impairment of function
Outcome measures
| Measure |
Multilink
n=14 Participants
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.
|
Panavia 21 TC
n=16 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.
|
|---|---|---|
|
Debonding of the RBFDP
|
1 participants
|
1 participants
|
Adverse Events
Multilink
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Panavia 21 TC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Multilink
n=14 participants at risk
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.
|
Panavia 21 TC
n=16 participants at risk
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.
|
|---|---|---|
|
Investigations
Debonding
|
7.1%
1/14 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Investigations
[Small Caries lesion]
|
0.00%
0/14
|
6.2%
1/16 • Number of events 1
|
|
Investigations
[Rotation of abutment tooth]
|
0.00%
0/14
|
6.2%
1/16 • Number of events 1
|
Additional Information
Dr. Martin Sasse, D.M.D., Assistant Professor
University of Kiel
Phone: +494315972874
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place