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Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses

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ClinicalTrials.gov Identifier: NCT01411592
Recruitment Status : Unknown
Verified September 2014 by Martin Sasse, University of Kiel.
Recruitment status was:  Active, not recruiting
First Posted : August 8, 2011
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Sponsor:
Collaborator:
Ivoclar Vivadent AG
Information provided by (Responsible Party):
Martin Sasse, University of Kiel

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Restauration in Situ
Final Loss of Restauration
Debonded Restauration
Interventions Other: Multilink
Other: Panavia 21 TC
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Multilink Panavia 21 TC
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 14 16
5-Year Time Frame 14 16
Completed 14 16
Not Completed 0 0
Arm/Group Title Multilink Panavia 21 TC Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 14 16 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 16 participants 30 participants
29.57  (16.84) 36.56  (20.36) 33.3  (18.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
Female
12
  85.7%
10
  62.5%
22
  73.3%
Male
2
  14.3%
6
  37.5%
8
  26.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 14 participants 16 participants 30 participants
14 16 30
1.Primary Outcome
Title Final Loss of the Restauration
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Multilink Panavia 21 TC
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 14 16
Measure Type: Number
Unit of Measure: participants
0 0
2.Secondary Outcome
Title Debonding of the RBFDP
Hide Description Restoration was rebonded without any impairment of function
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Multilink Panavia 21 TC
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 14 16
Measure Type: Number
Unit of Measure: participants
1 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Multilink Panavia 21 TC
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Multilink Panavia 21 TC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Multilink Panavia 21 TC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Multilink Panavia 21 TC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      1/16 (6.25%)    
Investigations     
Debonding * [1]  1/14 (7.14%)  1 1/16 (6.25%)  1
[Small Caries lesion] * [2]  0/14 (0.00%)  0 1/16 (6.25%)  1
[Rotation of abutment tooth] * [3]  0/14 (0.00%)  0 1/16 (6.25%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Debonding of RBFDP. Treatment: Rebonding as initially conducted.
[2]
Treatment: Composite resin filling.
[3]
Treatment: Derotated with a splint.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Martin Sasse, D.M.D., Assistant Professor
Organization: University of Kiel
Phone: +494315972874
Responsible Party: Martin Sasse, University of Kiel
ClinicalTrials.gov Identifier: NCT01411592     History of Changes
Other Study ID Numbers: Ivoclar ZirCAD Adh.bruecken
First Submitted: August 3, 2011
First Posted: August 8, 2011
Results First Submitted: September 4, 2014
Results First Posted: September 11, 2014
Last Update Posted: September 11, 2014