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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

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.


Condition or disease Intervention/treatment Phase
Restauration in Situ Final Loss of Restauration Debonded Restauration Other: Multilink Other: Panavia 21 TC Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial on Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses: Impact of the Bonding System
Study Start Date : October 2006
Actual Primary Completion Date : April 2008
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
Active Comparator: Multilink
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)
Other: Multilink
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)
Other Names:
  • Multilink-Automix, Ivoclar Vivadent
  • Metal/Zirconia-Primer, Ivoclar Vivadent
  • A/B-Primer, Ivoclar Vivadent
Active Comparator: Panavia 21 TC
RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer
Other: 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
Other Name: Panavia 21 TC, Kuraray



Primary Outcome Measures :
  1. Final Loss of the Restauration [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Debonding of the RBFDP [ Time Frame: 5 years ]
    Restoration was rebonded without any impairment of function



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411592


Sponsors and Collaborators
University of Kiel
Ivoclar Vivadent AG
Investigators
Study Director: Matthias Kern, DDS, PhD University of Kiel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin Sasse, Dr. Martin Sasse, D.M.D., Assistant Professor, University of Kiel
ClinicalTrials.gov Identifier: NCT01411592     History of Changes
Other Study ID Numbers: Ivoclar ZirCAD Adh.bruecken
First Posted: August 8, 2011    Key Record Dates
Results First Posted: September 11, 2014
Last Update Posted: September 11, 2014
Last Verified: September 2014

Keywords provided by Martin Sasse, University of Kiel:
All-Ceramic
Resin-bonded Fixed Dental Protheses
Single Retainer
Randomized Clinical Trial
Resin Bond
Bonding System