Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Kiel.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ivoclar Vivadent AG
Information provided by (Responsible Party):
Martin Sasse, University of Kiel
ClinicalTrials.gov Identifier:
NCT01411592
First received: August 3, 2011
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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 Intervention
Restauration in Situ
Final Loss of Restauration
Debonded Restauration
Other: Multilink bonding
Other: Panavia 21 TC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Kiel:

Primary Outcome Measures:
  • Final loss of the restauration [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Debonding of the RBFDP [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2006
Estimated Study Completion Date: April 2013
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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)
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

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411592

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

No publications provided by University of Kiel

Additional 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
Study First Received: August 3, 2011
Last Updated: November 22, 2011
Health Authority: Germany: Ministry of health and occupational safety in Schleswig-Holstein

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

ClinicalTrials.gov processed this record on August 18, 2014