Overview

This trial is active, not recruiting.

Conditions restauration in situ, final loss of restauration, debonded restauration
Treatments multilink bonding, panavia 21 tc
Sponsor University of Kiel
Collaborator Ivoclar Vivadent AG
Start date October 2006
End date April 2008
Trial size 30 participants
Trial identifier NCT01411592, Ivoclar ZirCAD Adh.bruecken

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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 Multilink-Automix, Ivoclar Vivadent
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)
(Active Comparator)
RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer
panavia 21 tc Panavia 21 TC, Kuraray
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

Primary Outcomes

Measure
Final loss of the restauration
time frame: 5 years

Secondary Outcomes

Measure
Debonding of the RBFDP
time frame: 5 years

Eligibility Criteria

Male or female participants at least 14 years old.

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

Additional Information

Official title Randomized Clinical Trial on Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses: Impact of the Bonding System
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by University of Kiel.