Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses

September 4, 2014 updated by: Martin Sasse, University of Kiel

Randomized Clinical Trial on Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses: Impact of the Bonding System

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Panavia 21 TC, Kuraray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Final Loss of the Restauration
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Debonding of the RBFDP
Time Frame: 5 years
Restoration was rebonded without any impairment of function
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kiel

Collaborators

Ivoclar Vivadent AG

Investigators

  • Study Director: Matthias Kern, DDS, PhD, University of Kiel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

August 3, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (Estimate)

August 8, 2011

Study Record Updates

Last Update Posted (Estimate)

September 11, 2014

Last Update Submitted That Met QC Criteria

September 4, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Ivoclar ZirCAD Adh.bruecken

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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