Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses

NCT ID: NCT01411592

Last Updated: 2014-09-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Restauration in Situ Final Loss of Restauration Debonded Restauration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Multilink

Intervention Type OTHER

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)

Panavia 21 TC

RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer

Group Type ACTIVE_COMPARATOR

Panavia 21 TC

Intervention Type OTHER

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

Interventions

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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)

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Multilink-Automix, Ivoclar Vivadent Metal/Zirconia-Primer, Ivoclar Vivadent A/B-Primer, Ivoclar Vivadent Panavia 21 TC, Kuraray

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ivoclar Vivadent AG

INDUSTRY

Sponsor Role collaborator

University of Kiel

OTHER

Sponsor Role lead

Responsible Party

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Martin Sasse

Dr. Martin Sasse, D.M.D., Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Kern, DDS, PhD

Role: STUDY_DIRECTOR

University of Kiel

References

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Sasse M, Kern M. CAD/CAM single retainer zirconia-ceramic resin-bonded fixed dental prostheses: clinical outcome after 5 years. Int J Comput Dent. 2013;16(2):109-18. English, German.

Reference Type DERIVED
PMID: 23930573 (View on PubMed)

Other Identifiers

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Ivoclar ZirCAD Adh.bruecken

Identifier Type: -

Identifier Source: org_study_id

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