Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses

Study Overview
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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.

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

Conditions
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Final Loss of Restauration, Restauration in Situ, Debonded Restauration

Intervention / Treatment
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* Other: Multilink
* Other: Panavia 21 TC


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multilink<br>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<br>* 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)<br>* Other names: A/B-Primer, Ivoclar Vivadent;|
| Active Comparator: Panavia 21 TC<br>RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer | Other: Panavia 21 TC<br>* 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<br>* Other names: Panavia 21 TC, Kuraray;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final Loss of the Restauration |  | 5 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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All-Ceramic, Single Retainer, Resin-bonded Fixed Dental Protheses, Randomized Clinical Trial, Resin Bond, Bonding System