Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses

Not Applicable

• Conditions: Final Loss of Restauration; Restauration in Situ; Debonded Restauration
• Interventions: Other: Panavia 21 TC; Other: Multilink

• Registration Number: NCT01411592
• Lead Sponsor: University of Kiel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2008-04
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Status Verified: 2014-09
• Results First Submitted: 2014-09-04
• Results First Submitted QC: 2014-09-04
• Last Update Submitted: 2014-09-04
• Results First Posted: 2014-09-11
• Last Update Posted: 2014-09-11
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Final Loss of the Restauration	5 years

Secondary Outcome Measures

Name	Time	Method
Debonding of the RBFDP	5 years	Restoration was rebonded without any impairment of function