Ceramic Tooth Restorations - a Comparison Study

Success and Survival of e.Max and KHF2 Etched Zirconia Cemented With Resin Cement - a Randomized Controlled Clinical Study

This randomized clinical study aims to compare success and survival of two different ceramic tooth restoration materials. The hypothesis for the study is that fluoride treated zirconia will retain as good as lithium disilicate reinforced glass ceramic when cemented by the same resin cement.

One group of patients will receive a restoration in fluoride treated zirconia, the other group will receive a restoration in reinforced glass ceramic. All restorations will be cemented in the same manner. At 3, 6, 12 and 24 months the participants will be examined.

Study Overview

• Status: Unknown
• Conditions: Dental Restoration Failure of Marginal Integrity
• Intervention / Treatment: Other: Ceramic tooth restoration

Detailed Description

A randomized controlled clinical study that aims to compare success and survival of potassium hydrogen difluoride (KHF2) etched zirconium dioxide and lithium disilicate reinforced glass ceramic cemented to molars/premolares using dual cure resin cement.

The null hypothesis for the study is that zirconium dioxide and lithium disilicate reinforced glass ceramic will retain equally good tooth substance when cemented with resin cement.

Participants are recruited from the student clinic at Faculty of Dentistry, University of Oslo. Patients who fulfill the inclusion criteria 1) age above 18, 2) require restoration on premolar/molar and 3) are able to come to treatment and recall, are informed about the study and invited to participate. Consent to participation are signed by the patient. At any time and for any reason participants can withdraw from the study.

Personal information will be registered in Service for Sensitive Data, which is a platform to collect, store, analyze and share sensitive data. An encoded research file will be kept separate from the patient journal.The content of this file will be patient journal number and classification of the restoration on a four level scale (Californian Dental Association - CDA) for each recall.

A randomizing tool will be used to decide which ceramic restoration each participant will receive. Treatment will be performed by one clinician. The tooth preparation will be with little retention, and preferably supragingival. For cementing the restorations a standardized protocol for a dual cure resin cement will be used.

Participants only have to pay for the dental technician expenses and will be the same amount regardless of type of ceramic.

Each participant will be examined at 3, 6, 12 and 24 months by a clinician different from the one who performed the treatment. The 4 level CDA classification will be used to characterise each restoration.

Each of the two treatment groups will consist of 20 participants. Significant results will be achieved with the approximate distribution across categories: Category 1: 19,9 %, category 2: 79,4 %, category 3: 4,6 %, category 4: 2,5 %

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0455
    • Institute of Clinical Dentistry, University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

18 years or older In the need of treatment on molars or premolars Lives near by Oslo

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Exclusion Criteria:

The patients that does not fulfill the inclusion criteria

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zirconia restorations; Dental restorations in surface modified zirconia bonded to tooth substance by dual cure resin cement	Other: Ceramic tooth restoration; Dental restorations
Active Comparator: e.max; Restorations in e.max bonded to tooth substance by dual cure resin cement	Other: Ceramic tooth restoration; Dental restorations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Restoration still retained to tooth	2 years
Loss of retention	Restoration not retained to tooth	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CDA-index: Romeo	Excellent: Surface smooth and glossy, no mismatch in color or shade	2 years
CDA-index: Sierra	Acceptable: SRO: Surface slightly rough or pitted, can be polished. SMM: slight mismatch in shade	2 years
CDA-index: Tango	Correct: TGI: surface glossy irregular, not subject to correction. TMM: mismatch between restoration and adjacent teeth outside normal range.	2 years
CDA-index: Victor	Replace: VSF: surface fractured. VGP: Gross porosities. VSD: shade in gross disharmony	2 years

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Nordic Institute of Dental Materials
• Investigators: Study Chair: Jan Eirik Ellingsen, Professor, Faculty of Dentistry, Institute of Clinical Dentistry

Publications and helpful links

General Publications

• Ruyter EI, Vajeeston N, Knarvang T, Kvam K. A novel etching technique for surface treatment of zirconia ceramics to improve adhesion of resin-based luting cements. Acta Biomater Odontol Scand. 2017 Apr 14;3(1):36-46. doi: 10.1080/23337931.2017.1309658. eCollection 2017 Jan.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 29, 2017
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Zirconium oxide; surface treatment; resin cement
• Other Study ID Numbers: 2016/957

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After termination of the study other researchers may use the database for further research

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No