Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2018-01-05
2020-12-31
Brief Summary
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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.
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Detailed Description
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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 %
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Zirconia restorations
Dental restorations in surface modified zirconia bonded to tooth substance by dual cure resin cement
Ceramic tooth restoration
Dental restorations
e.max
Restorations in e.max bonded to tooth substance by dual cure resin cement
Ceramic tooth restoration
Dental restorations
Interventions
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Ceramic tooth restoration
Dental restorations
Eligibility Criteria
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Inclusion Criteria
\-
\-
18 Years
ALL
Yes
Sponsors
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Nordic Institute of Dental Materials
UNKNOWN
University of Oslo
OTHER
Responsible Party
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Hans Jacob Rønold
Associate Professor
Principal Investigators
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Jan Eirik Ellingsen, Professor
Role: STUDY_CHAIR
Faculty of Dentistry, Institute of Clinical Dentistry
Locations
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Institute of Clinical Dentistry, University of Oslo
Oslo, , Norway
Countries
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References
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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.
Other Identifiers
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2016/957
Identifier Type: -
Identifier Source: org_study_id
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