Dental Restoration Failure of Marginal Integrity Clinical Trial
Official title:
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.
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 %
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