Ceramic Tooth Restorations - a Comparison Study
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|ClinicalTrials.gov Identifier: NCT03517124|
Recruitment Status : Enrolling by invitation
First Posted : May 7, 2018
Last Update Posted : May 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Dental Restoration Failure of Marginal Integrity||Other: Ceramic tooth restoration||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled clinical study|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Success and Survival of e.Max and KHF2 Etched Zirconia Cemented With Resin Cement - a Randomized Controlled Clinical Study|
|Actual Study Start Date :||January 5, 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2020|
Experimental: Zirconia restorations
Dental restorations in surface modified zirconia bonded to tooth substance by dual cure resin cement
Other: Ceramic tooth restoration
Active Comparator: e.max
Restorations in e.max bonded to tooth substance by dual cure resin cement
Other: Ceramic tooth restoration
- Survival [ Time Frame: 2 years ]Restoration still retained to tooth
- Loss of retention [ Time Frame: 2 years ]Restoration not retained to tooth
- CDA-index: Romeo [ Time Frame: 2 years ]Excellent: Surface smooth and glossy, no mismatch in color or shade
- CDA-index: Sierra [ Time Frame: 2 years ]Acceptable: SRO: Surface slightly rough or pitted, can be polished. SMM: slight mismatch in shade
- CDA-index: Tango [ Time Frame: 2 years ]Correct: TGI: surface glossy irregular, not subject to correction. TMM: mismatch between restoration and adjacent teeth outside normal range.
- CDA-index: Victor [ Time Frame: 2 years ]Replace: VSF: surface fractured. VGP: Gross porosities. VSD: shade in gross disharmony
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517124
|Institute of Clinical Dentistry, University of Oslo|
|Oslo, Norway, 0455|
|Study Chair:||Jan Eirik Ellingsen, Professor||Faculty of Dentistry, Institute of Clinical Dentistry|