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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03517124
Enrollment
40
Registered
2018-05-07
Start date
2018-01-05
Completion date
2020-12-31
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Restoration Failure of Marginal Integrity

Keywords

Zirconium oxide, surface treatment, resin cement

Brief summary

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.

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 %

Interventions

OTHERCeramic tooth restoration

Dental restorations

Sponsors

Nordic Institute of Dental Materials
CollaboratorUNKNOWN
University of Oslo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Randomized controlled clinical study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

The patients that does not fulfill the inclusion criteria \-

Design outcomes

Primary

MeasureTime frameDescription
Survival2 yearsRestoration still retained to tooth
Loss of retention2 yearsRestoration not retained to tooth

Secondary

MeasureTime frameDescription
CDA-index: Romeo2 yearsExcellent: Surface smooth and glossy, no mismatch in color or shade
CDA-index: Sierra2 yearsAcceptable: SRO: Surface slightly rough or pitted, can be polished. SMM: slight mismatch in shade
CDA-index: Tango2 yearsCorrect: TGI: surface glossy irregular, not subject to correction. TMM: mismatch between restoration and adjacent teeth outside normal range.
CDA-index: Victor2 yearsReplace: VSF: surface fractured. VGP: Gross porosities. VSD: shade in gross disharmony

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026