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Ceramic Tooth Restorations - a Comparison Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03517124
Recruitment Status : Unknown
Verified May 2018 by Hans Jacob Rønold, University of Oslo.
Recruitment status was:  Enrolling by invitation
First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Nordic Institute of Dental Materials
Information provided by (Responsible Party):
Hans Jacob Rønold, University of Oslo

Study Description
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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.


Condition or disease Intervention/treatment Phase
Dental Restoration Failure of Marginal Integrity Other: Ceramic tooth restoration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled clinical study
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: 2 years ]
    Restoration still retained to tooth

  2. Loss of retention [ Time Frame: 2 years ]
    Restoration not retained to tooth


Secondary Outcome Measures :
  1. CDA-index: Romeo [ Time Frame: 2 years ]
    Excellent: Surface smooth and glossy, no mismatch in color or shade

  2. CDA-index: Sierra [ Time Frame: 2 years ]
    Acceptable: SRO: Surface slightly rough or pitted, can be polished. SMM: slight mismatch in shade

  3. 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.

  4. CDA-index: Victor [ Time Frame: 2 years ]
    Replace: VSF: surface fractured. VGP: Gross porosities. VSD: shade in gross disharmony


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

-

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Norway
Institute of Clinical Dentistry, University of Oslo
Oslo, Norway, 0455
Sponsors and Collaborators
University of Oslo
Nordic Institute of Dental Materials
Investigators
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Study Chair: Jan Eirik Ellingsen, Professor Faculty of Dentistry, Institute of Clinical Dentistry
More Information
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Publications:

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Responsible Party: Hans Jacob Rønold, Associate Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT03517124    
Other Study ID Numbers: 2016/957
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After termination of the study other researchers may use the database for further research

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hans Jacob Rønold, University of Oslo:
Zirconium oxide
surface treatment
resin cement