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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2017
CompletedStudy Start
First participant enrolled
January 5, 2018
CompletedFirst Posted
Study publicly available on registry
May 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMay 7, 2018
May 1, 2018
11 months
December 29, 2017
May 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Survival
Restoration still retained to tooth
2 years
Loss of retention
Restoration not retained to tooth
2 years
Secondary Outcomes (4)
CDA-index: Romeo
2 years
CDA-index: Sierra
2 years
CDA-index: Tango
2 years
CDA-index: Victor
2 years
Study Arms (2)
Zirconia restorations
EXPERIMENTALDental restorations in surface modified zirconia bonded to tooth substance by dual cure resin cement
e.max
ACTIVE COMPARATORRestorations in e.max bonded to tooth substance by dual cure resin cement
Interventions
Eligibility Criteria
You may qualify if:
- years or older In the need of treatment on molars or premolars Lives near by Oslo
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oslolead
- Nordic Institute of Dental Materialscollaborator
Study Sites (1)
Institute of Clinical Dentistry, University of Oslo
Oslo, 0455, Norway
Related Publications (1)
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.
PMID: 28642930BACKGROUND
Study Officials
- STUDY CHAIR
Jan Eirik Ellingsen, Professor
Faculty of Dentistry, Institute of Clinical Dentistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 29, 2017
First Posted
May 7, 2018
Study Start
January 5, 2018
Primary Completion
December 1, 2018
Study Completion
December 1, 2020
Last Updated
May 7, 2018
Record last verified: 2018-05