Dental Prosthesis Failure
Conditions
Keywords
all ceramic, zirconia, crown, clinal trial
Brief summary
This is a randomized, prospective clinical trial. The aim of the project is to assess the clinical performance of three types of tooth-supported crowns; monolithic high translucent colored zirconia, crowns of high-translucent colored zirconia with a mini-veneer buccally and crowns of lithium-disilicate glass-ceramic. Crowns will be placed on posterior teeth and evaluated from an esthetic and functional point of view, to identify if there are any differences between the materials.
Detailed description
90 monolithic tooth-supported crowns are planned to be included in the study; 30 crowns of high translucent zirconia (BruxZir, Glidewell), 30 crowns of high translucent zirconia (BruxZir, Glidewell) with a mini-veneer of porcelain and 30 crowns of lithium-disilicate glass-ceramic (IPS e.max CAD, Ivoclar Vivadent AG, Schaan, Liechtenstein). Patients with indications for single crowns will be recruited from three general dental clinics. Inclusion criteria for participating in this study are patients in need of crowns in the posterior dentition, premolars and molars. Exclusion criteria are patients with high caries activity/risk for caries and/or advanced periodontal disease. Patients who meet the criteria will be offered the opportunity to participate in the study. They will receive written information about the study design, clinical procedures and the materials and methods to be used. Patients who are interested will confirm their participation by a written consent. The patients will be offered an extended warranty for the crowns in case of failure. The study has been approved by the Regional Ethical Board in Lund, Sweden
Interventions
COMBINATION_PRODUCTIPS e.max CAD, Ivoclar Vivadent
Type: monolithic lithium-disilicate glass ceramic
COMBINATION_PRODUCTBruxZir, Glidewell
Type: high translucent zirconia
COMBINATION_PRODUCTBruxZir*, Glidewell
Type: high translucent zirconia with a mini-veneer of porcelain
Sponsors
Malmö University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* need of one or more dental crowns in the posterior dentition, premolars and molars
Exclusion criteria
* high caries activity/risk for caries and/or advanced periodontal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical perfomance | 12 month | To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system. |
| Clinical performance | 120 months | To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient questionnaire | 12 month | Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied'). |
Countries
Sweden
Contacts
STUDY_CHAIRChristel Larsson, PhD
Malmö University
Outcome results
None listed