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Clinical Trials/NCT04963530
NCT04963530
Unknown
Not Applicable

Wear Evaluation of Antagonist Enamel to Monolithic Zirconia, Lithium Disilicate and Metal-ceramic Restorations. Prospective Randomised Study

University of Valencia1 site in 1 country75 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Wear, Tooth
Sponsor
University of Valencia
Enrollment
75
Locations
1
Primary Endpoint
Enamel volume loss
Last Updated
3 years ago

Overview

Brief Summary

The aim of this study is to evaluate the wear produced in the short and medium term by monolithic zirconia, metal-ceramic and lithium disilicate restorations on the antagonist natural enamel in patients with fixed prostheses, assessing the factors that may influence this wear.

The investigators will also analyse whether the wear of the tooth antagonistic to the different restorations differs significantly with respect to the wear of the natural tooth (control group). The null hypothesis is that there are no significant differences.

Detailed Description

The study will be carried out on patients who will be candidates for treatment with full coverage restorations on teeth (single crowns). These crowns will be made of one of the following materials: monolithic zirconia, lithium disilicate or metal-ceramic, which will be cemented according to the guidelines defined in the scientific literature. Inclusion criteria will be: patients in need of full coverage crowns on a first or second premolar or first or second molar in any arch, over 18 years of age, no contraindications for dental treatment, good oral hygiene, no periodontal disease or treated periodontal disease, absence of temporomandibular disorder and/or untreated habits or parafunctions. The aim of this study is to evaluate the wear produced in the short and medium term by monolithic zirconia, metal-ceramic and lithium disilicate restorations on the antagonist tooth in patients with fixed prostheses, assessing the factors that may influence this wear. The investigators will also analyse whether the wear of the tooth antagonistic to the different restorations differs significantly with respect to the wear of the natural tooth (control group). The null hypothesis is that there are no significant differences. Once the treatment has been completed, the patient must attend routine check-ups in which a complete intraoral exploration, a scan and data collection for both arches will be carried out in order to analyse the following variables: wear of the antagonist tooth to ceramic restorations, wear of the restoration itself and physiological wear of the natural tooth. The same intervention will be carried out for the duration of the project, at the following time intervals: baseline (day of cementation of the restoration), 1 month, 6 months and annually. If an intraoral scanner is not available, silicone impressions will be made, which will be cast with plaster and scanned extraorally. The investigators will work with a sample "n" of 75 patients, collected over the next two years. Depending on the material used to fabricate the restoration, 4 different groups will be differentiated: monolithic zirconia (group 1), metal-ceramic (group 2), lithium disilicate (group 3) and natural tooth (control group). The patients will be randomly distributed into the different groups using the online randomisation software www.alazarinfo.es.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
May 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Enamel volume loss

Time Frame: Through study completion, an average of two years

Analyse volume loss of enamel antagonist to monolithic zirconia, lithium disilicate and metal ceramic restorations. The investigators will also analyse whether the wear of the tooth antagonistic to the different restorations differs significantly with respect to the physiological wear of the natural tooth (control group).

Secondary Outcomes

  • Survival(Through study completion, an average of two years)

Study Sites (1)

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