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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wear of antagonist teeth to monolithic zirconia restorations | Experimental | Evaluate enamel wear antagonist to monolithic zirconia restorations monitoring the short and medium-term volume loss and assessing the factors that may influence this wear. |
|
| Wear of antagonist teeth to lithium disilicate restorations | Experimental | Evaluate enamel wear antagonist to lithium disilicate restorations monitoring the short and medium-term volume loss and assessing the factors that may influence this wear. |
|
| Wear of antagonist teeth to metalceramic restorations | Experimental | Evaluate enamel wear antagonist to metal ceramic restorations monitoring the short and medium-term volume loss and assessing the factors that may influence this wear. |
|
| Wear of natural enamel | Experimental | Evaluate physiological enamel wear (control group) monitoring the short short and medium-term volume loss and assessing the factors that may influence this wear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with monolithic zirconia restorations | Procedure | Treatment with monolithic zirconia restorations on teeth (single crowns). The sample (75 patients) will be divided into three groups according to the ceramic material used: monolithic zirconia, lithium disilicate and metal ceramic. |
| Measure | Description | Time Frame |
|---|---|---|
| Enamel volume loss | 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). | Through study completion, an average of two years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | To compare the survival between monolithic zirconia, lithium disilicate and metal ceramic restorations. | Through study completion, an average of two years |
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INCLUSION CRITERIA:
Inclusion criteria for abutment teeth:
EXCLUSION CRITERIA:
Exclusion criteria for abutment teeth:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mª Fernanda Solá Ruiz, Dentistry | Contact | 609048198 | +34 | m.fernanda.sola@uv.es |
| Name | Affiliation | Role |
|---|---|---|
| Mª Fernanda Solá Ruiz, Dentistry | University of Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mª Fernanda Solá Ruiz | Recruiting | Valencia | 46010 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2021 |
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This prospective study will include a sample "n" of 75 patients. Patients will be treated with single-tooth restorations with partial or complete veneering on the tooth. 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 sample will be randomised into one of the different groups using the online randomisation software www.alazarinfo.es. All patients will be pseudonymised, assigning each patient a number from 1 to 75 according to the chronology of incorporation into the study.
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|
| Treatment with lithium disilicate restorations | Procedure | Treatment with lithium disilicate restorations on teeth (single crowns). The sample (75 patients) will be divided into three groups according to the ceramic material used: monolithic zirconia, lithium disilicate and metal ceramic. |
|
| Treatment with metal ceramic restorations | Procedure | Treatment with metal ceramic restorations on teeth (single crowns). The sample (75 patients) will be divided into three groups according to the ceramic material used: monolithic zirconia, lithium disilicate and metal ceramic. |
|
| No intervention | Procedure | No intervention. |
|
| Jul 5, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2021 | Jul 5, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D057085 | Tooth Wear |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016876 | Metal Ceramic Alloys |
| ID | Term |
|---|---|
| D000497 | Alloys |
| D008670 | Metals |
| D007287 | Inorganic Chemicals |
| D001697 | Biomedical and Dental Materials |
| D003722 | Dental Alloys |
| D003764 | Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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