Enamel Wear Evaluation in Patients With Different Ceramic Restorations
NCT ID: NCT04963530
Last Updated: 2022-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
75 participants
INTERVENTIONAL
2021-03-01
2024-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
All-ceramic Restorations: a Retrospective and Prospective Study
NCT07110220
Digital Technique to Analyze the Wear of Implants and Natural Tooth as Antagonist.
NCT05842655
Wear Characteristics and Clinical Performance of Lithium Silicate Versus Monolithic Zirconia Crowns.
NCT03530020
Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis
NCT05637619
Prospective Clinical Trial of Onlay-carrying Patients
NCT04396080
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
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.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Wear of antagonist teeth to monolithic zirconia restorations
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.
Treatment with monolithic zirconia restorations
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.
Wear of antagonist teeth to lithium disilicate restorations
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.
Treatment with lithium disilicate restorations
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.
Wear of antagonist teeth to metalceramic restorations
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.
Treatment with metal ceramic restorations
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.
Wear of natural enamel
Evaluate physiological enamel wear (control group) monitoring the short short and medium-term volume loss and assessing the factors that may influence this wear.
No intervention
No intervention.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Treatment with monolithic zirconia restorations
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.
Treatment with lithium disilicate restorations
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
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
No intervention.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age range: between 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.
1. Posterior tooth requiring placement of a single tooth restoration. Restorability: with a crown:root ratio of at least 1:1.
2. The presence of an unrestored or minimally restored natural antagonist tooth (teeth with no more than a Class II restoration), in the same quadrant as the treated tooth (G1,2,3).
3. The presence of two unrestored or minimally restored antagonist teeth (in the same quadrants or on the contralateral side) (G4 or control).
4. Minimum height of the dental stump: 3mm.
Exclusion Criteria
2. Opposing arch with fixed or removable partial denture.
3. Lack of occlusal contact points in the enamel of the control teeth.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Valencia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mª Fernanda Solá Ruiz, Dentistry
Role: PRINCIPAL_INVESTIGATOR
University of Valencia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mª Fernanda Solá Ruiz
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
186205
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.