Enamel Wear Evaluation in Patients With Different Ceramic Restorations

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

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.

Study Overview

• Status: Recruiting
• Conditions: Outcome; Wear, Tooth; Dental Wear; Prosthetic
• Intervention / Treatment: Procedure: Treatment with monolithic zirconia restorations; Procedure: Treatment with lithium disilicate restorations; Procedure: Treatment with metal ceramic restorations; Procedure: No intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mª Fernanda Solá Ruiz, Dentistry; Phone Number: +34 609048198; Email: m.fernanda.sola@uv.es

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Recruiting
    • Mª Fernanda Solá Ruiz
    • Contact: Mª Fernanda Solá Ruiz, Dentistry; Phone Number: +34 609048198; Email: m.fernanda.sola@uv.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA:

• Patients in need of single tooth restorations on posterior teeth.
• 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.

Inclusion criteria for abutment teeth:

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:

Exclusion criteria for abutment teeth:

1. Antagonist tooth with a full coverage restoration.
2. Opposing arch with fixed or removable partial denture.
3. Lack of occlusal contact points in the enamel of the control teeth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Experimental: 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.	Procedure: 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.
Experimental: 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.	Procedure: 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.
Experimental: 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.	Procedure: No intervention; No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Mª Fernanda Solá Ruiz, Dentistry, University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Enamel wear; Monolithic zirconia; Lithium Disilicate; Metal-ceramic; Single crowns
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Wear; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: 186205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No