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Enamel Wear Evaluation in Patients With Different Ceramic Restorations

Primary Purpose

Wear, Tooth, Dental Wear, Prosthetic

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Treatment with monolithic zirconia restorations
Treatment with lithium disilicate restorations
Treatment with metal ceramic restorations
No intervention
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wear, Tooth focused on measuring Enamel wear, Monolithic zirconia, Lithium Disilicate, Metal-ceramic, Single crowns

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mª Fernanda Solá RuizRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Wear of antagonist teeth to monolithic zirconia restorations

Wear of antagonist teeth to lithium disilicate restorations

Wear of antagonist teeth to metalceramic restorations

Wear of natural enamel

Arm Description

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.

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.

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.

Evaluate physiological enamel wear (control group) monitoring the short short and medium-term volume loss and assessing the factors that may influence this wear.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Survival
To compare the survival between monolithic zirconia, lithium disilicate and metal ceramic restorations.

Full Information

First Posted
June 1, 2021
Last Updated
May 31, 2022
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT04963530
Brief Title
Enamel Wear Evaluation in Patients With Different Ceramic Restorations
Official Title
Wear Evaluation of Antagonist Enamel to Monolithic Zirconia, Lithium Disilicate and Metal-ceramic Restorations. Prospective Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wear, Tooth, Dental Wear, Prosthetic, Outcome
Keywords
Enamel wear, Monolithic zirconia, Lithium Disilicate, Metal-ceramic, Single crowns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wear of antagonist teeth to monolithic zirconia restorations
Arm Type
Experimental
Arm Description
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.
Arm Title
Wear of antagonist teeth to lithium disilicate restorations
Arm Type
Experimental
Arm Description
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.
Arm Title
Wear of antagonist teeth to metalceramic restorations
Arm Type
Experimental
Arm Description
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.
Arm Title
Wear of natural enamel
Arm Type
Experimental
Arm Description
Evaluate physiological enamel wear (control group) monitoring the short short and medium-term volume loss and assessing the factors that may influence this wear.
Intervention Type
Procedure
Intervention Name(s)
Treatment with monolithic zirconia restorations
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Treatment with lithium disilicate restorations
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Treatment with metal ceramic restorations
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
No intervention
Intervention Description
No intervention.
Primary Outcome Measure Information:
Title
Enamel volume loss
Description
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).
Time Frame
Through study completion, an average of two years
Secondary Outcome Measure Information:
Title
Survival
Description
To compare the survival between monolithic zirconia, lithium disilicate and metal ceramic restorations.
Time Frame
Through study completion, an average of two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Posterior tooth requiring placement of a single tooth restoration. Restorability: with a crown:root ratio of at least 1:1. 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). The presence of two unrestored or minimally restored antagonist teeth (in the same quadrants or on the contralateral side) (G4 or control). Minimum height of the dental stump: 3mm. EXCLUSION CRITERIA: Exclusion criteria for abutment teeth: Antagonist tooth with a full coverage restoration. Opposing arch with fixed or removable partial denture. Lack of occlusal contact points in the enamel of the control teeth.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mª Fernanda Solá Ruiz, Dentistry
Phone
609048198
Ext
+34
Email
m.fernanda.sola@uv.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mª Fernanda Solá Ruiz, Dentistry
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mª Fernanda Solá Ruiz
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mª Fernanda Solá Ruiz, Dentistry
Phone
609048198
Ext
+34
Email
m.fernanda.sola@uv.es

12. IPD Sharing Statement

Plan to Share IPD
No

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Enamel Wear Evaluation in Patients With Different Ceramic Restorations

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