NCT04963530

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

June 1, 2021

Last Update Submit

May 31, 2022

Conditions

Wear, ToothDental WearProstheticOutcome

Keywords

Enamel wearMonolithic zirconiaLithium DisilicateMetal-ceramicSingle crowns

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Survival

    Through study completion, an average of two years

Study Arms (4)

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.

Procedure: Treatment with monolithic zirconia restorations

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.

Procedure: Treatment with lithium disilicate restorations

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.

Procedure: Treatment with metal ceramic restorations

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.

Procedure: No intervention

Interventions

Treatment with monolithic zirconia restorationsPROCEDURE

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 monolithic zirconia restorations
Treatment with lithium disilicate restorationsPROCEDURE

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 lithium disilicate restorations
Treatment with metal ceramic restorationsPROCEDURE

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 antagonist teeth to metalceramic restorations
No interventionPROCEDURE

No intervention.

Wear of natural enamel

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mª Fernanda Solá Ruiz

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Tooth Wear

Interventions

TherapeuticsMetal Ceramic Alloys

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AlloysMetalsInorganic ChemicalsBiomedical and Dental MaterialsDental AlloysDental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Mª Fernanda Solá Ruiz, Dentistry

    University of Valencia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mª Fernanda Solá Ruiz, Dentistry

CONTACT

609048198m.fernanda.sola@uv.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

July 15, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2024

Study Completion

May 1, 2024

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)