Treatment Result of Zirconia Laminate Veneer

February 11, 2025 updated by: Hanoi Medical University

Surface Conditioning Effectiveness, Accuracy and Treatment Result of Zirconia Laminate Veneer

This study aims to evaluate the clinical performance of the zirconia laminate veneer, a minimally invasive prosthetic restoration

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with indications for single tooth restoration with ceramic laminate veneers are recruited for the study. These indications include spaced, discolored, malformed, root canal-treated, chipped, and mildly crowded teeth. After providing written informed consent, all patients are randomly divided into two groups in a double-blind manner (participants and the outcomes assessor) in a 1:1 ratio, including the Zirconia group (intervention) and the Lithium Disilicate group (control). Each patient's tooth is prepared and restored with the corresponding laminate veneer material, that is, zirconia and lithium disilicate.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam, 10000
        • Recruiting
        • High Technical Center of Dentistry, School of Dentistry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Spaced tooth
  • Discolored tooth
  • Malformed tooth
  • Root canal-treated tooth
  • Chipped tooth
  • Mildly crowded tooth

Exclusion Criteria:

  • Tooth bruxism
  • Inadequate enamel for bonding
  • Large restoration exists
  • Bad oral habits harming restoration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zirconia laminate veneer

Intervention: Single-tooth restoration using zirconia ceramic laminate veneers.

Procedure:

Tooth preparation following standard protocols for laminate veneer placement. Fabrication of zirconia laminate veneers. Cementation of zirconia laminate veneers with appropriate bonding protocol. Follow-Up: after 2 weeks, 6 months, and 12 months
Device: Zirconia laminate veneer
Zirconia veneers are milled with computer-aided manufacturing technology from multilayered zirconia discs with shade matched with adjacent teeth. After sintering, veneer surfaces are treated with a hydrofluoric acid-nitric acid mixture. Next, veneers are cut back if necessary to provide space for characterization. Veneers are bonded with a light-cured veneer adhesive system (Relyx Veneer LC, 3M, USA).
Active Comparator: Lithium Disilicate laminate veneer

Intervention: Single-tooth restoration using lithium disilicate ceramic laminate veneers.

Procedure:

Tooth preparation following standard protocols for laminate veneer placement. Fabrication of lithium disilicate laminate veneers. Cementation of lithium disilicate laminate veneers with appropriate bonding protocol.

Follow-Up: after 2 weeks, 6 months, and 12 months
Device: Lithium Disilicate laminate veneer
Lithium Disilicate veneers are milled with computer-aided manufacturing technology from lithium disilicate blocks with shade matched with adjacent teeth. After sintering, veneer surfaces are treated with hydrofluoric acid. Next, veneers are cut back if necessary to provide space for characterization. Veneers are bonded with a light-cured veneer adhesive system (Relyx Veneer LC, 3M, USA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal and internal fit
Time Frame: Before veneer adhesion
Measurement of marginal and internal fit in micrometers with silicone replica method
Before veneer adhesion
Gingival health
Time Frame: 2 weeks, 6 months, 12 months
Assessment of gingival index
2 weeks, 6 months, 12 months
Periodontal pocket
Time Frame: 2 weeks, 6 months, 12 months
Measurement of periodontal pocket depth in millimeters
2 weeks, 6 months, 12 months
Evaluation criteria based on the modified United States Public Health Standard
Time Frame: 2 weeks, 6 months, 12 months
Shade match, contour, fracture, loss of retention, hypersensitivity
2 weeks, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanoi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01050122106

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tooth Abnormalities

Clinical Trials on Zirconia laminate veneer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe