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OpenTrials
Completed

NCT Number: NCT06406582

Treatment Result of Zirconia Laminate Veneer

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

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Key information

Conditions

Dislocation, Tooth Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cracked Tooth Syndrome Dental Pulp Diseases Malocclusion Stomatognathic Diseases Stomatognathic System Abnormalities Teeth, Endodontically-Treated Tooth Abnormalities Tooth Avulsion Tooth Crowding Tooth Diseases Tooth Fracture Tooth Fractures Tooth Injuries Tooth, Nonvital Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

High Technical Center of Dentistry, School of Dentistry

Hanoi, 10000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zirconia laminate veneer

Device

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).

Lithium Disilicate laminate veneer

Device

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).

Primary outcomes

  1. Marginal and internal fit

    Time frame: Before veneer adhesion

    Measurement of marginal and internal fit in micrometers with silicone replica method

  2. Gingival health

    Time frame: 2 weeks, 6 months, 12 months

    Assessment of gingival index

  3. Periodontal pocket

    Time frame: 2 weeks, 6 months, 12 months

    Measurement of periodontal pocket depth in millimeters

  4. 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

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 9, 2024
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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