Treatment Result of Zirconia Laminate Veneer

NCT ID: NCT06406582

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Dislocation, Tooth Teeth, Endodontically-Treated Tooth Fracture Tooth Injuries Tooth Abnormalities Cracked Tooth Syndrome Tooth Crowding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Zirconia Group (Intervention): Participants receive zirconia laminate veneers. Lithium Disilicate Group (Control): Participants receive lithium disilicate laminate veneers. Lithium disilicate is a standard ceramic material for laminate veneers.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double-blind. Both participants and the outcomes assessor are kept unaware of which ceramic laminate veneer material (Zirconia or Lithium Disilicate) the participants are receiving

Study Groups

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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

Group Type EXPERIMENTAL

Zirconia laminate veneer

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Lithium Disilicate laminate veneer

Intervention Type 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).

Interventions

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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).

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanoi Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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High Technical Center of Dentistry, School of Dentistry

Hanoi, Hanoi, Vietnam

Site Status RECRUITING

Countries

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Vietnam

Facility Contacts

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Anh V Nguyen, DDS, MS

Role: primary

+84984822484

Other Identifiers

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01050122106

Identifier Type: -

Identifier Source: org_study_id

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