Treatment Result of Zirconia Laminate Veneer

Teeth, Endodontically-Treated Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06406582
• Other study ID #: 01050122106
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Hanoi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 single-blind manner (participant) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Teeth, Endodontically-Treated
• Tooth Abnormalities
• Tooth Avulsion
• Tooth Crowding
• Tooth Fracture
• Tooth Fractures
• Tooth Injuries
• Tooth, Nonvital

Intervention

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).
• 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).

Locations

Country	Name	City	State
Vietnam	High Technical Center of Dentistry, School of Dentistry	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Hanoi Medical University

Country where clinical trial is conducted

Vietnam, 

Outcome

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