Treatment Result of Zirconia Laminate Veneer

NCT06406582 | Recruiting

• 1 other identifier: 01050122106
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

ceramic laminate veneers; zirconia; lithium disilicate; computer-aided manufacturing

Outcome Measures

Primary Outcomes (4)

• Marginal and internal fit

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

  Before veneer adhesion

• Gingival health

  Assessment of gingival index

  2 weeks, 6 months, 12 months

• Periodontal pocket

  Measurement of periodontal pocket depth in millimeters

  2 weeks, 6 months, 12 months

• 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

Study Arms (2)

Zirconia laminate veneer

EXPERIMENTAL

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

Lithium Disilicate laminate veneer

ACTIVE COMPARATOR

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

Interventions

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).

Zirconia laminate veneer

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).

Lithium Disilicate laminate veneer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

High Technical Center of Dentistry, School of Dentistry

Hanoi, Hanoi, 10000, Vietnam

RECRUITING

MeSH Terms

Conditions

Tooth Avulsion; Tooth, Nonvital; Tooth Fractures; Tooth Injuries; Tooth Abnormalities; Cracked Tooth Syndrome; Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries; Dental Pulp Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 9, 2024
• Study Start: September 25, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 13, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)