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Clinical Trials/NCT06406582
NCT06406582RecruitingNot Applicable

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

Hanoi Medical University2 sites in 1 country50 target enrollmentStarted: September 25, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
Marginal and internal fit

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Marginal and internal fit

Time Frame: Before veneer adhesion

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

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

Gingival health

Time Frame: 2 weeks, 6 months, 12 months

Assessment of gingival index

Periodontal pocket

Time Frame: 2 weeks, 6 months, 12 months

Measurement of periodontal pocket depth in millimeters

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hanoi Medical University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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