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临床试验/NCT06406582
NCT06406582招募中不适用

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

Hanoi Medical University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Marginal and internal fit

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Marginal and internal fit

时间窗: 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

时间窗: 2 weeks, 6 months, 12 months

Shade match, contour, fracture, loss of retention, hypersensitivity

Gingival health

时间窗: 2 weeks, 6 months, 12 months

Assessment of gingival index

Periodontal pocket

时间窗: 2 weeks, 6 months, 12 months

Measurement of periodontal pocket depth in millimeters

次要结局

未报告次要终点

研究者

发起方
Hanoi Medical University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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