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临床试验/NCT01724827
NCT01724827已完成3 期

Ceramic Versus Composite in the Treatment by Inlays or Onlays of Posterior Teeth Affected by Tooth Substance Loss : a Multicenter Randomized Controlled Trial

Assistance Publique - Hôpitaux de Paris9 个研究点 分布在 1 个国家目标入组 355 人开始时间: 2012年9月13日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
355
试验地点
9
主要终点
FDI criteria for dental restorations assessment

研究概览

简要总结

The main purpose of this trial is to determine which material, between ceramic and composite, is best to manufacture dental inlays and onlays in the treatment of moderate dental substance losses, generally due to dental caries. Restorations will be done using direct Computer Assisted Design and Manufacturing (CAD-CAM). Another aim of this study is to determine which factors influence the success of these restorations.

详细描述

WHO estimates dental caries prevalence to be over 90% adults worldwide. When tooth substance loss due to the decayed tissue is small, a filling is done by the dentist directly. When the substance loss is important, dentists often treat it with a crown, which presents the disadvantage of further mutilating the tooth. An intermediate technique consists in manufacturing an inlay or an onlay: these restorations become more and more common since they are a minimally invasive solution in such cases. Inlays and onlays can be made of metal, ceramic or composite. Patients tend to refuse metallic restorations, so that dentists generally have to choose between composite and ceramic. Composite wears whereas ceramics fracture. Published in vitro studies provide possible answers to which material is most effective but very few clinical studies have been conducted to confirm them. Material\'s choice for inlay manufacturing is thus more country-based than evidence-based (Most french dentists choose composite while US dentists prefer ceramics for example). The main objective of this trial is to compare the clinical performance of ceramic and composite inlays/onlays. Other objectives include looking for the prognostic factors of these restorations and validating the criteria proposed by the World Dental Federation (FDI) to evaluate dental restorations.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

ceramic

Active Comparator

Leucite-reinforced glass ceramic (Empress CAD, Ivoclar Vivadent)

干预措施: ceramic (Empress CAD, Ivoclar Vivadent) (Device)

composite

Active Comparator

Nanohybrid composite resin (Lava Ultimate, 3M Espe)

干预措施: composite (Lava Ultimate, 3M Espe) (Device)

结局指标

主要结局

FDI criteria for dental restorations assessment

时间窗: at 2 years

2 independent evaluators The primary outcome will consist in the FDI instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.

次要结局

  • FDI instrument validity data(at 2 years)
  • overall quality of the restoration(at 2 years)
  • Restoration survival analysis(at 2 years)
  • wear(at 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

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