跳至主要内容
临床试验/NCT03854526
NCT03854526已完成不适用

Evaluation of Direct and Indirect Partial Dental Coronal Restorations Within a Dental Practice-based Research Network and a Set of Hospital-university Odontology Services

Hospices Civils de Lyon61 个研究点 分布在 1 个国家目标入组 863 人开始时间: 2019年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
863
试验地点
61
主要终点
Status of coronary obturation with a simplified notation a, b or c

研究概览

简要总结

The purpose of this study is to provide the latest information on the oral health status of patients, the lifetime of restorations, to quantify the incidence of defects rates on inserted restorations in conservative dentistry. Moreover, the study permits to compare needs of two different patient populations depending on the place of consultation (those consulting in hospital services and those consulting in private structures) and to compare the quality of coronary fillings in patients with of Gougerot Sjogren disease and those not affected.

A minimum sample of 840 adult subjects consecutively seen at the investigator's office over a period of 33 months is expected ; 400 subjects included in private structures and 440 subjected included in university hospital services (8 to 15 patients per investigator), including at least 40 patients with Gougerot Sjogren disease (disease prevalence = 0.1%).

The investigators of these study are 46 dentists working in private dental practices or private structures of dental care spread over the " Ile-de-France " and " Rhône-Alpes Auvergne " régions and 43 dentists working in 13 french university hospital services in odontology, including two hosting one consultation for Gougerot Sjogren disease, from the ReCOL network (Recherche Clinique en Odontologie Libérale).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patient having read and signed the information letter attesting to his/her non-opposition
  • Affiliated to a social security scheme
  • Patient over 18 years old
  • New patient in the practice or in the hospital service, that can be a classical odontalogical service or a consultation specializing in Gougerot Sjogren disease, with no history of a dental examination less than six months old, or Patient who has not consulted in the last six months
  • Patient with at least one tooth with partial coronal restoration

排除标准

  • Patient under tutorship or curatorship

结局指标

主要结局

Status of coronary obturation with a simplified notation a, b or c

时间窗: At day 0

notation is based on FDI (World Dental Federation) criteria

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (61)

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