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临床试验/NCT04927962
NCT04927962已完成不适用

Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta in Young People

University Hospital, Toulouse7 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2021年9月22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
87
试验地点
7
主要终点
Child Oral Health Impact Profile (COHIP)

研究概览

简要总结

The purpose of this research is to study the impact of dentinogenesis (DI) and amelogenesis (AI) imperfecta on oral quality of life, exposure to bullying and dental anxiety in a population of adolescents. WThe present study will use validated scales to evaluate the impact of bullying on the oral quality of live of youth aged 10 to 18 years, with non-syndromic DI or AI treated in seven national competence or reference centers in rare oral diseases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • be between 10 and 18 years of age,
  • consult for a care or follow-up consultation
  • having a non-syndromic amelogenesis imperfecta or dentinogenesis imperfecta
  • having access to a cell phone and/or tablet and/or personal or family computer
  • covered by the social security of one of his parents
  • understand French and one of whose parents (or legal representative) understands French
  • have declared his or her non-opposition and one of whose parents (or legal representative) has declared his or her non-opposition to participate in the study.

排除标准

  • Child presenting for diagnostic consultation and child who cannot read or whose 2 parents (legal representatives) cannot read

结局指标

主要结局

Child Oral Health Impact Profile (COHIP)

时间窗: Baseline

Difference between the average total COHIP questionnaire score of bullied and non bullied patients at D0 (no follow up is planned). A youth is considered bullied if he or she answers "three or more" at least once on the Bullying and Cyberbullying scale for Adolescent questionnaire)

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 (7)

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