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临床试验/NCT07372105
NCT07372105尚未招募不适用

Validation of the French Version of the Smile Esthetics-Related Quality of Life (SERQoL) Questionnaire

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Measure of the internal consistency by the Cronbach's alpha

研究概览

简要总结

This observational study aims to validate the French version of the Smile Esthetics-Related Quality of Life (SERQoL) questionnaire in adult patients recruited in two APH-HP dental departments. The study evaluates internal consistency, test-retest reliability, and construct validity of the questionnary. A total of 120 patients will be recruited from dental departments at two AP-HP hospitals.

详细描述

This psychometric validation study involves adult patients receiving their first consultation at AP-HP dental services. The SERQoL questionnaire will be completed twice (at baseline and after 15 days). Internal consistency (Cronbach's alpha), test-retest reliability (intraclass or Pearson correlation), and factor structure (confirmatory factor analysis) will be analyzed. No clinical intervention is involved, and participation will not alter standard care.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Age ≥ 18 years
  • Patients attending their first periodontal consultation at the oral medicine departments of Rothschild Hospital (AP-HP) or Charles Foix Hospital (AP-HP)
  • Patients who speak and understand French well enough to read and understand the study information sheet.
  • Patients who are informed and do not object to participating in the study

排除标准

  • Patients under guardianship or curatorship
  • Patients who are completely edentulous, whether the edentulism is compensated or not
  • Patients with multiple dental agenesis (more than 6 teeth), amelogenesis, or syndromic or non-syndromic dentinogenesis imperfecta
  • Patients with psychiatric illnesses that may impact body image, such as patients with anorexia-bulimia or body dysmorphic disorder.

结局指标

主要结局

Measure of the internal consistency by the Cronbach's alpha

时间窗: Day 15

Measure of the questionnaire internal consistency by the Cronbach's alpha

Measure of the test-retest reliability by the intraclass or Pearson correlation

时间窗: Day 15

Measure of the questionnaire test-retest reliability by the intraclass or Pearson correlation

Measure of the factor structure by the confirmatory factor analysis.

时间窗: Day 15

Measure of the questionnaire factor structure by the confirmatory factor analysis

次要结局

  • Average score measure by gender(Day 0)
  • Average score measure by age(Day 0)
  • Average score measure according to periodontal health status(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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