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Not yet recruiting NCT07372105

Validation of the French Version of the SERQoL Questionnaire

Observational Smile Smile Esthetics

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Smile, Smile Esthetics. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

  • Measure of the internal consistency by the Cronbach's alpha [Time frame: Day 15]
  • Measure of the test-retest reliability by the intraclass or Pearson correlation [Time frame: Day 15]
  • Measure of the factor structure by the confirmatory factor analysis. [Time frame: Day 15]
Secondary outcome measures (3)
  • Average score measure by gender [Time frame: Day 0]
  • Average score measure by age [Time frame: Day 0]
  • Average score measure according to periodontal health status [Time frame: Day 0]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Hôpital Rotschild — Paris

Identifiers

NCT: NCT07372105 · APHP251033

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗