Validation of the French Version of the SERQoL Questionnaire (Periosmile1)

January 20, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75012
        • Hôpital Rotschild
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients attending a first consultation in the dental department of Rothschild or Charles Foix hospitals (AP-HP). Participants must speak and understand French and have not opposed participation.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of the internal consistency by the Cronbach's alpha
Time Frame: Day 15
Measure of the questionnaire internal consistency by the Cronbach's alpha
Day 15
Measure of the test-retest reliability by the intraclass or Pearson correlation
Time Frame: Day 15
Measure of the questionnaire test-retest reliability by the intraclass or Pearson correlation
Day 15
Measure of the factor structure by the confirmatory factor analysis.
Time Frame: Day 15
Measure of the questionnaire factor structure by the confirmatory factor analysis
Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average score measure by gender
Time Frame: Day 0
Average questionnaire score measure by gender
Day 0
Average score measure by age
Time Frame: Day 0
Average questionnaire score measure by gender
Day 0
Average score measure according to periodontal health status
Time Frame: Day 0
Average questionnaire score measure according to periodontal health status
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP251033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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