SmilePeriosmile1NCT07372105
Validation of the French Version of the SERQoL Questionnaire
An observational study of Smile and Smile Esthetics, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smile, Smile Esthetics
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2026to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Rotschild
Paris, 75012
Suzanne DIMPRE, CCU-AAH, +33 (0)1 40 19 39 85, dr.dimpre@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Smile, Smile Esthetics
- Keywords
- smile esthetics, life quality, SERQoL, psychometric validation, patient-reported outcomes
- Medical subject headings
- Smiling
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the internal consistency by the Cronbach's alpha
Measure of the questionnaire internal consistency by the Cronbach's alpha
Measured: Day 15
Measure of the test-retest reliability by the intraclass or Pearson correlation
Measure of the questionnaire test-retest reliability by the intraclass or Pearson correlation
Measured: Day 15
Measure of the factor structure by the confirmatory factor analysis.
Measure of the questionnaire factor structure by the confirmatory factor analysis
Measured: Day 15
Secondary outcomes (3)
Average score measure by gender
Average questionnaire score measure by gender
Measured: Day 0
Average score measure by age
Average questionnaire score measure by gender
Measured: Day 0
Average score measure according to periodontal health status
Average questionnaire score measure according to periodontal health status
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmileStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372105
- Sponsor's protocol ID
- APHP251033
- Acronym
- Periosmile1
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the Smile Esthetics-Related Quality of Life (SERQoL) Questionnaire
- ClinicalTrials.gov ID
- NCT07372105
- Acronym / sponsor ID
- Periosmile1 / APHP251033
- Conditions
- Smile, Smile Esthetics
- Keywords
- smile esthetics, life quality, SERQoL, psychometric validation, patient-reported outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Patients under guardianship or curatorship
- Patients who are completely edentulous, whether the edentulism is compensated or not
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smile and Smile Esthetics, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno TAVERNIER, PU-PH (+33 (0)1 40 19 39 85, bruno.tavernier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the internal consistency by the Cronbach's alpha (time frame: Day 15). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.