Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:29 PM
Study NCT ID:
NCT07372105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-28
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the French Version of the SERQoL Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012904', 'term': 'Smiling'}], 'ancestors': [{'id': 'D005149', 'term': 'Facial Expression'}, {'id': 'D009633', 'term': 'Nonverbal Communication'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-20', 'studyFirstSubmitDate': '2026-01-20', 'studyFirstSubmitQcDate': '2026-01-20', 'lastUpdatePostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Measure of the internal consistency by the Cronbach's alpha", 'timeFrame': 'Day 15', 'description': "Measure of the questionnaire internal consistency by the Cronbach's alpha"}, {'measure': 'Measure of the test-retest reliability by the intraclass or Pearson correlation', 'timeFrame': 'Day 15', 'description': 'Measure of the questionnaire test-retest reliability by the intraclass or Pearson correlation'}, {'measure': 'Measure of the factor structure by the confirmatory factor analysis.', 'timeFrame': 'Day 15', 'description': 'Measure of the questionnaire factor structure by the confirmatory factor analysis'}], 'secondaryOutcomes': [{'measure': 'Average score measure by gender', 'timeFrame': 'Day 0', 'description': 'Average questionnaire score measure by gender'}, {'measure': 'Average score measure by age', 'timeFrame': 'Day 0', 'description': 'Average questionnaire score measure by gender'}, {'measure': 'Average score measure according to periodontal health status', 'timeFrame': 'Day 0', 'description': 'Average questionnaire score measure according to periodontal health status'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['smile esthetics', 'life quality', 'SERQoL', 'psychometric validation', 'patient-reported outcomes'], 'conditions': ['Smile', 'Smile Esthetics']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients attending their first periodontal consultation at the oral medicine departments of Rothschild Hospital (AP-HP) or Charles Foix Hospital (AP-HP)\n* Patients who speak and understand French well enough to read and understand the study information sheet.\n* Patients who are informed and do not object to participating in the study\n\nExclusion Criteria:\n\n* Patients under guardianship or curatorship\n* Patients who are completely edentulous, whether the edentulism is compensated or not\n\n * Patients with multiple dental agenesis (more than 6 teeth), amelogenesis, or syndromic or non-syndromic dentinogenesis imperfecta\n * Patients with psychiatric illnesses that may impact body image, such as patients with anorexia-bulimia or body dysmorphic disorder.'}, 'identificationModule': {'nctId': 'NCT07372105', 'acronym': 'Periosmile1', 'briefTitle': 'Validation of the French Version of the SERQoL Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Validation of the French Version of the Smile Esthetics-Related Quality of Life (SERQoL) Questionnaire', 'orgStudyIdInfo': {'id': 'APHP251033'}}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Suzanne DIMPRE, CCU-AAH', 'role': 'CONTACT', 'email': 'dr.dimpre@gmail.com', 'phone': '+33 (0)1 40 19 39 85'}], 'facility': 'Hôpital Rotschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Bruno TAVERNIER, PU-PH', 'role': 'CONTACT', 'email': 'bruno.tavernier@aphp.fr', 'phone': '+33 (0)1 40 19 39 85'}, {'name': 'Suzanne DIMPRE, CCU-AAH', 'role': 'CONTACT', 'email': 'dr.dimpre@gmail.com', 'phone': '00 33 1 40 19 39 85'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}