Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:32 AM
Study NCT ID:
NCT07482293
Status:
COMPLETED
Last Update Posted:
2026-03-24
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a French Version of the OHIP - Oral Health Impact Profile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants (n=200) will be asked to complete OHIP questionnaire at the end of their scheduled visit for periodontal treatment or follow-up.\n\nThe duration fullfilment is estimated at 10 minutes. The same questionnaire will be re-administered 15 days later at visit 2 (Retest), to one in two patients (n=100). If a second visit to the dental clinic is not necessary for the overall treatment plan, patients will be able to complete a paper questionnaire at home and return it by postal mail using a pre-stamped envelope or electronically (scanned questionnaire returned by e-mail).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire OHIP-fr', 'timeFrame': 'Baseline ; 15 days (if applicable)', 'description': 'Self administration of Oral Health Impact Profile questionnaire. The total score ranges from 0 to 196 (OHIP-49), with higher scores indicating worse oral health-related quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OHIP', 'oral health impact profile', 'quality of life', 'oral health', 'french version', 'OHIP 14', 'OHIP 49'], 'conditions': ['Oral Health Related Quality of Life (OHRQoL)']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is therefore to propose and validate a French-language (France) version of the OHIP (49 questions) (OHIP-fr-49: long version), and the secondary objective is to validate a shortened version, OHIP-fr-14.', 'detailedDescription': 'When patients are admitted to the study center, if they are seeking periodontal treatment, they may be asked to participate in the study. The control group consists of patients meeting inclusion and exclusion criteria and agreeing to participate. Participants will complete the questionnaire during their visit (test). The same questionnaire will be re-administrated 15 days later to the first 50 patients in each group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Native French speakers\n* Able to read and complete a questionnaire\n* Willing to take part in a study assessing perceived oral health\n\nPeriodontitis group: patients with periodontitis requiring specific treatment\n\nControl group: patients with at least 25 natural teeth and not suffering from periodontitis.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patients;\n* Patients under guardianship, curatorship, or judicial protection\n* Patients deprived of their liberty\n* Patients participating in another clinical trial.'}, 'identificationModule': {'nctId': 'NCT07482293', 'acronym': 'OHIP', 'briefTitle': 'Validation of a French Version of the OHIP - Oral Health Impact Profile', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Validation of a French Version of the OHIP - Oral Health Impact Profile', 'orgStudyIdInfo': {'id': 'RNI 2024 DOMEJEAN 2'}, 'secondaryIdInfos': [{'id': 'ANSM', 'type': 'OTHER', 'domain': '2024-A01904-43'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control group', 'description': 'Patients with at least 25 natural teeth and not suffering from periodontitis.', 'interventionNames': ['Other: OHIP']}, {'type': 'OTHER', 'label': 'Parodontisis group', 'description': 'Patients with periodontitis requiring specific treatment.', 'interventionNames': ['Other: OHIP']}], 'interventions': [{'name': 'OHIP', 'type': 'OTHER', 'description': 'Self-administration of the OHIP-49', 'armGroupLabels': ['Control group', 'Parodontisis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Sophie Doméjean', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Clermnt-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}