Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:47 PM
Study NCT ID:
NCT06464003
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2024-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Orthodontic Screening in Public Healthcare
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2024-06-06', 'studyFirstSubmitQcDate': '2024-06-14', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment need', 'timeFrame': 'Baseline', 'description': 'Orthodontic treatment need'}], 'secondaryOutcomes': [{'measure': 'Subjective evaluation', 'timeFrame': 'Baseline', 'description': 'A questionnaire enquiring subjective evaluation of the treatment need and impact of malocclusion on oral heath related quality of life'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malocclusion', 'Compliance, Patient']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine orthodontic screening practises in public health care.', 'detailedDescription': 'The study aims to assess repeatability of malocclusion evaluation in orthodontic treatment need screening in a publicly funded clinic. The objective treatment need is compared with subjective need for orthodontic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Unselected population sample study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residence in the wellbeing services county catchment area\n* willingness to participate in the study\n\nExclusion Criteria:\n\n* Age under 6 years or over 16 years\n* insufficient language skills to be able to understand the questionnaire'}, 'identificationModule': {'nctId': 'NCT06464003', 'briefTitle': 'Orthodontic Screening in Public Healthcare', 'organization': {'class': 'OTHER', 'fullName': 'University of Helsinki'}, 'officialTitle': 'Orthodontic Screening and Treatment Need in Public Health Care', 'orgStudyIdInfo': {'id': 'UHelsinki'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment need', 'description': 'Individuals with objective treatment need', 'interventionNames': ['Other: Questionnaire']}, {'label': 'No treatment need', 'description': 'Individuals with no objectively determined treatment need', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Controls', 'description': 'Random sample of individuals', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Malocclusion impact questionnaire', 'armGroupLabels': ['Controls', 'No treatment need', 'Treatment need']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'FI-00014', 'city': 'Helsinki', 'state': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Heidi Arponen, DDS', 'role': 'CONTACT', 'email': 'heidi.arponen@helsinki.fi'}], 'facility': 'University of Helsinki', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '01030', 'city': 'Vantaa', 'state': 'Vantaa', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Heidi Arponen', 'role': 'CONTACT'}], 'facility': 'Vantaa and Kerava wellbeing services county', 'geoPoint': {'lat': 60.29414, 'lon': 25.04099}}], 'centralContacts': [{'name': 'Heidi Arponen', 'role': 'CONTACT', 'email': 'Heidi.arponen@helsinki.fi', 'phone': '+3582941911'}, {'name': 'Heidi Arponen', 'role': 'CONTACT', 'phone': '+3582941911'}], 'overallOfficials': [{'name': 'Heidi Arponen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Helsinki'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Helsinki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant orthodontist', 'investigatorFullName': 'Heidi Arponen', 'investigatorAffiliation': 'University of Helsinki'}}}}