Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT06905067
Status:
COMPLETED
Last Update Posted:
2025-08-14
First Post:
2025-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Oral Health in Minors Incarcerated at Fleury Merogis: Retrospective Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decayed missing filled permanent teeth index (DMFT', 'timeFrame': 'at day 0', 'description': 'Number of decayed, missing and filled permanent teeth'}], 'secondaryOutcomes': [{'measure': 'Frequency of brushing and presence of absence of snacking', 'timeFrame': 'at day 0', 'description': 'Assess oral hygiene and dietary habits'}, {'measure': 'NRS scale', 'timeFrame': 'at day 0', 'description': 'NRS (numeric rating scale) : A score of 0 means no pain, and 10 means the worst pain you have ever felt.'}, {'measure': 'Presence of oral pathology defined by a DMFT index > 0', 'timeFrame': 'at day 0', 'description': 'Assess oral pathologies in incarcerated minors'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental caries', 'DMF index', 'oral health', 'oral hygiene', 'humans', 'adolescent', 'jails', 'prisoners', 'young adult', 'male', 'prevalence', 'france', 'epidemiology', 'retrospective studies', 'observational studies as topic'], 'conditions': ['DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to assess the oral health of males juveniles incarcerated at Fleury-Mérogis over a given period.\n\nThe goal is also to understand the needs of these patients and improve their care in prison while raising awareness about oral health to achieve lasting results.\n\nHypothesis: Incarcerated juveniles often grew up in precarious conditions. Is their DMFT (decayed, missing, filled permanent teeth) index higher than the "standard" juvenile population? Public interest: Understanding the needs of these juvenile patients, public health data.\n\nBy comparing our results to those of the "standard" population (non-incarcerated minors) through a literature review regarding the DMFT index in these patients, we will determine whether incarcerated juvenile patients represent a population at risk of developing oral pathologies. Oral disease prevention for these patients to raise awareness of the importance of oral hygiene and follow-up dental appointments outside of the prison system. The earlier these patients are educated, the greater the chance they will develop better habits throughout their lives.', 'detailedDescription': 'This is a retrospective observational study in which we will collect data from the first dental consultation between June 2024 and December 2024.\n\nThe primary objective is to assess the oral health of minors incarcerated at Fleury-Mérogis using the primary outcome measure, the DMFT index.\n\n77 male minors are included in the study. Data will be collected retrospectively by the research team from their medical records.\n\nThe data will be collected by the research team in a pseudo-anonymized form in an electronic CRF (case report form) and then analyzed by the biostatistician at the Clinical Research Unit of the Centre Hospitalier Sud Francilien.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'male minors incarcerated in Fleury-Mérogis over the study period (between June 2024 and December 2024)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male minor patients incarcerated at the Fleury-Mérogis Prison between June 2024 and December 2024\n* Patients who have had a dental check-up\n\nExclusion Criteria:\n\n\\- Patients and/or those with parental authority who have been informed and have objected to the use of their data.- Female patients and/or those with parental authority over the newborn who have objected to the use of their data.'}, 'identificationModule': {'nctId': 'NCT06905067', 'acronym': 'DENTMIN', 'briefTitle': 'Assessment of Oral Health in Minors Incarcerated at Fleury Merogis: Retrospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Sud Francilien'}, 'officialTitle': 'Assessment of Oral Health in Minors Incarcerated at Fleury Merogis: Retrospective Observational Study', 'orgStudyIdInfo': {'id': '2025/0007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Minors incarcerated in fleury-Merogis prison', 'description': 'male minors incarcerated in fleury merogis prison for a period between June and December 2024.', 'interventionNames': ['Other: questionnaire and dental clinical examination']}], 'interventions': [{'name': 'questionnaire and dental clinical examination', 'type': 'OTHER', 'description': 'Assessment of the DMFT index', 'armGroupLabels': ['Minors incarcerated in fleury-Merogis prison']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91106', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}], 'overallOfficials': [{'name': 'Dominique ORPHELIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Sud Francilien'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Sud Francilien', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}