Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2026-01-04 @ 8:59 AM
Study NCT ID:
NCT02512367
Status:
TERMINATED
Last Update Posted:
2021-05-20
First Post:
2015-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy of a Global Dental Health Promotion Program on Dental Hygiene in Patients With Schizophrenia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'whyStopped': 'lack of inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2015-07-29', 'studyFirstSubmitQcDate': '2015-07-29', 'lastUpdatePostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with a Community Peridontal Index (CPI) ≥3', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '37444782', 'type': 'DERIVED', 'citation': 'Denis F, Rat C, Cros L, Bertaud V, El-Hage W, Jonval L, Soudry-Faure A. Effectiveness of a Therapeutic Educational Oral Health Program for Persons with Schizophrenia: A Cluster Randomized Controlled Trial and Qualitative Approach. Healthcare (Basel). 2023 Jul 5;11(13):1947. doi: 10.3390/healthcare11131947.'}, {'pmid': '27757142', 'type': 'DERIVED', 'citation': 'Denis F, Millot I, Abello N, Carpentier M, Peteuil A, Soudry-Faure A. Study protocol: a cluster randomized controlled trial to assess the effectiveness of a therapeutic educational program in oral health for persons with schizophrenia. Int J Ment Health Syst. 2016 Oct 5;10:65. doi: 10.1186/s13033-016-0096-0. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'There are few disease prevention programs or programs to manage somatic disorders in a psychiatric context. The aim of this study is to evaluate the impact in the medium term of a global program to promote dental health on buccodental hygiene in patients with schizophrenia and the ability of these patients to follow the intervention.\n\nThis is an interventional trial, randomized in clusters. The participating establishments will be randomized to the "intervention" group (promotion program) or the "control" group (surveillance).\n\nFor each patient, the study will last 12 months altogether and will include an initial evaluation of dental health, a 6-month education program for dental care (for patients in the "intervention" group) and a follow-up at 6 and 12 months after the start of the study. The follow-up will evaluate dental health and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM V)\n* Managed at a specialized establishment\n* Older than 18 years.\n* who have provided written informed consent to take part in the study\n\nExclusion Criteria:\n\n* Fully hospitalized patients\n* Patients who are unstable from a psychiatric poit of view or who suffer from delirium.\n* Subjects with less than one incisor, canine, premolar and molar on each hemi-arch\n* Patients with a risk of infectious endocarditis or a major risk of superinfection\n* Patients on long-term treatment with antibiotics (Impact of antibiotherapy on oral flora)\n* Patients treated with chemotherapy\n* Pregnant or breastfeeding women\n* Patients without National Health Insurance cover.\n* Poor written and/or oral comprehension of the French language'}, 'identificationModule': {'nctId': 'NCT02512367', 'acronym': 'EBENE', 'briefTitle': 'Evaluate the Efficacy of a Global Dental Health Promotion Program on Dental Hygiene in Patients With Schizophrenia.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Efficacy of a Dental Health Promotion Program in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'DENIS PHRC I 2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Other: Dental care education program']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Surveillance', 'interventionNames': ['Other: Surveillance']}], 'interventions': [{'name': 'Dental care education program', 'type': 'OTHER', 'description': 'Dental care education program', 'armGroupLabels': ['Intervention']}, {'name': 'Surveillance', 'type': 'OTHER', 'description': 'Surveillance', 'armGroupLabels': ['Surveillance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '69678', 'city': 'Bron', 'country': 'France', 'facility': 'CH Le Vinatier', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '67173', 'city': 'Brumath', 'country': 'France', 'facility': 'Chs Epsan', 'geoPoint': {'lat': 48.73398, 'lon': 7.71095}}, {'zip': '73011', 'city': 'Chambéry', 'country': 'France', 'facility': 'CHS de la Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'CH La Chartreuse', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de DIJON', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '39108', 'city': 'Dole', 'country': 'France', 'facility': 'CHS du Jura', 'geoPoint': {'lat': 47.09225, 'lon': 5.48966}}, {'zip': '87025', 'city': 'Limoges', 'country': 'France', 'facility': 'CH Esquirol', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '57073', 'city': 'Metz', 'country': 'France', 'facility': 'CH de Jury', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '25220', 'city': 'Novillars', 'country': 'France', 'facility': 'CH de Novillars', 'geoPoint': {'lat': 47.28465, 'lon': 6.12878}}, {'zip': '70160', 'city': 'Saint-Rémy', 'country': 'France', 'facility': 'CH de Saint-Rémy et Nord Franche Comté', 'geoPoint': {'lat': 46.76334, 'lon': 4.83928}}, {'zip': '21140', 'city': 'Semur-en-Auxois', 'country': 'France', 'facility': 'CH de Semur en Auxois', 'geoPoint': {'lat': 47.48333, 'lon': 4.33333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}