Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-05 @ 10:24 AM
Study NCT ID:
NCT04991168
Status:
UNKNOWN
Last Update Posted:
2021-11-02
First Post:
2021-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Oral Health and Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-01', 'studyFirstSubmitDate': '2021-07-27', 'studyFirstSubmitQcDate': '2021-07-27', 'lastUpdatePostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral health knowledge and practice questionnaire score.', 'timeFrame': '1 day', 'description': 'Oral health knowledge and practice questionnaire score.'}, {'measure': 'Number of missing and decayed teeth on the oral examination and clinical signs in diabetology.', 'timeFrame': '1 day', 'description': 'Number of missing and decayed teeth on the oral examination and clinical signs in diabetology.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral hygiene', 'Public Health', 'Patients coming to the CHU Lapeyronie for consultation or those being hospitalised there', 'Prevention', 'Telemedicine'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the state of knowledge and practices in oral health of diabetic patients through the use of two questionnaires. It is also to analyse the link between the oral health status and the profile of diabetic patient, by carrying out an oral assessment for voluntary patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic patients over 18 coming to the CHU Lapeyronie', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- All diabetic patients over 18 coming to the CHU Lapeyronie\n\nExclusion criteria:\n\n-Non diabetic patients, diabetic patients under 18'}, 'identificationModule': {'nctId': 'NCT04991168', 'briefTitle': 'Relationship Between Oral Health and Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Oral Health and Diabetes: Relationship Between Knowledge, Practices and Oral Health Status in Patients Followed in the Diabetes Department at the Montpellier University Hospital.', 'orgStudyIdInfo': {'id': 'RECHMPL21_0504'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic patients over 18 from the CHU Lapeyronie', 'description': 'Diabetic patients over 18 from the CHU Lapeyronie', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Two questionnaires used to assess the state of knowledge and practices in oral health. An oral assessment will be carried out for voluntary patients.', 'armGroupLabels': ['Diabetic patients over 18 from the CHU Lapeyronie']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Camille INQUIMBERT, Phd', 'role': 'CONTACT', 'email': 'camille.inquimbert@gmail.com', 'phone': '666957674', 'phoneExt': '33'}, {'name': 'Nicolas GIRAUDEAU, PhD', 'role': 'CONTACT', 'email': 'nicolas.giraudeau@umontpellier.fr', 'phone': '616301126', 'phoneExt': '33'}], 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Camille INQUIMBERT, PhD', 'role': 'CONTACT', 'email': 'camille.inquimbert@gmail.com', 'phone': '666957674', 'phoneExt': '33'}, {'name': 'Nicolas GIRAUDEAU, PhD', 'role': 'CONTACT', 'email': 'nicolas.giraudeau@umontpellier.fr', 'phone': '616301126', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Camille INQUIMBERT, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}, {'name': 'Amir MEZIANE, resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH MONTPELLIER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}