Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-25 @ 3:04 PM
Study NCT ID:
NCT01106768
Status:
UNKNOWN
Last Update Posted:
2012-07-02
First Post:
2010-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Oral Needs of Children With Disorder Attention Deficit/Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-28', 'studyFirstSubmitDate': '2010-04-09', 'studyFirstSubmitQcDate': '2010-04-19', 'lastUpdatePostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cod and CAOD index for caries,PI and GI indices for periodontal disease, dysfunction and malocclusion classification by WHO and Analysis cephalometric', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': "Measurement of anxiety through the CFSS-DS scale (Dental subscale of Children's Fear Survey Schedule, Schedule 1)", 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['oral health needs', 'children', 'attention deficit disorder with or without hyperactivity'], 'conditions': ['Attention Deficit Disorder With Hyperactivity']}, 'descriptionModule': {'briefSummary': 'There is little accurate data in the literature at present on oral problems of hyperactive children, especially regarding care needs that would justify an assumption oral specific. The purpose of this study is therefore to have accurate data regarding the risk of caries, other oral diseases like periodontal disease, trauma, and assess the needs dental care and problems in cooperation for dental care in a population of children and adolescents with hyperactivity disorder with attention deficit. Finally, it has recently been described as the sleep disordered breathing was not uncommon in disorder attention deficit/hyperactivity disorder, whether snoring and/or apnea. But it is now accepted that some features of facial morphology favoring pharyngeal congestion occur in individuals with obstructive sleep apnea (hyperdivergent typology with increased anterior facial height and decreased posterior facial height, becoming the facial retrognathia, pharyngeal congestion, elongation and thickening of the soft palate, low position of the hyoid bone). A cephalometric analysis of craniofacial architecture and relationships with the soft tissue surrounding skeletal structures will detect if any of these specific characteristics that could promote sleep disordered breathing are found in disorder attention deficit/hyperactivity disorder prevalence with a particular.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children with attention deficit disorder with or without hyperactivity', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Consent signed by parents before the examination\n* With of a social security scheme\n* Age greater than or equal to 5 years and less than 15 years, Children with a diagnosis of attention deficit / hyperactivity confirmed or made by a physician specialists co-investigators of the study, diagnosis defined according to precise criteria for a disorder attention deficit/hyperactivity disorder as specified in DSM-IV with a normal IQ, ie higher than 80, and without other neurological or psychiatric\n* Child consultant in a hospital or doctors' offices\n\nExclusion Criteria:\n\n* Refusal of consent of the parents\n* No affiliation to a social security scheme\n* Age below 5 years or more than 15 years\n* Diagnosis of a disorder attention deficit/hyperactivity disorder not confirmed by a physician , IQ \\<80, Pathology associated neurological or psychiatric"}, 'identificationModule': {'nctId': 'NCT01106768', 'briefTitle': 'Evaluation of Oral Needs of Children With Disorder Attention Deficit/Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Evaluation of Oral Needs of Children With Disorder Attention Deficit/Hyperactivity Disorder', 'orgStudyIdInfo': {'id': '2008-A00616-49'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'test cohort', 'description': 'Evaluation of oral health needs of children with attention deficit disorder with or without hyperactivity'}, {'label': 'not disorder cohort', 'description': 'children without attention deficit disorder'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'MANIERE Marie-Cécile, MD', 'role': 'CONTACT', 'email': 'Maniere.Marie-Cecile@chru-strasbourg.fr', 'phone': '33390243887'}, {'name': 'GARRET Annelyse, MD', 'role': 'CONTACT', 'email': 'annelyse.garret-bernardin@chru-strasbourg.fr', 'phone': '3390243887'}, {'name': 'FINCK Sonja, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'DE SAINT-MARTIN Anne, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'GARRET AnneLyse, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'BACON William, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'GRAS-VINCENDON Agnès, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "CHRU ,Hopital Civil, Département d'Odontologie Pédiatrique Service de Consultations et de Traitements Dentaires", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'MANIERE Marie-Cécile, MD', 'role': 'CONTACT', 'email': 'Maniere.Marie-Cecile@chru-strasbourg.fr', 'phone': '33390243887'}], 'overallOfficials': [{'name': 'MANIERE Marie-Cécile, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'not affiliated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}