Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT00966394
Status:
COMPLETED
Last Update Posted:
2010-05-26
First Post:
2009-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salivary Bacteria and Oral Health Status in Children With ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D014987', 'term': 'Xerostomia'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-25', 'studyFirstSubmitDate': '2009-08-25', 'studyFirstSubmitQcDate': '2009-08-25', 'lastUpdatePostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADHD, saliva, caries'], 'conditions': ['Attention Deficit Hyperactivity Disorders', 'Caries, Dental', 'Xerostomia']}, 'descriptionModule': {'briefSummary': 'Attention deficit and hyperactivity (ADHD) affect 6% of school-aged children. Few studies reported higher prevalence of caries and restorations among children with ADHD. Methylphenidate is the drug of choice to treat ADHD. according to the medical literature methylphenidate can cause xerostomia.\n\nOur study will investigate saliva parameters (such as quantity, bacteria in saliva, buffer capacity), oral hygiene and diet habits and their influence on caries among children with ADHD and among healthy children.\n\nOur hypothesis is:\n\n* Children with ADHD will have more caries.\n* Children with ADHD will have more detrimental oral hygiene and diet habits.\n* There will be a difference in the saliva parameters between children with ADHD and healthy children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with ADHD, treated by medications or not, treated in the neurologic clinic at Hadassah.\n\nThe control are healthy children visiting the pediatric dental clinic at Hadassah.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* test group- diagnosis of ADHD.\n* control group- ASA1\n\nExclusion Criteria:\n\n* control group\n* administration of medicine at the time of the check-up.'}, 'identificationModule': {'nctId': 'NCT00966394', 'acronym': 'ADHD', 'briefTitle': 'Salivary Bacteria and Oral Health Status in Children With ADHD', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Changes in Salivary Bacteria and Oral Health Status in Children With Attention Deficit Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': 'adhd-hmo-ctil'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ADHD medication', 'description': 'Children with ADHD and pharmacologic treatment'}, {'label': 'ADHD without medication', 'description': 'Children with ADHD without pharmacologic treatment'}, {'label': 'healthy', 'description': 'Healthy children ASA1'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah school of dental medicine', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Moti Moskovitz', 'oldOrganization': 'Department of Pediatric Dentistry, Hadassah School of Dental Medicine'}}}}