Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-01 @ 12:22 AM
Study NCT ID:
NCT04679558
Status:
COMPLETED
Last Update Posted:
2021-08-13
First Post:
2020-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibacterial Effect of Chlorhexidine Added to the Preventive Protocol in Adolescent Special Needs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010150', 'term': 'Paint'}], 'ancestors': [{'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-11', 'studyFirstSubmitDate': '2020-12-14', 'studyFirstSubmitQcDate': '2020-12-19', 'lastUpdatePostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Streptococcus mutans count', 'timeFrame': '1 year', 'description': 'Antibacterial effect of chlorhexidine on streptococcus mutans count'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caries']}, 'descriptionModule': {'briefSummary': "This study ia conducted to know the antibacterial effect of chlorhexidine on the mouth flora speciallly in adolescent special needs who can't hold the tooth brush properly", 'detailedDescription': "This study ia conducted to know the antibacterial effect of chlorhexidine on the mouth flora speciallly in adolescent special needs who can't hold the tooth brush properly cause those have alot of problems concerning the accumulagio. Of plaque and so increased bacteria"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of disability like special needs autism and down syndrome\n\nExclusion Criteria:\n\n* age below 13'}, 'identificationModule': {'nctId': 'NCT04679558', 'briefTitle': 'Antibacterial Effect of Chlorhexidine Added to the Preventive Protocol in Adolescent Special Needs', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Antibacterial Effect of Chlorhexidine Added to the Preventive Protocol in Adolescent Special Needs', 'orgStudyIdInfo': {'id': '7all'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator', 'description': 'Preventive protocol', 'interventionNames': ['Behavioral: Preventive protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Adding chlorhexidine to the preventive protocol', 'interventionNames': ['Drug: Chlorhexidine varnish added to the preventive protocol']}], 'interventions': [{'name': 'Chlorhexidine varnish added to the preventive protocol', 'type': 'DRUG', 'otherNames': ['Varnish'], 'description': 'Antibacterial agent varnish added to the preventive protocol', 'armGroupLabels': ['Intervention']}, {'name': 'Preventive protocol', 'type': 'BEHAVIORAL', 'otherNames': ['Caries preventive protocol'], 'description': 'Preventive protocol', 'armGroupLabels': ['Comparator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'School', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Katreen Fouad', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resident'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '10 months', 'ipdSharing': 'YES', 'description': 'Journal', 'accessCriteria': 'Journal article'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Katreen Tawfik', 'investigatorAffiliation': 'Cairo University'}}}}