Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-22 @ 11:39 AM
Study NCT ID:
NCT01438866
Status:
COMPLETED
Last Update Posted:
2014-03-18
First Post:
2011-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Fissure Sealants on Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-06-02', 'releaseDate': '2015-05-18'}, {'resetDate': '2015-08-11', 'releaseDate': '2015-07-15'}, {'resetDate': '2016-11-10', 'releaseDate': '2016-09-23'}, {'resetDate': '2018-03-26', 'releaseDate': '2017-08-24'}], 'estimatedResultsFirstSubmitDate': '2015-05-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010895', 'term': 'Pit and Fissure Sealants'}], 'ancestors': [{'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-16', 'studyFirstSubmitDate': '2011-09-18', 'studyFirstSubmitQcDate': '2011-09-21', 'lastUpdatePostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of healthy occlusal tooth surfaces of primary molars', 'timeFrame': 'up to 1 year', 'description': 'Outcome will be measured by a clinical examination (dental caries status/ICDAS) one year after the fissure sealants and fluoride varnish have been applied. When a child has intact occlusal surfaces on primary molars in the baseline examination, s/he will get a fissure sealant on the other side of the mouth and fluoride varnish on the other side.'}], 'secondaryOutcomes': [{'measure': 'Number of healthy occlusal tooth surfaces after application of fissure sealants versus fluoride varnish', 'timeFrame': 'up to 1 year', 'description': 'Outcome will be measured by a clinical examination (dental caries status/ICDAS)one year after the fissure sealants and fluoride varnish have been applied. The effectiveness of these two preventive treatment will be compared, i.e. how many occlusal surfaces of primary molars stayed caries free with the sealant application vs. fluoride varnish application.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dental caries', 'Fissure sealant', 'Fluoride varnish', 'Primary molar'], 'conditions': ['Dental Caries']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.hsc.edu.kw/fod/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Sealants have been shown to be the most effective caries preventive measure in permanent dentition. Sealants of the primary molars soon after they erupt would reduce the total caries experience of the primary teeth of the children and could possibly also postpone the caries process in the permanent dentition.\n\nThe aim of this study is to measure the caries preventive effect of sealants in primary molars. The specific objectives are: 1) to compare the number of new caries experience teeth and surfaces among the intervention group of 4-years old pre-school children during the 1 year follow-up period, 2) to compare the preventive effect of sealants with fluoride varnish on the caries experience on the occlusal surfaces of the primary molars and on the total caries experience of all the primary and permanent teeth, 3) to test the feasibility of the sealant program in one kindergarten in Kuwait city.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '52 Months', 'minimumAge': '42 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* positive written informed consent received from parents\n\nExclusion Criteria:\n\n* if caries lesions in primary molars are so extensive that restorative treatment is needed'}, 'identificationModule': {'nctId': 'NCT01438866', 'briefTitle': 'Use of Fissure Sealants on Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Kuwait University'}, 'officialTitle': 'The Effectiveness of Sealants in Prevention of Occlusal Caries on Primary Molars', 'orgStudyIdInfo': {'id': 'DD03/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preventing occlusal caries', 'description': 'Comparing preventing effect of fissure sealants vs. fluoride varnish', 'interventionNames': ['Other: Fissure sealant', 'Other: Fissure sealants and fluoride varnish']}], 'interventions': [{'name': 'Fissure sealant', 'type': 'OTHER', 'otherNames': ['Brand name: Clinpro™ Sealant', 'Produced by: 3M ESPE', 'www.3MESPE.com/PrventiveCare', 'Brand name: DuraShield® 5% Sodium Fluoride Varnish', 'Produced by: Sultan Dental Products', 'www.sultandental.com'], 'description': 'Preventing dental caries in primary molars by applying fissure sealants and fluoride varnish, and comparing caries preventive effect of sealants with fluoride varnish.', 'armGroupLabels': ['Preventing occlusal caries']}, {'name': 'Fissure sealants and fluoride varnish', 'type': 'OTHER', 'otherNames': ['ClinproTM (3M ESPE)', 'DuraShield® (Sultan Healthcare)'], 'description': 'Comparing preventive effect of fissure sealants and fluoride varnish on occlusal surfaces of primary molars', 'armGroupLabels': ['Preventing occlusal caries']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuwait City', 'state': 'Hawally', 'country': 'Kuwait', 'facility': 'Kindergarten', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}], 'overallOfficials': [{'name': 'Sisko L Honkala, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Kuwait University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuwait University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sisko Honkala', 'investigatorAffiliation': 'Kuwait University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-05-18', 'type': 'RELEASE'}, {'date': '2015-06-02', 'type': 'RESET'}, {'date': '2015-07-15', 'type': 'RELEASE'}, {'date': '2015-08-11', 'type': 'RESET'}, {'date': '2016-09-23', 'type': 'RELEASE'}, {'date': '2016-11-10', 'type': 'RESET'}, {'date': '2017-08-24', 'type': 'RELEASE'}, {'date': '2018-03-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sisko Honkala, Associate Professor, Kuwait University'}}}}