Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT04274569
Status:
UNKNOWN
Last Update Posted:
2020-02-18
First Post:
2019-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Three Types of Fluoride Varnish in Preventing Early Childhood Caries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-02-02', 'releaseDate': '2023-05-31'}], 'estimatedResultsFirstSubmitDate': '2023-05-31'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 570}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-17', 'studyFirstSubmitDate': '2019-11-12', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of children with new caries and new dmfs.', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'MS growth', 'timeFrame': '12 months and 24 months', 'description': 'Quantity of mutans streptococcus (MS) measured by quantitative polymerase chain reaction (qPCR)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caries', 'Fluoride vanish', 'Calcium phosphate', 'Randomised clinical trial', 'Remineralisation'], 'conditions': ['Early Childhood Caries']}, 'descriptionModule': {'briefSummary': 'This study evaluates and compares the effect of two types of calcium- and phosphate-containing fluoride varnishes to conventional fluoride varnishes in preventing early childhood caries.', 'detailedDescription': 'Fluoride vanish is the most commonly used professionally applied topical agent. Traditional fluoride vanish application has been reported to exhibit significant caries inhibiting effect in both permanent teeth and primary teeth. The greatest advantage of fluoride vanish is its ability to adhere to tooth tissues for a longer period of time that enables improved fluoride uptake. It allows continuous release of fluoride ions into enamel, dentine, plaque, and saliva.The main action of topical fluoride is to retard demineralization and promote remineralization of enamel by the uptake of calcium and phosphates from saliva. The proposed mechanism of action of topical fluoride is the formation of intraoral calcium fluoride reservoirs, which are retained on enamel and slowly released to inhibit mineral loss during demineralization.\n\nHowever, the formation of the intraoral calcium fluoride reservoirs is limited by the availability of intraoral calcium and fluoride ions. Low concentration of salivary calcium and phosphate ions leads to mineral deposition only at the surface of enamel as a result of low ion concentration gradient. Deposition of minerals at the surface of enamel alone may not improve the structural properties of the deep part of the incipient carious lesions. Hence, many manufacturers have modified fluoride vanish to include calcium and phosphate ions in an attempt to further improve efficacy of fluoride varnishes.\n\nThe in vitro remineralizing effects of calcium- and phosphate-containing fluoride vanishes are encouraging and scientifically sound, a longitudinal, high quality clinical study is needed to verify the laboratory findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy children age between 3-4 of age with unremarkable medical history and at high caries risk with at least one carious lesion (precavitated or cavitated) (Agouropoulos et al 2014). The high caries risk children are chosen because it is anticipated that they will benefit more from the topical fluoride varnish application than the low caries risk children.\n\nExclusion Criteria:\n\n* Patients who had received professional fluoride application in the past 6 months\n\n * Patients with underlying medical history or special health care needs\n * Patient who are uncooperative or refuse the treatment\n * Patient who are allergic to milk protein (as MI VarnishTM contains "casein, a milk protein)\n * Patient with contraindication for fluoride varnish e.g. hypersensitivity to colophony and/or any other constituents\n * Patient who have primary teeth with enamel hypoplasia'}, 'identificationModule': {'nctId': 'NCT04274569', 'briefTitle': 'Effect of Three Types of Fluoride Varnish in Preventing Early Childhood Caries', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Are Calcium- and Phosphate-containing Fluoride Varnishes More Effective Than Conventional Fluoride Varnish in Preventing Early Childhood Caries? A Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'GRF Project HKU17106318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium fluoride (NaF)', 'description': 'Group 1: Quarterly application of a 5% NaF varnish (Duraphat® Varnish, Colgate-Palmolive Ltd, (UK) Ltd., Guildford, Surrey, UK)', 'interventionNames': ['Other: NaF vanish']}, {'type': 'EXPERIMENTAL', 'label': 'NaF plus tricalcium phosphate (TCP )', 'description': 'Group 2: Quarterly application of 5% NaF-TCP (ClinproTM White Varnish; 3M ESPE, St Paul, MN, USA)', 'interventionNames': ['Other: NaF-TCP']}, {'type': 'EXPERIMENTAL', 'label': 'NaF plus CPP-ACP', 'description': 'Group 3: Quarterly application of a 5% NaF plus casein phosphopeptide-stabilized amorphous calcium phosphate complexes (CPP-ACP) (MI Varnish TM; GC corporation, Itabashi-Ku, Tokyo, Japan)', 'interventionNames': ['Other: NaF-CPP-ACP']}], 'interventions': [{'name': 'NaF vanish', 'type': 'OTHER', 'description': 'A disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up.', 'armGroupLabels': ['Sodium fluoride (NaF)']}, {'name': 'NaF-TCP', 'type': 'OTHER', 'description': 'A disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up.', 'armGroupLabels': ['NaF plus tricalcium phosphate (TCP )']}, {'name': 'NaF-CPP-ACP', 'type': 'OTHER', 'description': 'A disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up.', 'armGroupLabels': ['NaF plus CPP-ACP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '999077', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Grants Council, Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor in Paediatric Dentistry', 'investigatorFullName': 'Professor Cynthia Kar-Yung Yiu', 'investigatorAffiliation': 'The University of Hong Kong'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-05-31', 'type': 'RELEASE'}, {'date': '2024-02-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Professor Cynthia Kar-Yung Yiu, Clinical Professor in Paediatric Dentistry, The University of Hong Kong'}}}}