Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT01829334
Status:
COMPLETED
Last Update Posted:
2013-04-11
First Post:
2013-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C094502', 'term': 'Bifluorid 12'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 329}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-08', 'studyFirstSubmitDate': '2013-04-08', 'studyFirstSubmitQcDate': '2013-04-08', 'lastUpdatePostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dental caries', 'timeFrame': '3 years', 'description': 'development of carious cavity after 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dental caries'], 'conditions': ['Dental Caries']}, 'referencesModule': {'references': [{'pmid': '24886444', 'type': 'DERIVED', 'citation': 'Liu BY, Xiao Y, Chu CH, Lo EC. Glass ionomer ART sealant and fluoride-releasing resin sealant in fissure caries prevention--results from a randomized clinical trial. BMC Oral Health. 2014 May 19;14:54. doi: 10.1186/1472-6831-14-54.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this proposed study is to investigate the cost-effectiveness of four methods in preventing fissure caries in permanent teeth, which is the most prevalent dental disease in primary school children in China.\n\nThe four caries prevention methods are: resin fissure sealant, atraumatic restorative treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF) solution.\n\nThe specific study objectives are:\n\n1. to describe longitudinally the clinical outcomes of using the above four methods to prevent dental caries in the pits and fissures of permanent first molars in school children,\n2. to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in China, and\n3. to compare the cost-effectiveness of the above four caries prevention methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* school children in good general health\n* has at least one pair of sound permanent first molars with deep occlusal fissures or fissures with signs of early caries\n\nExclusion Criteria:\n\n* children with major systemic disease or on long-term medication\n* children not cooperative and refuse dental treatments'}, 'identificationModule': {'nctId': 'NCT01829334', 'briefTitle': 'Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth', 'orgStudyIdInfo': {'id': 'UW 06-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Resin dental sealant', 'description': 'Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement', 'interventionNames': ['Other: Resin dental sealant']}, {'type': 'EXPERIMENTAL', 'label': 'ART dental sealant', 'description': 'ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement', 'interventionNames': ['Other: ART dental sealant']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium fluoride varnish', 'description': 'Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months', 'interventionNames': ['Other: Sodium fluoride varnish']}, {'type': 'EXPERIMENTAL', 'label': 'Silver fluoride solution', 'description': 'Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months', 'interventionNames': ['Other: Silver fluoride solution']}], 'interventions': [{'name': 'ART dental sealant', 'type': 'OTHER', 'description': 'ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement', 'armGroupLabels': ['ART dental sealant']}, {'name': 'Resin dental sealant', 'type': 'OTHER', 'description': 'Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement', 'armGroupLabels': ['Resin dental sealant']}, {'name': 'Sodium fluoride varnish', 'type': 'OTHER', 'description': 'Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months', 'armGroupLabels': ['Sodium fluoride varnish']}, {'name': 'Silver fluoride solution', 'type': 'OTHER', 'description': 'Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months', 'armGroupLabels': ['Silver fluoride solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenzhen', 'country': 'China', 'facility': 'Primary schools', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'overallOfficials': [{'name': 'Edward CM Lo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'LO, Edward Chin Man', 'investigatorAffiliation': 'The University of Hong Kong'}}}}