Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-04 @ 11:11 PM
Study NCT ID:
NCT03235960
Status:
UNKNOWN
Last Update Posted:
2017-08-01
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Glass-ionomer Fissure Sealants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-02-06', 'releaseDate': '2018-08-27'}], 'estimatedResultsFirstSubmitDate': '2018-08-27'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-31', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-31', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'absence of caries', 'timeFrame': 'every 12 months during 13 years', 'description': 'absence of caries on sealed tooth surfaces'}, {'measure': 'retention of sealant', 'timeFrame': 'every 12 months during 13 years', 'description': 'complete or partial retention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Fissure Sealant', 'Glass-ionomer Cement', 'Permanent Molar']}, 'descriptionModule': {'briefSummary': 'Despite numerous techniques for enamel protection, occlusal caries still remains a problem. Sealing pits and fissures is considered to be an effective way of preventing caries development. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.', 'detailedDescription': 'Despite numerous techniques for enamel protection, such as topical fluorides, calcium phosphate-based remineralization systems, xylitol, etc., occlusal caries still remains a problem. A carious lesion occurs in pits and fissures of occlusal surfaces primarily due to their specific anatomy, which is considered to be an ideal site for the retention of bacteria and food remnants rendering mechanical means of debridement inaccessible. Sealing pits and fissures is considered to be an effective way of preventing caries development. Today, there is a wide spectrum of available sealing materials. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. During last decades, glass-ionomer cements of different physical and chemical properties were used for pits and fissure sealing which probably contributed to variances in their clinical efficacy. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy children who appeared for a regular dental examination', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least one recently erupted permanent molar with sound pits and fissures\n* healthy patients\n* possibility to perform a dental treatment\n* willing to participate in the study\n\nExclusion Criteria:\n\n* teeth with an obvious cavity, with a restoration or a sealant completely or partially presented in the fissure system\n* medically compromised patients\n* non cooperative patients\n* not willing to participate in the study'}, 'identificationModule': {'nctId': 'NCT03235960', 'briefTitle': 'Efficacy of Glass-ionomer Fissure Sealants', 'organization': {'class': 'OTHER', 'fullName': 'Association of Paediatric and Preventive Dentists of Serbia'}, 'officialTitle': 'Clinical Efficacy of Glass-ionomer Fissure Sealants', 'orgStudyIdInfo': {'id': '001-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'glass-ionomer fissure sealant', 'type': 'DEVICE', 'description': "The encapsulated glass-ionomer cement for fissure protection was applied onto the selected permanent molar according to the manufacturer's instruction"}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belgrade', 'country': 'Serbia', 'facility': 'University of Belgrade, School of Dental Medicine', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'overallOfficials': [{'name': 'Dejan Markovic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Belgrade, School of Dental Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association of Paediatric and Preventive Dentists of Serbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Dejan Markovic', 'investigatorAffiliation': 'Association of Paediatric and Preventive Dentists of Serbia'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-08-27', 'type': 'RELEASE'}, {'date': '2019-02-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dejan Markovic, professor, Association of Paediatric and Preventive Dentists of Serbia'}}}}