Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-02-28 @ 10:21 PM
Study NCT ID:
NCT02795728
Status:
COMPLETED
Last Update Posted:
2016-06-10
First Post:
2016-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fuji Type VII Sealant Versus Resin Based Sealant. A Clinical Trial
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-09', 'studyFirstSubmitDate': '2016-05-28', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention of the sealant', 'timeFrame': 'Baseline to 1 year', 'description': 'Retention of the sealants will be assessed by using the Simensons criteria'}], 'secondaryOutcomes': [{'measure': 'Caries incidence', 'timeFrame': 'Baseline to 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'Purpose: To evaluate the retention and caries preventive effect of the glass-ionomer fissure sealants and resin-based fissure sealant. Materials and Methods: Using a split mouth design ,a double blind randomized controlled clinical trial was conducted to compare the retention and the caries preventive effect of light cure resin base sealant (3M ESPE) and Glass ionomer sealant (FUJI). The study comprised of 120 government school children of 7-9 years age group. The glass-ionomer sealant and resin-based sealant were applied randomly on either side of the first mandibular permanent molars. They were recalled for assessment of sealant retention at intervals of 3, 6 and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with a fully erupted contra lateral permanent mandibular first molars with well-defined deep pits and fissures and molars free of mucosal tissue are included in the study.\n\nExclusion Criteria:\n\n* Molars with developmental anomalies, hypoplastic teeth were promptly excluded'}, 'identificationModule': {'nctId': 'NCT02795728', 'briefTitle': 'Fuji Type VII Sealant Versus Resin Based Sealant. A Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Kamineni Institute of Dental Sciences'}, 'officialTitle': 'Fuji Type VII Sealants Versus Resin Based Sealants. A Clinical Trial', 'orgStudyIdInfo': {'id': 'SSCDS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'Fuji type VII is a GIC based sealant with an additional property of high fluoride release', 'interventionNames': ['Other: Application of the GIC based sealant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Resin based sealant', 'description': 'Helioseal F is a resin based sealant', 'interventionNames': ['Other: Resin based sealant']}], 'interventions': [{'name': 'Application of the GIC based sealant', 'type': 'OTHER', 'description': "Application of the GIC based sealant was carried out according to the manufacturer's instructions.", 'armGroupLabels': ['Experimental arm']}, {'name': 'Resin based sealant', 'type': 'OTHER', 'description': 'Application of the resin based sealant on the occlusal surfaces was carried out as per the manufacturer s recommendations.', 'armGroupLabels': ['Resin based sealant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '501101', 'city': 'Vikārābād', 'state': 'Telangana', 'country': 'India', 'facility': 'Sri Sai college of Dental surgery', 'geoPoint': {'lat': 17.3381, 'lon': 77.90441}}], 'overallOfficials': [{'name': 'Prathibha Rao, MDS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sri Sai college of Dental surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kamineni Institute of Dental Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr. Praveen B.H', 'investigatorAffiliation': 'Kamineni Institute of Dental Sciences'}}}}