Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-02-12 @ 4:32 AM
Study NCT ID:
NCT02594020
Status:
COMPLETED
Last Update Posted:
2016-04-25
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Different Methods of Enamel Preparation Before Pit and Fissure Sealants
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': 'D020906', 'term': 'Air Abrasion, Dental'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-22', 'studyFirstSubmitDate': '2013-06-04', 'studyFirstSubmitQcDate': '2015-10-30', 'lastUpdatePostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'observation of quality of treatment', 'timeFrame': '2 years', 'description': 'Compare enamel preparation techniques of air abrasion and sound abrasion technique enameloplasty (pits and fissures extended to the dental bur) the more conventionally used to identify the most effective as using endpoint retention of material sealing of pits and fissures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['suspected caries', 'initial enamel lesions'], 'conditions': ['Enamel Lesions', 'Dental Caries']}, 'descriptionModule': {'briefSummary': 'This study concerns the prevention of dental caries by sealing pits and fissures of permanent molars with a photopolymerizable resin. It must compare these three techniques Microdentisty (air abrasion, abrasion and sound using small cutters) usually used to prepare micro cavities in the enamel and / or the outer third of the dentin. These three commonly used techniques have never been compared by retaining as endpoint retention of sealant. These techniques are painless and do not require local anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Affiliated with the Social Security\n* Attendance at inspections\n* Subject to high individual risk of caries\n* Subjects with at least two pairs of molars and contralateral counterparts with the initial lesions of enamel (pits and fissures colored) or suspected of dentine caries (not highlighted by two clinical and radiographic examination usual)\n\nExclusion Criteria:\n\n* Molar inaccessible, closed, sealed, or decayed (reaching the dentine'}, 'identificationModule': {'nctId': 'NCT02594020', 'briefTitle': 'Comparison of Different Methods of Enamel Preparation Before Pit and Fissure Sealants', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'orgStudyIdInfo': {'id': '08-PP-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'dental bur versus air abrasion', 'description': '1 tooth prepared with air abrasion versus one prepared tooth with dental bur', 'interventionNames': ['Procedure: air abrasion', 'Procedure: dental bur']}, {'type': 'OTHER', 'label': 'sono abrasion versus dental bur', 'description': '1 tooth prepared with sono abrasion ans 1 tooth prepared with dental bur', 'interventionNames': ['Procedure: sono abrasion', 'Procedure: dental bur']}, {'type': 'OTHER', 'label': 'air abrasion versus sono abrasion', 'description': '1 tooth prepared with air abrasion versus 1 tooth prepared with sono abrasion', 'interventionNames': ['Procedure: air abrasion', 'Procedure: sono abrasion']}], 'interventions': [{'name': 'air abrasion', 'type': 'PROCEDURE', 'description': 'already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin', 'armGroupLabels': ['air abrasion versus sono abrasion', 'dental bur versus air abrasion']}, {'name': 'sono abrasion', 'type': 'PROCEDURE', 'description': 'already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin', 'armGroupLabels': ['air abrasion versus sono abrasion', 'sono abrasion versus dental bur']}, {'name': 'dental bur', 'type': 'PROCEDURE', 'description': 'already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin', 'armGroupLabels': ['dental bur versus air abrasion', 'sono abrasion versus dental bur']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75000', 'city': 'Paris', 'country': 'France', 'facility': 'APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}