Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04040920
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2019-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ozone Application Before 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': 'D010895', 'term': 'Pit and Fissure Sealants'}], 'ancestors': [{'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Splith mouth design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 67}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2019-07-30', 'studyFirstSubmitQcDate': '2019-07-30', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sealants failure', 'timeFrame': '12 months after sealant', 'description': 'Frequency of sealed failure defined as presence of to one or more of these outcomes: Marginal fissure; Sealant fracture; Decay; Marginal pigmentations; Sealant detachment Evaluation of the relative frequency of the different causes of failure'}], 'secondaryOutcomes': [{'measure': 'Sealants failure', 'timeFrame': '6 months after sealant', 'description': 'Frequency of sealed failure defined as presence of to one or more of these outcomes: Marginal fissure; Sealant fracture; Decay; Marginal pigmentations; Sealant detachment Evaluation of the relative frequency of the different causes of failure'}, {'measure': 'Sealants failure', 'timeFrame': '24 months after sealant', 'description': 'Frequency of sealed failure defined as presence of to one or more of these outcomes: Marginal fissure; Sealant fracture; Decay; Marginal pigmentations; Sealant detachment Evaluation of the relative frequency of the different causes of failure'}, {'measure': 'Secondary decay in failed sealants', 'timeFrame': '6 months after sealant', 'description': 'Frequency of secondary decay in teeth with failed sealants'}, {'measure': 'Secondary decay in failed sealants', 'timeFrame': '12 months after sealant', 'description': 'Frequency of secondary decay in teeth with failed sealants'}, {'measure': 'Secondary decay in failed sealants', 'timeFrame': '24 months after sealant', 'description': 'Frequency of secondary decay in teeth with failed sealants'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ozone', 'Pits and fissures sealants', 'Prevention'], 'conditions': ['Caries,Dental']}, 'descriptionModule': {'briefSummary': 'Decay is a multifactorial infective degenerative disease of hard dental tissues, caused by Streptococcus mutans and Lactobacillus forming the bacterial biofilm of teeth surfaces. Decays generally evolve in fissures and pits of secondary molars. Pits and fissure sealants prevent decays if performed in two years from eruption. Ozone has bactericidal effect and remineralizing capacity on enamel.\n\nThe aim of this study is to assess the effectiveness of ozone application before sealants in increasing their duration in time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first or second secondary molars to be sealed\n* possibility to isolate with rubber dam both the teeth involved\n* no clear signs of pigmentations\n* good general health\n\nExclusion Criteria:\n\n* latex allergy\n* epilepsy or other severe neurological pathologies\n* psychiatric disease\n* excessive sensibility to electrical current\n* severe asthma\n* enamel disorders, such as amelogenesis imperfect, white spots, fluorosis or Molar Incisors Hypomineralization'}, 'identificationModule': {'nctId': 'NCT04040920', 'briefTitle': 'Ozone Application Before Fissure Sealants', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Burlo Garofolo'}, 'officialTitle': 'The Effect of Ozone Application Before Fissure Sealants: a Split Mouth Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RC 02/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ozone therapy', 'description': 'Ozone application before pits and fissure sealants', 'interventionNames': ['Device: Ozone', 'Other: Pits and fissure sealants']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pits and fissure sealants', 'interventionNames': ['Other: Pits and fissure sealants']}], 'interventions': [{'name': 'Ozone', 'type': 'DEVICE', 'description': 'One minute of pretreatment with ozone by using the OzoneDTA device', 'armGroupLabels': ['Ozone therapy']}, {'name': 'Pits and fissure sealants', 'type': 'OTHER', 'description': "cleansing of the occlusal surfaces with a nylon brush and polishing toothpaste; surface etching with 36% orthophosphoric acid for 30'', surface cleaning and drying for 30 '', application of the sealing material, polymerization for 60'';", 'armGroupLabels': ['Ozone therapy', 'Pits and fissure sealants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34137', 'city': 'Trieste', 'state': 'Trieste', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Milena Cadenaro', 'role': 'CONTACT', 'email': 'milena.cadenaro@burlo.trieste.it'}], 'facility': 'Institute for Maternal and Child Health - IRCCS Burlo Garofolo-', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}], 'centralContacts': [{'name': 'Milena Cadenaro, DDS,MSc,PhD', 'role': 'CONTACT', 'email': 'milena.cadenaro@burlo.trieste.it', 'phone': '+390403785358'}, {'name': 'Chiara Navarra, DDS,MSc,PhD', 'role': 'CONTACT', 'email': 'chiara.navarra@burlo.trieste.it', 'phone': '+390403785358'}], 'overallOfficials': [{'name': 'Milena Cadenaro, DDS,MSc,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRCCS Burlo Garofolo'}, {'name': 'Maddalena Chermetz, DDS,MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Burlo Garofolo'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After publication of data on peer reviewed journals', 'ipdSharing': 'YES', 'description': 'Data collected during the study will be available from the Study Director on reasonable request after evaluation of a protocol approved by an Ethical Committee', 'accessCriteria': 'Data collected during the study will be available from the Study Director on reasonable request after evaluation of a protocol approved by an Ethical Committee'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Burlo Garofolo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}