Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04854720
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2021-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization was performed by a computer-generated random sorting sequence (sealed in opaque envelopes that sequentially numbered randomly selected through).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled, three-arm parallel, single-blinded, split-mouth clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-01', 'studyFirstSubmitDate': '2021-04-18', 'studyFirstSubmitQcDate': '2021-04-18', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars.', 'timeFrame': '18 months after the clinical applications', 'description': 'The primary outcome of the study was the assessment of clinical retention rates at 18th months.'}, {'measure': 'The assessment of marginal adaptation rates of fissure sealants applied to newly erupted permanent first molars.', 'timeFrame': '18 months after the clinical applications', 'description': 'The primary outcome of the study was the assessment of marginal adaptation rates at 18th months.'}, {'measure': 'The assessment of marginal discoloration rates of fissure sealants applied to newly erupted permanent first molars.', 'timeFrame': '18 months after the clinical applications', 'description': 'The primary outcome of the study was the assessment of marginal discoloration rates at 18th months.'}, {'measure': 'The assessment of secondary caries rates of fissure sealants applied to newly erupted permanent first molars.', 'timeFrame': '18 months after the clinical applications', 'description': 'The primary outcome of the study was the assessment of secondary caries rates at 18th months.'}], 'secondaryOutcomes': [{'measure': 'The assessment of remineralization capacity using DIAGNOdent device', 'timeFrame': '18 months after the clinical applications', 'description': 'The secondary outcome of the study was the assessment of remineralization capacity using DIAGNOdent, at 18th months.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Conventional glass ionomer', 'fissure sealant', 'giomer', 'laser fluorescence', 'newly erupted teeth', 'resin modified glass ionomer'], 'conditions': ['Fissure Sealant']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the clinical retention rates, marginal adaptation, marginal discoloration and secondary caries formation of two different types of resin-modified glass ionomers (Fuji® II LC; Clinpro™ XT Varnish) and giomer-containing fissure sealant materials (Beautifil Flow) with glass ionomer-containing fissure sealant material (Fuji Triage®) used on newly erupted non-carious first permanent molars as a fissure sealant.\n\nThe study included 384 teeth belonging to 182 children, aged between 5 to 9 years old, who have two newly erupted mandibular permanent first molars.', 'detailedDescription': 'Firstly, patients were randomly allocated to three main groups: Group 1; Fuji II LC/Fuji Triage (Control) (62 patients), Group 2; Clinpro XT Varnish/Fuji Triage (Control) (60 patients), Group 3; Beautifil Flow/Fuji Triage (Control) (60 patients). After clinical applications, all samples were evaluated in terms of retention, marginal adaptation, marginal discoloration and secondary caries formation using modified USPHS criteria in 6th, 12th and 18th months. Also samples were evaluated in terms of remineralization effect using the laser fluorescence method. Evaluations on occlusal and buccal surfaces were performed separately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children who have two newly erupted non-carious mandibular permanent first molars that fissure sealant is indicated,\n* Newly erupted first permanent molars show scores of 0 (Sound tooth surface)-1(First visual change in enamel) according to ICDAS II,\n* Newly erupted first permanent molars show scores between 0-13 by using DIAGNOdent device,\n* Children who haven't any systemic disease that prevents the application,\n* Cooperative children who allowed the clinical applications.\n\nExclusion Criteria:\n\n* Teeth with proximal and initial caries,\n* Teeth with applied fissure sealant,\n* Teeth with developmental defects such as hypoplasia and restorations,\n* Non-cooperative children who don't allow the clinical applications,\n* Children and parents who denied the participation in the follow-up appointments."}, 'identificationModule': {'nctId': 'NCT04854720', 'briefTitle': 'Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Katip Celebi University'}, 'officialTitle': 'Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2018-TDU-DİŞF-0050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (Fuji II LC-Fuji Triage)', 'description': 'In Group 1, newly erupted mandibular permanent first molars were sealed with resin-modified glass ionomers containing fissure sealant material (Fuji® II LC, GC Corporation, Tokyo, Japan) (test 1). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control).', 'interventionNames': ['Device: Fuji® II LC CAPSULE', 'Device: Fuji Triage® CAPSULE']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (Clinpro XT Varnish-Fuji Triage)', 'description': 'In Group 2, newly erupted mandibular permanent first molars were sealed with resin-modified glass ionomers containing fissure sealant material (Clinpro™ XT Varnish, 3M ESPE, St. Pauls, Miniapolis, MN, USA) (test 2). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control).', 'interventionNames': ['Device: Clinpro™ XT Varnish', 'Device: Fuji Triage® CAPSULE']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 (Beautiful Flow- Fuji Triage)', 'description': 'In Group 3, newly erupted mandibular permanent first molars were sealed with Giomer containing fissure sealant material (Beautifil Flow, Shofu, Kyoto, Japan) (test 3). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control).', 'interventionNames': ['Device: Beautifil Flow', 'Device: Fuji Triage® CAPSULE']}], 'interventions': [{'name': 'Fuji® II LC CAPSULE', 'type': 'DEVICE', 'otherNames': ['Fuji® II LC CAPSULE, GC Corporation, Tokyo, Japan'], 'description': "Fuji® II LC is a resin modified glass ionomer contained, fluoride releasing and light-cured material. Since the product is tolerant to moisture and saliva, it's used for fissure sealant of newly erupted teeth.\n\nTest 1 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.The tooth surface was rinsed with water and dried. Thereafter, Fuji® II LC was applied to the pits and fissures on the tooth surface using a brush. Then, the varnish was applied and cured according to the manufacturer's instructions.", 'armGroupLabels': ['Group 1 (Fuji II LC-Fuji Triage)']}, {'name': 'Clinpro™ XT Varnish', 'type': 'DEVICE', 'otherNames': ['Clinpro™ XT Varnish, 3M ESPE, St. Pauls, Miniapolis, MN, USA'], 'description': "Clinpro™ XT Varnish is a resin modified glass ionomer containing, fluoride-releasing, light-cured varnish. Since the product is tolerant to moisture and saliva, it is used for fissure sealant of newly erupted teeth. The product can be recharged with fluoride using fluoride-containing products.\n\nTest 2 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 35% phosphoric acid was applied to all surfaces of the tooth for 15 seconds.Then the tooth surface was rinsed with water and dried. Thereafter, Clinpro™ XT Varnish was applied in compliance with the manufacturers' instructions.", 'armGroupLabels': ['Group 2 (Clinpro XT Varnish-Fuji Triage)']}, {'name': 'Beautifil Flow', 'type': 'DEVICE', 'otherNames': ['Beautifil Flow, Shofu, Kyoto, Japan'], 'description': "Beautiful Flow is a Giomer contained, fluoride releasing and light cured material. The product contains pre-reacted glass ionomer particles (PRG). It is a high water resistant material. It is used for fissure sealant.\n\nTest 3 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 7% phosphoric acid was applied to all surfaces of the tooth for 10 seconds. Then the tooth surface was rinsed with water and dried. Afterwards, a two-stage self-etch adhesive system was applied. Thereafter, Beautiful Flow was applied in compliance with the manufacturers' instructions.", 'armGroupLabels': ['Group 3 (Beautiful Flow- Fuji Triage)']}, {'name': 'Fuji Triage® CAPSULE', 'type': 'DEVICE', 'otherNames': ['Fuji Triage® CAPSULE, GC Corporation, Tokyo, Japan'], 'description': "Fuji Triage® is a new generation glass ionomer containing with low viscosity, high fluoride content and light curing materials. Since the product is tolerant of moisture and saliva, it is used for fissure sealant of newly erupted teeth.\n\nControl newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.Then the tooth surface was rinsed with water and dried. Thereafter,Fuji Triage® was applied to the pits and fissures on the tooth surface using a brush. Thereafter, the varnish was applied and cured according to the manufacturer's instructions.", 'armGroupLabels': ['Group 1 (Fuji II LC-Fuji Triage)', 'Group 2 (Clinpro XT Varnish-Fuji Triage)', 'Group 3 (Beautiful Flow- Fuji Triage)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Katip Celebi University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Merve Akcay, assoc. prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Izmir Katip Celebi Uni'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Katip Celebi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr.', 'investigatorFullName': 'Merve AKCAY', 'investigatorAffiliation': 'Izmir Katip Celebi University'}}}}