Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT05969756
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-20
First Post:
2023-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Treatments for Preventing Occlusal Caries Lesions
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinding of examiners is impossible to be done during intervention and follow up due to different natures of the materials. However, participants and outcome assessors could be blinded (double blinding).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a 3 arm clinical trial. All selected permanent molars will be randomly equally allocated into three groups according to material used.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2023-07-23', 'studyFirstSubmitQcDate': '2023-07-23', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of new caries lesion', 'timeFrame': '3 months', 'description': 'ICDAS was considered "0\'\' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion'}, {'measure': 'Development of new caries lesion', 'timeFrame': '6 months', 'description': 'ICDAS was considered "0\'\' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion'}, {'measure': 'Development of new caries lesion', 'timeFrame': '9 months', 'description': 'ICDAS was considered "0\'\' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion'}, {'measure': 'Development of new caries lesion', 'timeFrame': '12 months', 'description': 'ICDAS was considered "0\'\' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion'}], 'secondaryOutcomes': [{'measure': 'Sealants retention', 'timeFrame': '3 months', 'description': 'Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.'}, {'measure': 'Sealants retention', 'timeFrame': '6 months', 'description': 'Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.'}, {'measure': 'Sealants retention', 'timeFrame': '9 months', 'description': 'Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.'}, {'measure': 'Sealants retention', 'timeFrame': '12 months', 'description': 'Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.'}, {'measure': 'Quality of sealants', 'timeFrame': '3 months', 'description': 'Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.'}, {'measure': 'Quality of sealants', 'timeFrame': '6 months', 'description': 'Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.'}, {'measure': 'Quality of sealants', 'timeFrame': '9 months', 'description': 'Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.'}, {'measure': 'Quality of sealants', 'timeFrame': '12 months', 'description': 'Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early caries lesions', 'sealants', 'erupting molars'], 'conditions': ['Caries; Initial', 'Occlusal Caries', 'Caries,Dental']}, 'descriptionModule': {'briefSummary': 'Sealants effectively arrest non-cavitated caries lesions on the fully erupted occlusal surface of permanent teeth. However, the clinical effectiveness of sealants is uncertain in preventing occlusal caries lesions in partially erupted permanent molars. This study aims to evaluate the progression of caries, the degree of retention, survival rate, and quality of the remnant after applying conventional total-etch resinous sealant and self-etch sealant in erupting molars.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor children:\n\n1. Children presenting with good general health and cooperative behavior.\n2. Children having early caries lesions in a permanent molar (first or second).\n3. Parents signed informed consent.\n\nFor permanent molars:\n\n1. Early caries lesions on the occlusal surface corresponding to International Caries Detection and Assessment System (ICDAS) scores 1 and 2. \\[Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8\\].\n2. Erupting molars: eruption stages 2 (fully erupted occlusal surface with less than half of the crown exposed) and 3 (fully erupted occlusal surface with more than half of the crown exposed). \\[Carvalho JC, Ekstrand KR, Thylstrup A. Dental plaque and caries on occlusal surfaces of first permanent molars in relation to stage of eruption. J Dent Res. 1989 May;68(5):773-9\\].\n\nExclusion Criteria:\n\nFor children:\n\n1. Any allergy reported by the parents.\n2. Children unable to return for recall visits.\n\nFor permanent molars:\n\n1. Teeth with occlusal surfaces completely covered by the gingival tissue.\n2. Teeth with hypoplastic defects, restorations, or sealants.'}, 'identificationModule': {'nctId': 'NCT05969756', 'briefTitle': 'Early Treatments for Preventing Occlusal Caries Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Hue University of Medicine and Pharmacy'}, 'officialTitle': 'Clinical Effectiveness of Early Treatments for Preventing Occlusal Caries Lesions in Erupting Permanent Molars', 'orgStudyIdInfo': {'id': 'H2023/012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluoride varnish group', 'description': '5% sodium fluoride varnish, 3M, USA', 'interventionNames': ['Drug: Fluoride varnish']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional etch and rinse sealant group', 'description': 'Resin-based composite sealant, 3M, USA', 'interventionNames': ['Drug: Conventional etch and rinse sealant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self-etch sealant group', 'description': 'Self-etch primed sealant, Shofu, Japan', 'interventionNames': ['Drug: Self-etch sealant']}], 'interventions': [{'name': 'Fluoride varnish', 'type': 'DRUG', 'otherNames': ['3M™ Clinpro™ White Varnish'], 'description': 'Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months', 'armGroupLabels': ['Fluoride varnish group']}, {'name': 'Conventional etch and rinse sealant', 'type': 'DRUG', 'otherNames': ['3M™ Clinpro™ Sealant'], 'description': 'Thirty-eight permanent molars will receive conventional etch and rinse sealant', 'armGroupLabels': ['Conventional etch and rinse sealant group']}, {'name': 'Self-etch sealant', 'type': 'DRUG', 'otherNames': ['S-PRG filler-containing resin sealant', 'Beautisealant'], 'description': 'Thirty-eight permanent molars will receive self-etch sealant', 'armGroupLabels': ['Self-etch sealant group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49120', 'city': 'Huế', 'state': 'Thừa Thiên Huế Province', 'country': 'Vietnam', 'facility': 'Hue University of Medicine and Pharmacy', 'geoPoint': {'lat': 16.4619, 'lon': 107.59546}}, {'zip': '49900', 'city': 'Phú Vang', 'state': 'Thừa Thiên Huế Province', 'country': 'Vietnam', 'facility': 'Phu Vang Hospital', 'geoPoint': {'lat': 16.43911, 'lon': 107.71438}}], 'overallOfficials': [{'name': 'Van Nhat Thang Le, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hue University of Medicine and Pharmacy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Plan to complete study in 1 year and will share the data after get publication', 'ipdSharing': 'YES', 'description': 'Will plan to share information when finishing study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hue University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, PhD, Principal Investigator', 'investigatorFullName': 'Le Van Nhat Thang', 'investigatorAffiliation': 'Hue University of Medicine and Pharmacy'}}}}