Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-28 @ 7:24 PM
Study NCT ID:
NCT05791669
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2022-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C024633', 'term': 'silver diamine fluoride'}, {'id': 'C094502', 'term': 'Bifluorid 12'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2022-11-12', 'studyFirstSubmitQcDate': '2023-03-17', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caries arrest', 'timeFrame': '12 months', 'description': 'Assessment with bitewing radiographs based on ICCMS radiographic scoring system'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caries arrest ,interproximal caries, primary molars, SDF'], 'conditions': ['Caries Arrested']}, 'descriptionModule': {'briefSummary': 'This study was conducted to assess the efficacy of 38% Silver Diamine fluoride and compare it with 5% sodium fluoride varnish in arresting interproximal caries in primary molars at 12 months follow-up. Bitewing radiographs were taken to diagnose as well as to assess caries depth at follow up visits. Each bitewing was scored based on ICCMS radiographic criteria and was compared (follow-ups to baseline)to check for caries arrest.\n\nInterproximal caries included in this study, according to ICCMS criteria, were at stages- RA - caries limited to outer half of enamel RA2 - caries limited to the inner half of enamel RA3 - caries limited to outer third of dentine RA4 - caries limited to middle third of dentine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children aged 5 to 9 years.\n2. Presence of at least 2 primary molars with interproximal caries.\n3. Carious lesions of enamel or outer or middle third of dentin in primary molars, as assessed by bitewing radiographs with ICCMSTM scoring (RA1, RA2, RA3, RB4).\n\nExclusion Criteria:\n\n1\\. Presence of advanced carious lesions reaching inner third of dentin detected by bitewing radiographic examinations ICCMSTM (RC5, RC6).\n\n3\\. Children or adolescents that refuse to participate in the study or present negative behaviours.\n\n4\\. Teeth with premature hypermobility 5. Both physically and mentally disabled children'}, 'identificationModule': {'nctId': 'NCT05791669', 'briefTitle': 'Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution', 'organization': {'class': 'OTHER', 'fullName': 'Postgraduate Institute of Dental Sciences Rohtak'}, 'officialTitle': 'Arrest of Interproximal Caries Lesion in Primary Molars With 38% Silver Diamine Fluoride Solution and 5% Sodium Fluoride Varnish: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'PGIDS/BHRC/21/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '38% silver diamine fluoride', 'interventionNames': ['Drug: Silver diamine fluoride']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5% sodium fluoride varnish', 'interventionNames': ['Drug: Sodium fluoride varnish']}], 'interventions': [{'name': 'Silver diamine fluoride', 'type': 'DRUG', 'otherNames': ['FAgamin SDF38%'], 'description': 'Silver diamine fluoride is a topical medication composed of 25% silver, 5% fluoride, 8% ammonia, and 62% Deionized water, used to treat and prevent dental caries and relieve dentinal hypersensitivity.', 'armGroupLabels': ['38% silver diamine fluoride']}, {'name': 'Sodium fluoride varnish', 'type': 'DRUG', 'otherNames': ['VOCO profluorid varnish'], 'description': 'It is a topical application with an active ingredient of 5% sodium fluoride(22,600ppm fluoride).it prolongs the contact time between the fluoride and tooth surface and promotes remineralization and inhibits demineralization.', 'armGroupLabels': ['5% sodium fluoride varnish']}]}, 'contactsLocationsModule': {'locations': [{'zip': '124001', 'city': 'Rohtak', 'state': 'Haryana', 'country': 'India', 'facility': 'Post graduate institute of dental sciences', 'geoPoint': {'lat': 28.89447, 'lon': 76.58917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Postgraduate Institute of Dental Sciences Rohtak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}