Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-28 @ 7:34 AM
Study NCT ID:
NCT06131957
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2023-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Root Caries Prevention Using Fluoride Varnish Fortified With SBGC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017213', 'term': 'Root Caries'}], 'ancestors': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C023807', 'term': 'sodium fluoride topical preparation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "The subjects and the clinical team including the dentist and the dental surgery assistant will all be blinded to the subjects' assignment of the intervention."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized assigned to either experimental group or controlled group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 540}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2023-11-08', 'studyFirstSubmitQcDate': '2023-11-12', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New root caries lesions and restorations', 'timeFrame': 'Baseline, 12, 24, 36 months', 'description': 'All exposed root surfaces will be examined for new caries lesions based on the ICDAS criteria. Restorations due to root caries will also be recorded after confirmation with the subjects.'}], 'secondaryOutcomes': [{'measure': 'Arrested root caries', 'timeFrame': 'Baseline, 12, 24, 36 months', 'description': 'An active root caries lesion found at baseline changed into inactive at follow-ups, according to ICDAS II criteria.'}, {'measure': 'Satisfaction of the use of varnish', 'timeFrame': '12, 24, 36 months', 'description': 'Investigated by survey.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Strontium-doped Bioactive Glass Ceramic', 'Fluoride varnish', 'Older adults', 'Root caries', 'Dentine', 'Prevention'], 'conditions': ['Dental Caries of Root Surface', 'Root Caries']}, 'descriptionModule': {'briefSummary': 'The goal of this 36-month double-blind randomized controlled trial is to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped bioactive glass (SBGC) on root caries development in community-dwelling older adults.', 'detailedDescription': 'This 36-month, double-blind, two-arm randomized controlled trial is aimed to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped bioactive glass (SBGC) on root caries development in community-dwelling older adults.\n\nParticipants will be divided in to two groups, The main question it aims to answer is: Is fluoride varnish with SBGC more effective than that without SBGC on prevention root caries in community-dwelling older adults? Participants will be divided into two groups, experimental group and controlled group after randomization. Subjects in the experimental group will receive fluoride varnish with SBGC quarterly, and subjects in the controlled group will receive fluoride varnish without SBGC quarterly.\n\nIt is hypothesized that community-dwelling older adults who receive quarterly fluoride varnish applications containing SBGC will develop fewer root caries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult \\> 60 years old\n* good collaborative relationships\n\nExclusion Criteria:\n\n* less than 8 natural teeth\n* have severe medical conditions\n* are in use of high fluoride toothpaste'}, 'identificationModule': {'nctId': 'NCT06131957', 'acronym': 'SBGC', 'briefTitle': 'Root Caries Prevention Using Fluoride Varnish Fortified With SBGC', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Root Caries Prevention Using Fluoride Varnish Fortified With Strontium-doped Bioactive Glass Ceramic: a Randomized Double-blind Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'UW23-451'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluoride varnish with SBGC', 'description': 'This group will receive applications of fluoride varnish (containing 5% NaF) with 7.5% SBGC every 3 months for 36 months.', 'interventionNames': ['Combination Product: Fluoride varnish with SBGC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoride varnish without SBGC', 'description': 'This group will receive 5% NaF varnish with SBGC every 3 months for 36 months.', 'interventionNames': ['Drug: Fluoride varnish']}], 'interventions': [{'name': 'Fluoride varnish with SBGC', 'type': 'COMBINATION_PRODUCT', 'description': 'The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA) mixed with 7.5% SBGC (Dencare (Chongqing) Oral Care Co., Ltd).', 'armGroupLabels': ['Fluoride varnish with SBGC']}, {'name': 'Fluoride varnish', 'type': 'DRUG', 'otherNames': ['Duraphat'], 'description': 'The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA)', 'armGroupLabels': ['Fluoride varnish without SBGC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Clinical Research Center, the Prince Philips Dental Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Katherine CM Leung, BDS,MDS,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}