Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-01 @ 7:19 AM
Study NCT ID:
NCT03185104
Status:
UNKNOWN
Last Update Posted:
2017-06-14
First Post:
2017-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D017213', 'term': 'Root Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024633', 'term': 'silver diamine fluoride'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Application of the SDF/placebo is conducted by a dentist who is not involved in the clinical data collection.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Removable partial denture wearers are randomized assigned to either the fluoride group or the placebo group. The fluoride group receives semi-annually professionally applied 38% SDF solution to all exposed tooth and root surfaces while the placebo group receives distilled water using the same application method.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-09', 'studyFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2017-06-09', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caries increment', 'timeFrame': '36 months', 'description': 'New and recurrent caries lesions are recorded according to the International Caries Detection and Assessment System (ICDAS). Molars and premolars are considered to have 5 coronal surfaces, whereas canines and incisors are considered to have 4. The cleaned and dried teeth are recorded as sound, sealed, restored, crowned, or missing. Each coronal tooth surface is classified using a 7-point ordinal scale ranging from sound to extensive cavitation using a WHO probe. The same procedure is repeated for all root surfaces. Coronal and root surface caries increments are calculated by comparing the baseline and follow-up observations for each tooth surface.'}], 'secondaryOutcomes': [{'measure': 'Prevalence of oral colonization of oral yeasts', 'timeFrame': '36 months', 'description': 'The prevalence of oral yeast in oral rinse and dental plaque is counted. Prevalence is expressed as percentage of the participants.'}, {'measure': 'Colonization of oral yeasts in oral rinse', 'timeFrame': '36 months', 'description': 'The count of oral yeasts in oral rinse is recorded. The count of oral yeast in oral rinse is expressed as colony-forming unit (cfu)/ml.'}, {'measure': 'Colonization of oral yeasts in dental plaque', 'timeFrame': '36 months', 'description': 'The count of oral yeasts in dental plaque is recorded. The count of oral yeast in dental plaque is expressed as cfu/g.'}, {'measure': 'Prevalence of oral colonization of Streptococcus mutans (S. mutans)', 'timeFrame': '36 months', 'description': 'The prevalence S. mutans in stimulated whole saliva (SWS) and dental plaque is counted. Prevalence is expressed as percentage of the participants.'}, {'measure': 'Colonization of S. mutans in saliva', 'timeFrame': '36 months', 'description': 'The count of S. mutans in SWS is recorded. The count of S. mutans in SWS is expressed as cfu/ml.'}, {'measure': 'Colonization of S. mutans in dental plaque', 'timeFrame': '36 months', 'description': 'The count of S. mutans dental plaque is recorded. The count of S. mutans in dental plaque is expressed as cfu/g.'}, {'measure': 'Prevalence of oral colonization of lactobacilli', 'timeFrame': '36 months', 'description': 'The prevalence of lactobacilli in SWS and dental plaque is counted. Prevalence is expressed as percentage of the participants.'}, {'measure': 'Colonization of lactobacilli in saliva', 'timeFrame': '36 months', 'description': 'The count of lactobacilli in SWS is recorded. The count of lactobacilli in SWS is expressed as cfu/ml.'}, {'measure': 'Colonization of lactobacilli in dental plaque', 'timeFrame': '36 months', 'description': 'The count of lactobacilli in dental plaque is recorded. The count of lactobacilli in dental plaque is expressed as cfu/g.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['removable partial denture', 'silver diamine fluoride'], 'conditions': ['Dental Caries', 'Dental Caries of Root Surface']}, 'descriptionModule': {'briefSummary': 'This study measures and compares the effect of silver diamine fluoride (SDF) on caries increment in removable partial denture wearers. Half of the participants will SDF and while the other half will receive placebo.', 'detailedDescription': 'Removable partial dentures are commonly constructed to replace missing teeth. It is observed that removable partial denture wearers are susceptible to dental caries.\n\nThe mode of action of silver diamine fluoride on caries prevention is dual: fluoride ions interact synergistically with silver to react with hydroxyapatite to form fluorapatite, and silver is bactericidal by reacting with the thiol groups of the amino and nucleic acids that halt the metabolic and reproductive functions of the cariogenic bacteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are wearing removable partial dentures constructed by staff or students at the Prince Philip Dental Hospital are recruited\n\nExclusion Criteria:\n\n* If they have less than 4 teeth in any dental arch, have advanced periodontal disease in 2 or more sextants, have received therapeutic radiation of the head and neck region, have concurrent systemic illness that alters salivary flow, or have participated in a clinical trial within 6 months before the commencement of participation in this study.'}, 'identificationModule': {'nctId': 'NCT03185104', 'briefTitle': 'Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Randomized Double-blind Placebo-controlled Trial of Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers', 'orgStudyIdInfo': {'id': 'SDF RPD wearers'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Silver diamine fluoride', 'description': '38% silver diamine fluoride solution (Saforide, Toyo Seiyaku Kasei Co. Ltd., Osaka, Japan) is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months.', 'interventionNames': ['Drug: Silver Diamine Fluoride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Distilled water', 'description': 'Distilled water is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months.', 'interventionNames': ['Drug: Distilled Water']}], 'interventions': [{'name': 'Silver Diamine Fluoride', 'type': 'DRUG', 'otherNames': ['Saforide'], 'description': 'Silver diamine fluoride solution is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.', 'armGroupLabels': ['Silver diamine fluoride']}, {'name': 'Distilled Water', 'type': 'DRUG', 'description': 'Distilled water is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.', 'armGroupLabels': ['Distilled water']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Katherine CM Leung, BDS,MDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}