Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-28 @ 2:16 AM
Study NCT ID:
NCT05392868
Status:
UNKNOWN
Last Update Posted:
2023-07-25
First Post:
2022-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 166}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-23', 'studyFirstSubmitDate': '2022-05-22', 'studyFirstSubmitQcDate': '2022-05-22', 'lastUpdatePostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in dentine hypersensitivity', 'timeFrame': 'at 8-week follow-up', 'description': 'the percentage of change in self-perceived sensitivity score (SS)'}], 'secondaryOutcomes': [{'measure': 'Change in oral hygiene status', 'timeFrame': 'at 8-week follow-up', 'description': 'the percentage of change in visible plaque index'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dentine Hypersensitivity']}, 'referencesModule': {'references': [{'pmid': '37454789', 'type': 'DERIVED', 'citation': 'Chan AKY, Tsang YC, Jiang CM, Leung KCM, Lo ECM, Chu CH. Treating hypersensitivity in older adults with silver diamine fluoride: A randomised clinical trial. J Dent. 2023 Sep;136:104616. doi: 10.1016/j.jdent.2023.104616. Epub 2023 Jul 14.'}, {'pmid': '36286004', 'type': 'DERIVED', 'citation': 'Chan AKY, Tamrakar M, Jiang CM, Tsang YC, Leung KCM, Chu CH. Effectiveness of 38% Silver Diamine Fluoride in Reducing Dentine Hypersensitivity on Exposed Root Surface in Older Chinese Adults: Study Protocol for a Randomised Double-Blind Study. Dent J (Basel). 2022 Oct 19;10(10):194. doi: 10.3390/dj10100194.'}]}, 'descriptionModule': {'briefSummary': 'Background: Dentine hypersensitivity is a common oral complaint from older adults. It induces pain, affects oral hygiene practice, limits food choices and negatively affects the quality of life. Silver diamine fluoride (SDF) is a desensitizing agent but well-designed clinical trials are lacking. The objective of this study is to evaluate the effectiveness of SDF in reducing dentine hypersensitivity in older Chinese adults.\n\nMethods: This is a double-blinded randomised clinical trial recruiting 166 healthy older adults aged 65 or over after having written consent. A trained calibrated examiner will conduct clinical examination and assess dentine hypersensitive using a blast of compressed air delivered from 3-in-1 syringe. Older adults with a tooth with a self-perceived sensitivity score (SS) of 8 or above will be recruited. They will then be block randomised to receive either 38% SDF solution or 5% potassium nitrate every 4 weeks on the exposed root surface of the most hypersensitive tooth. The visible plaque index, bleeding on probing and probing depth (mm) will be recorded on the most hypersensitive tooth. The same examiner will perform clinical examination and assess the dentine hypersensitivity using the same tools and methods at 4-week and 8-week follow-ups. The examiner and older adults will be blinded to treatment allocation. The primary outcome is the percentage of change in SS before and after intervention at 8 weeks. The secondary outcome will be the percentage of change in VPI before and after intervention at 8 weeks.\n\nClinical significance: It will provide evidence to manage dentine hypersensitivity in older adults in clinical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* generally healthy;\n* no known or suspected allergy to the study ingredients or materials\n* have all active dental diseases under control but reported hypersensitivity\n\nExclusion Criteria:\n\n* using any desensitizing agent within one month\n* have major systemic diseases such as cancer\n* receive medications that may affect pain perception within one month\n* have dentine hypersensitivity due to other dental conditions such as caries\n* are not able to give written consent'}, 'identificationModule': {'nctId': 'NCT05392868', 'briefTitle': 'Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'A Clinical Protocol on the Effectiveness of 38% Silver Diamine Fluoride in Reducing Dentine Hypersensitivity on Exposed Root Surface in Older Chinese Adults', 'orgStudyIdInfo': {'id': 'HKU2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SDF', 'description': '38% silver diamine fluoride solution', 'interventionNames': ['Device: SDF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KNO3', 'description': '5% potassium nitrate solution', 'interventionNames': ['Device: KNO3']}], 'interventions': [{'name': 'SDF', 'type': 'DEVICE', 'description': '38% silver diamine fluoride solution', 'armGroupLabels': ['SDF']}, {'name': 'KNO3', 'type': 'DEVICE', 'description': '5% potassium nitrate solution', 'armGroupLabels': ['KNO3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chun Hung Chu', 'role': 'CONTACT', 'email': 'chchu@hku.hk', 'phone': '00852-28590287'}], 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Chun Hung Chu, PhD', 'role': 'CONTACT', 'email': 'chchu@hku.hk', 'phone': '(+852)28590287'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Chun Hung Chu', 'investigatorAffiliation': 'The University of Hong Kong'}}}}