Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-01 @ 9:59 PM
Study NCT ID:
NCT06632704
Status:
COMPLETED
Last Update Posted:
2025-04-13
First Post:
2024-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Colgate Assist Handle Toothbrush in Individuals With Impairment of Hand Movement.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009069', 'term': 'Movement Disorders'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'targetDuration': '3 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2024-10-07', 'studyFirstSubmitQcDate': '2024-10-07', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'user experience', 'timeFrame': '1 week, 2 weeks and 3 weeks', 'description': 'User experiences of Colgate Assist Handle toothbrush as indicated by questionnaire and interview Video recording of tooth brushing technique Picture of toothbrush bristles'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['hand movement impairment'], 'conditions': ['Movement Disorders and Physical Impairments']}, 'descriptionModule': {'briefSummary': 'User experiences of Colgate Assist Handle toothbrush as indicated by questionnaire and interview', 'detailedDescription': 'Video recording of tooth brushing technique Picture of toothbrush bristles after study period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of 26 participants, aged 18-70 years old and of record at Penn Dental Medicine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with specific movement disorders and physical impairments, such as, but not limited to, Parkinson disease, Huntington disease, multiple sclerosis, arthritis, cerebral palsy, stroke, and/or tremors that affect their ability to perform daily tasks, such as brushing their teeth.\n\nExclusion Criteria:\n\n* Individuals with severe oral health issues such as oral cancer, ulcers, or severe periodontal disease.\n* Individuals who are unable to open their mouth enough that it would prevent using a brushing device.'}, 'identificationModule': {'nctId': 'NCT06632704', 'briefTitle': 'Assessing the Colgate Assist Handle Toothbrush in Individuals With Impairment of Hand Movement.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'Assessing the Colgate Assist Handle Toothbrush in Individuals With Impairment of Hand Movement.', 'orgStudyIdInfo': {'id': 'CRO-2024-04-MTB-ASSIST HANDLE-'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults aged 18-70 yrs, if applicable, primary caregiver', 'description': 'The study population will consist of 26 participants, aged 18-70 years old and of record at Penn Dental Medicine.', 'interventionNames': ['Device: Colgate Toothbrush assist']}], 'interventions': [{'name': 'Colgate Toothbrush assist', 'type': 'DEVICE', 'description': 'toothbrush handle assignment to all subjects; subjects will have a choice between two brush heads', 'armGroupLabels': ['Adults aged 18-70 yrs, if applicable, primary caregiver']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania school of Dental Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Eugene M Ko, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deputy Director, Center for Clinical and Translational Research Clinical Associate Professor, Department of Oral Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}