Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2026-02-25 @ 2:43 AM
Study NCT ID:
NCT03049761
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2017-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Water Flosser vs String Floss vs Manual Toothbrush Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017695', 'term': 'Soft Tissue Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a examiner-masked, 3-treatment, randomized clinical trial comparing the safety of different oral hygiene regimens.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2017-02-07', 'studyFirstSubmitQcDate': '2017-02-09', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Attachment Levels', 'timeFrame': '6 weeks', 'description': 'Measurement from the junction Epithelium to the cemento enamel junction'}], 'secondaryOutcomes': [{'measure': 'Probing pocket depth', 'timeFrame': '6 weeks', 'description': 'Measurement from the junction Epithelium to the free gingival margin'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Soft Tissue Injuries']}, 'descriptionModule': {'briefSummary': 'Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings', 'detailedDescription': 'This study is designed to add to the safety data by measuring, Oral Soft tissue, Clinical Attachment Levels and Probing Pocket Depths on different pressure settings at different time points over a 6 week period. Data will be collected at Baseline, 2 week, 4 week and 6 week time frames.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written consent prior to participation\n* Good general health and non smoker\n* Have scorable Ramfjord's teeth\n\nExclusion Criteria:\n\n* Probing depth \\>4mm on Ramfjord's teeth\n* Moderate to severe gingivitis\n* Advanced periodontitis\n* Medications that impact soft tissue."}, 'identificationModule': {'nctId': 'NCT03049761', 'briefTitle': 'Water Flosser vs String Floss vs Manual Toothbrush Safety', 'organization': {'class': 'OTHER', 'fullName': 'All Sum Research Center Ltd.'}, 'officialTitle': 'Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings', 'orgStudyIdInfo': {'id': '2017-WP-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Water Flosser', 'description': 'Power interdental Cleaning Device', 'interventionNames': ['Device: Water Flosser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'String floss', 'description': 'Manual interdental cleaning device', 'interventionNames': ['Device: String Floss']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual Toothbrush', 'description': 'ADA standard manual toothbrush', 'interventionNames': ['Device: Manual Toothbrush']}], 'interventions': [{'name': 'Water Flosser', 'type': 'DEVICE', 'description': 'Power interdental cleaner', 'armGroupLabels': ['Water Flosser']}, {'name': 'String Floss', 'type': 'DEVICE', 'description': 'Mechanical interdental cleaner', 'armGroupLabels': ['String floss']}, {'name': 'Manual Toothbrush', 'type': 'DEVICE', 'description': 'ADA standard soft bristle toothbrush', 'armGroupLabels': ['Manual Toothbrush']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All Sum Research Center Ltd.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Water Pik, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}