Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT03047759
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2016-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Interdental Cleaners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2016-08-17', 'studyFirstSubmitQcDate': '2017-02-07', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding upon probing', 'timeFrame': '4 weeks', 'description': 'Bleeding upon probing'}], 'secondaryOutcomes': [{'measure': 'Gingivitis', 'timeFrame': '4 weeks', 'description': 'Modified Gingival \\\\index'}, {'measure': 'Plaque', 'timeFrame': '4 weeks', 'description': 'Rustogi Modification of the Navy Plaque Index'}]}, 'conditionsModule': {'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.', 'detailedDescription': 'This study measured plaque accumulation, bleeding on probing and gingivitis using the Rustogi Modification of the Navy Plaque Index, BOP and Modified Gingival Index at baseline, 2-weeks and 4-weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult\n* Non smoker\n* Available for 4-weeks\n* Able to provide written informed consent.\n* Minimum of 20 natural teeth.\n* Minimum requirement for plaque, gingivitis and bleeding.\n\nExclusion Criteria:\n\n* Medical condition\n* No antibiotics within 6 months of study start\n* Not on any medication (impact oral health).'}, 'identificationModule': {'nctId': 'NCT03047759', 'briefTitle': 'Comparison of Two Interdental Cleaners', 'organization': {'class': 'OTHER', 'fullName': 'All Sum Research Center Ltd.'}, 'orgStudyIdInfo': {'id': '2016-WP-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention A', 'description': 'water flosser', 'interventionNames': ['Device: water flosser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention B', 'description': 'air floss', 'interventionNames': ['Device: air floss']}], 'interventions': [{'name': 'water flosser', 'type': 'DEVICE', 'description': 'Powered', 'armGroupLabels': ['Intervention A']}, {'name': 'air floss', 'type': 'DEVICE', 'description': 'Powered', 'armGroupLabels': ['Intervention B']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All Sum Research Center Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}