Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-30 @ 7:44 AM
Study NCT ID:
NCT05594134
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2022-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of an Automatic Toothbrush
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2022-10-21', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in full mouth plaque score', 'timeFrame': '5 minutes', 'description': 'Difference in full mouth plaque score between before and after brushing'}], 'secondaryOutcomes': [{'measure': 'Perception of "clean mouth"', 'timeFrame': '5 minutes', 'description': 'Sensation of "clean mouth" assessed on a visual analogue scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Plaque']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the efficacy in terms of bacterial plaque removal, in a single use, of a new Y-shaped automatic electric toothbrush with nylon bristles, compared with the electric toothbrush of similar shape but with silicone bristles, with the manual toothbrush, and with a negative control (no brushing) in a group of volunteer students.\n\nPrimary endpoint: difference in "full mouth plaque score" between before and after brushing.\n\nSecondary endpoint: sensation of "clean mouth" assessed on VAS scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth.\n\nSingle-center, randomized, controlled, superiority, cross-over, examiner-blinded study with 5 treatments (Y-shaped electric toothbrush with nylon bristles, similarly shaped electric toothbrush with silicone bristles, manual brushing for 45 seconds, manual brushing for 2 minutes, no brushing), carried out in a single session and spaced one week apart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Absence of fixed orthodontic appliances\n* Presence of at least 20 teeth\n* Full mouth plaque score greater than 40%\n* Having provided signed and dated informed consent.\n\nExclusion Criteria:\n\n* Subjects with manual inability to perform normal oral hygiene maneuvers\n* Subjects allergic to silicone or nylon.'}, 'identificationModule': {'nctId': 'NCT05594134', 'briefTitle': 'Efficacy of an Automatic Toothbrush', 'organization': {'class': 'OTHER', 'fullName': 'University of Florence'}, 'officialTitle': 'Efficacy of an Automatic Toothbrush With Nylon Bristles in Removing Dental Plaque: a Randomized Cross-over Study', 'orgStudyIdInfo': {'id': 'IUFET2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Automatic toothbrush with nylon bristles', 'interventionNames': ['Other: Automatic toothbrush with nylon bristle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Automatic toothbrush with silicone bristles', 'interventionNames': ['Other: Automatic toothbrush with silicone bristle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual toothbrush used for 2 minutes', 'interventionNames': ['Other: Manual toothbrush used for 2 minutes']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual toothbrush used for 45 seconds', 'interventionNames': ['Other: Manual toothbrush used for 45 seconds']}, {'type': 'NO_INTERVENTION', 'label': 'No brushing'}], 'interventions': [{'name': 'Automatic toothbrush with nylon bristle', 'type': 'OTHER', 'description': 'The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch', 'armGroupLabels': ['Automatic toothbrush with nylon bristles']}, {'name': 'Automatic toothbrush with silicone bristle', 'type': 'OTHER', 'description': 'The automatic toothbrush with silicone bristles will be used for 10 seconds', 'armGroupLabels': ['Automatic toothbrush with silicone bristles']}, {'name': 'Manual toothbrush used for 2 minutes', 'type': 'OTHER', 'description': 'A conventional manual toothbrush will be used for 2 minutes', 'armGroupLabels': ['Manual toothbrush used for 2 minutes']}, {'name': 'Manual toothbrush used for 45 seconds', 'type': 'OTHER', 'description': 'A conventional manual toothbrush will be used for 45 seconds', 'armGroupLabels': ['Manual toothbrush used for 45 seconds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50127', 'city': 'Florence', 'country': 'Italy', 'facility': 'School of Dentistry, The University of Florence', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florence', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lorenzo Franchi', 'investigatorAffiliation': 'University of Florence'}}}}