Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT06561204
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2024-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Full-mouth Electronic Toothbrush vs. Conventional Electronic Toothbrush
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2024-08-16', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Löe & Silness gingival index (GI)', 'timeFrame': 'Baseline and 30-days', 'description': 'Scale 0-3'}, {'measure': 'Turesky modification of the Quigley-Hein index', 'timeFrame': 'Baseline and 30-days', 'description': 'Scale 0-5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Toothbrush', 'Gingivitis', 'Plaque']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized, masked-examiner clinical trial is to investigate a full-mouth electronic toothbrush (FMET). The three arms are: 1) FMET + American Dental Association (ADA) approved dentifrice, 2) conventional electronic toothbrush (ETB) + ADA dentifrice and 3) FMET + foam system.', 'detailedDescription': 'The primary purpose is to compare the FMET + ADA dentifrice to the conventional ETB + ADA dentifrice. The exploratory aim is to compare the FMET + foam system to both the FMET + ADA dentifrice and conventional ETB + ADA dentifrice. Baseline and 30-day outcome measures will be collected to evaluate the impact on clinical indicators of gingivitis, plaque, and patient perceptions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* University of Minnesota School of Dentistry patient of record who is 18 years of age or older.\n* Documented periodontal classification of mild to moderate gingivitis (\\>10% BOP) or documented gingivitis on an intact, reduce, or stable with a history of periodontitis in AxiUm electronic health record (EHR) \\>10% BOP.\n* A minimum of 25% plaque measured O'Leary plaque score.\n* A minimum of five natural teeth in each quadrant (excluding third molars, dental implants or teeth with more that ½ of natural surface restored).\n* Be willing to abstain from all professional oral hygiene care (prophy/periodontal maintenance) during the study.\n* Be willing to abstain from the use of any other dental cleaning aids (dental floss, water flossers, interdental brushes, dental or tooth picks, mouthwash, etc.) during the study.\n* Access to personal email account and a device connected to the internet to complete questionnaires and communicate with study team.\n\nExclusion Criteria:\n\n* Presence of aggressive, necrotizing, uncommon periodontal disease, or any uncontrolled periodontal condition.\n* Presence of any physical limitation or restriction that might preclude normal oral hygiene procedures (i.e. need another individual to perform oral self-care).\n* Fixed prosthesis (i.e. implant retained denture), orthodontic appliance or under orthodontic treatment.\n* Any medication that may impact periodontal conditions (i.e., phenytoin, calcium antagonists, cyclosporin, warfarin, antimicrobials, or steroids).\n* Have any uncontrolled medical condition or immunocompromised that may impact the study (i.e. uncontrolled diabetes HbA1c \\> 7, HIV).\n* Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported)\n* ≥2 weeks of antibiotic use in the past three months. Or antibiotic use in the last six weeks.\n* Cigarette use within the last year\n* Unable to comply with the study protocol"}, 'identificationModule': {'nctId': 'NCT06561204', 'briefTitle': 'Full-mouth Electronic Toothbrush vs. Conventional Electronic Toothbrush', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Impact of a Full-mouth Electronic Toothbrush on Indicators of Gingivitis and Patient Perceptions: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'STUDY00022906'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FMET + ADA dentifrice', 'description': 'Baseline and 30-day outcome measures will be collected to evaluate the impact of FMET + ADA dentifrice on clinical indicators of gingivitis, plaque, and patient perceptions.', 'interventionNames': ['Device: FMET']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional electronic toothbrush + ADA dentifrice', 'description': 'Baseline and 30-day outcome measures will be collected to evaluate the impact of conventional electronic toothbrush + ADA dentifrice on clinical indicators of gingivitis, plaque, and patient perceptions.'}, {'type': 'OTHER', 'label': 'FMET + Foam', 'description': 'Baseline and 30-day outcome measures will be collected to evaluate the impact of FMET + foam on clinical indicators of gingivitis, plaque, and patient perceptions.', 'interventionNames': ['Device: FMET']}], 'interventions': [{'name': 'FMET', 'type': 'DEVICE', 'description': 'A full-mouth electronic toothbrush', 'armGroupLabels': ['FMET + ADA dentifrice', 'FMET + Foam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota School of Dentistry', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Michelle C Arnett, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'FENO.Co', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}