Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 11:20 AM
Study NCT ID:
NCT07428603
Status:
COMPLETED
Last Update Posted:
2026-02-24
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extrinsic Tooth Whitening Evaluation of a Whitening Toothpaste
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subject-Reported Whitening and Sensory Assessments', 'timeFrame': 'Baseline and Days 7, 14, 28, and 42', 'description': 'Subject-reported perceptions of whitening, mouthfeel, and sensory responses collected via questionnaires.'}], 'primaryOutcomes': [{'measure': 'Change in Extrinsic Tooth Stain (Total Stain Score)', 'timeFrame': 'Baseline to Day 42', 'description': 'Mean change in total extrinsic stain score measured on the labial surfaces of the 12 anterior teeth using the Macpherson Modification of the Lobene Stain Index, combining stain intensity and stain area scores.'}], 'secondaryOutcomes': [{'measure': 'Change in Stain Intensity and Stain Area Scores', 'timeFrame': 'Baseline to Days 7, 14, 28, and 42', 'description': 'Mean changes in stain intensity and stain area scores at each post-baseline time point.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tooth whitening; extrinsic stain; whitening toothpaste; Macpherson Lobene Stain Index; dentifrice; stain removal'], 'conditions': ['Stain Removal Efficacy']}, 'descriptionModule': {'briefSummary': 'This randomized, examiner-blind, parallel-group clinical study evaluated the effectiveness of a whitening toothpaste compared with a control toothpaste in removing extrinsic tooth stain over six weeks of twice-daily unsupervised use. Adult subjects were assessed at baseline and after 7, 14, 28, and 42 days of product use using the Macpherson Modification of the Lobene Stain Index. Oral soft and hard tissues and subject-reported sensory responses were also evaluated throughout the study.', 'detailedDescription': 'This single-site, randomized, examiner-blind, two-cell parallel clinical trial enrolled adult subjects with qualifying extrinsic tooth stain. Following baseline assessments, subjects were randomized to either a test whitening dentifrice or a marketed control dentifrice. Subjects brushed twice daily for two minutes with their assigned toothpaste and toothbrush for 42 days. Extrinsic stain on the labial surfaces of the 12 anterior teeth was evaluated at baseline and at Days 7, 14, 28, and 42 using the Macpherson Modification of the Lobene Stain Index, assessing stain intensity, stain area, and total stain scores. Safety was monitored via oral soft and hard tissue examinations and subject-reported sensory assessments. Treatment comparisons were performed using ANCOVA with baseline scores as covariates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18-65 years in good general health\n* Mean MLSI score ≥1.5 on labial surfaces of at least 8 of 12 anterior teeth\n* Adequate oral hygiene and willingness to comply with study requirements\n* Dental prophylaxis within past 18 months but not within past 3 months\n* Willing to refrain from other whitening or oral care products during the study\n\nExclusion Criteria:\n\n* Significant medical conditions or oral pathology affecting assessments\n* History of adverse reactions to oral hygiene products\n* Orthodontic appliances or restorations interfering with stain assessment\n* Moderate or advanced periodontitis\n* Recent bleaching or whitening treatments\n* Pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT07428603', 'briefTitle': 'Extrinsic Tooth Whitening Evaluation of a Whitening Toothpaste', 'organization': {'class': 'INDUSTRY', 'fullName': 'Church & Dwight Company, Inc.'}, 'officialTitle': 'Six-Week Clinical Evaluation of a Toothpaste in Tooth Whitening Via Extrinsic Stain Removal', 'orgStudyIdInfo': {'id': 'ST-24-U46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Toothpaste', 'description': 'Investigational whitening toothpaste evaluated for removal of extrinsic tooth stain over 42 days of use.', 'interventionNames': ['Other: Whitening Test Dentifrice (Code 826)']}, {'type': 'OTHER', 'label': 'Sodium Fluoride Control Dentifrice', 'description': 'Non-whitening toothpaste used twice daily for two minutes per brushing for six weeks.', 'interventionNames': ['Other: Control dentifrice (Code 378)']}], 'interventions': [{'name': 'Whitening Test Dentifrice (Code 826)', 'type': 'OTHER', 'description': 'Whitening toothpaste used twice daily for two minutes per brushing for six weeks.', 'armGroupLabels': ['Test Toothpaste']}, {'name': 'Control dentifrice (Code 378)', 'type': 'OTHER', 'description': 'Non-whitening toothpaste used twice daily for two minutes per brushing for six weeks.', 'armGroupLabels': ['Sodium Fluoride Control Dentifrice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46825', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Salus Research, Inc.', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}], 'overallOfficials': [{'name': 'Annahita Ghassemi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Church & Dwight, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The sponsor does not plan to share individual participant data. Aggregate results are reported, but no de-identified datasets will be made publicly available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Church & Dwight Company, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}