Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT06300905
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2024-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study on Malodor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-03', 'studyFirstSubmitDate': '2024-03-03', 'studyFirstSubmitQcDate': '2024-03-03', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Organoleptic Oral Malodor Evaluations', 'timeFrame': 'Oral malodor evaluations at baseline & 3 weeks', 'description': 'The measured levels of oral malodor will be expressed in organoleptic scales (1-9)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Organoleptic method', 'oral malodor'], 'conditions': ['Oral Malodor']}, 'descriptionModule': {'briefSummary': 'This 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of product use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be male or female 18 to 70 years of age\n* Must be in good general health\n* Must be in good oral health based on self-assessment\n* Must be available during the weeks of this study for all appointment time points\n* Should have a minimum of 20 natural uncrowned teeth (excluding third molars)\n* Should have a baseline mean oral malodor score greater than or equal to 6.0 and less than or equal to 8.0\n* Must give written informed consent\n* No known history of allergy to personal care/consumer products or their ingredients\n\nExclusion Criteria:\n\n* Participation in any other oral clinical studies for the duration of this study\n* Full or partial (upper or lower) dentures\n* Pregnant or lactating (breast feeding)\n* Use of tobacco products\n* History of allergy to common toothpaste ingredients\n* Use of phenolic flavored products, such as mint flavored candies and chewing gum, the morning of the study and during the sampling periods\n* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)\n* Individuals who, due to medical conditions, cannot go without eating or drinking for the post use treatment evaluation time points (6 hrs. + overnight)'}, 'identificationModule': {'nctId': 'NCT06300905', 'briefTitle': 'Clinical Study on Malodor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'Clinical Investigation on Oral Malodor for a New Formula of Stannous Toothpaste as Compared to Colgate Cavity Protection Toothpaste Using Organoleptic Method', 'orgStudyIdInfo': {'id': 'CRO-2023-05-OMO-SNA-YPZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'Brushing twice daily in the morning and evening with 2 minutes each time', 'interventionNames': ['Drug: test product', 'Drug: Control product']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'Brushing twice daily in the morning and evening with 2 minutes each time', 'interventionNames': ['Drug: test product', 'Drug: Control product']}], 'interventions': [{'name': 'test product', 'type': 'DRUG', 'description': 'toothpaste containing 0.45% stannous fluoride', 'armGroupLabels': ['Group I', 'Group II']}, {'name': 'Control product', 'type': 'DRUG', 'description': 'toothpaste containing 0.76% sodium monofluorophosphate', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Dental Institute of Chengdu', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Deyu Hu, DDS,MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Dental Institute of Chengdu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}