Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-25 @ 8:25 PM
Study NCT ID:
NCT02401360
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2015-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-04', 'studyFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingivitis', 'timeFrame': 'Day 0', 'description': 'Gingivitis was assessed according to the Gingival Bleeding Index'}, {'measure': 'Gingivitis', 'timeFrame': 'Day 3', 'description': 'Gingivitis was assessed according to the Gingival Bleeding Index'}, {'measure': 'Gingivitis', 'timeFrame': 'Day 10', 'description': 'Gingivitis was assessed according to the Gingival Bleeding Index'}, {'measure': 'Gingivitis', 'timeFrame': 'Day 24', 'description': 'Gingivitis was assessed according to the Gingival Bleeding Index'}], 'secondaryOutcomes': [{'measure': 'Plaque Examination', 'timeFrame': 'Day 0', 'description': 'The Modified Turesky Plaque Index was used to examine plaque.'}, {'measure': 'Plaque Examination', 'timeFrame': 'Day 3', 'description': 'The Modified Turesky Plaque Index was used to examine plaque.'}, {'measure': 'Plaque Examination', 'timeFrame': 'Day 10', 'description': 'The Modified Turesky Plaque Index was used to examine plaque.'}, {'measure': 'Plaque Examination', 'timeFrame': 'Day 24', 'description': 'The Modified Turesky Plaque Index was used to examine plaque.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Plaque', 'Dental Gingivitis']}, 'descriptionModule': {'briefSummary': 'This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed toothpaste and manual toothbrush.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* give written informed consent prior to their participation;\n* be 18 to 65 years of age at the time of enrollment;\n* agree not to participate in any other oral/dental product studies;\n* agree to delay any elective dentistry (including a dental prophylaxis);\n* agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study;\n* agree to return for the scheduled visits and follow study procedures;\n* be in good general health as determined by the investigator/designee based on a review of the health history/update for participation in the study;\n* have more than 10 bleeding sites at visits 1-3\n* Consistency of bleeding site number at baseline may be considered;\n* have a minimum of 18 natural teeth with facial and lingual scorable surfaces; and\n* refrain from performing any oral hygiene or consuming anything by mouth (except a small amount of water) at least 4 hours prior to their appointment.\n\nExclusion Criteria:\n\n* teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus\n* antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam\n* medical conditions that the investigator considers significant and that may compromise the evaluation of study results\n* currently participating in any other clinical trial\n* participated in a clinical trial for plaque/gingivitis within the previous 30 days\n* pregnant or lactating\n* orthodontic appliances or removable partial dentures\n* soft or hard tissue tumor of the oral cavity\n* advanced periodontal disease\n* history of hepatitis, diabetes, or other communicable diseases\n* history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures\n* history of significant adverse effects following the use of oral hygiene products such as toothpaste\n* oral pathoses that could interfere with compliance and/or examinations or that need treatment.'}, 'identificationModule': {'nctId': 'NCT02401360', 'briefTitle': 'A Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'Procter and Gamble'}, 'officialTitle': 'A Controlled Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products', 'orgStudyIdInfo': {'id': '2012135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Oral care regimen', 'interventionNames': ['Drug: China Crest® Pro-health 7 Complete Toothpaste']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Toothbrush and toothpaste', 'interventionNames': ['Drug: China Crest® Cavity Protection Toothpaste']}], 'interventions': [{'name': 'China Crest® Pro-health 7 Complete Toothpaste', 'type': 'DRUG', 'description': 'Crest® pro-health manual toothbrush Crest® pro-health gum protection rinse', 'armGroupLabels': ['Experimental Group']}, {'name': 'China Crest® Cavity Protection Toothpaste', 'type': 'DRUG', 'description': 'Crest® meliliangje manual toothbrush', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tao He, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Procter and Gamble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procter and Gamble', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}