Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 11:41 PM
Study NCT ID:
NCT00941668
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2008-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate Inflammation Caused by Gingivitis in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014260', 'term': 'Triclosan'}, {'id': 'C546060', 'term': 'hydrated silica gel-based toothpaste'}], 'ancestors': [{'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'William_DeVizio@colpal.com', 'phone': '732-878-7901', 'title': 'Willliam DeVizio-DMD', 'organization': 'Colgate Palmolive'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '29 days', 'eventGroups': [{'id': 'EG000', 'title': 'Total Toothpaste (Active)', 'description': 'triclosan/copolymer/fluoride toothpaste', 'otherNumAtRisk': 24, 'otherNumAffected': 1, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Colgate Cavity Protection (Placebo)', 'description': 'sodium monofluorophosphate toothpaste', 'otherNumAtRisk': 25, 'otherNumAffected': 6, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tooth Sensitivity to Cold', 'notes': 'Subjects reported tooth sensitivity to cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral irritation', 'notes': 'subject reported oral irritation after using the study product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold and/or flu like symptoms', 'notes': '2 subjects reported cold like symptoms halfway through the study and 1 subject reported flu like symptoms (Fever,chills and sore throat) at end of study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pulled muscle', 'notes': '1 subject reported a pulled muscle in their back at the end of the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Toothpaste (Active)', 'description': 'triclosan/copolymer/fluoride toothpaste'}, {'id': 'OG001', 'title': 'Colgate Cavity Protection (Placebo)', 'description': 'sodium monofluorophosphate toothpaste'}], 'classes': [{'categories': [{'measurements': [{'value': '492.2', 'spread': '545.5', 'groupId': 'OG000'}, {'value': '326.3', 'spread': '307.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'The null hypothesis states that there is no difference between groups.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)', 'unitOfMeasure': 'Micrograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Toothpaste (Active)', 'description': 'triclosan/copolymer/fluoride toothpaste'}, {'id': 'OG001', 'title': 'Colgate Cavity Protection (Placebo)', 'description': 'sodium monofluorophosphate toothpaste'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'spread': '23.3', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '46.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The null hypothesis states that there is no difference between groups.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms)', 'unitOfMeasure': 'Micrograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Toothpaste (Active)', 'description': 'triclosan/copolymer/fluoride toothpaste'}, {'id': 'FG001', 'title': 'Colgate Great Regular Flavor (Placebo)', 'description': 'sodium monofluorophosphate toothpaste'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}]}]}], 'recruitmentDetails': 'subjects were recruited by the PI at the clinical site'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Toothpaste (Active)', 'description': 'triclosan/copolymer/fluoride toothpaste'}, {'id': 'BG001', 'title': 'Colgate Cavity Protection (Placebo)', 'description': 'sodium monofluorophosphate toothpaste'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '34', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '36.25', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-18', 'studyFirstSubmitDate': '2008-09-26', 'resultsFirstSubmitDate': '2008-09-26', 'studyFirstSubmitQcDate': '2009-06-03', 'lastUpdatePostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-06-03', 'studyFirstPostDateStruct': {'date': '2009-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours', 'timeFrame': '4 weeks', 'description': 'Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)'}, {'measure': 'Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours', 'timeFrame': '4 weeks', 'description': 'Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be adult males or females 18 to 60 years old\n* Subjects must be able and willing to follow study procedures and instructions\n* Subjects must have generalized, moderate plaque-associated gingivitis as determined by the Investigator or designee during the screening examination\n* Subjects must present with at least 20 teeth in the functional dentition, excluding third molars\n* Each subject must have at least four teeth with probing depths of 4-5 millimeters and at least 30% of sites bleeding to gentle probing\n\nExclusion Criteria:\n\n* Subjects who have chronically used (two weeks or more) Total (Triclosan/Copolymer) dentifrice within 6 months prior to enrollment\n* Subjects with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity\n* Subjects with periodontitis as indicated by periodontal pocketing 6 millimeters at screening\n* Subjects with a history of early onset periodontitis or acute necrotizing ulcerative gingivitis\n* Subjects with concomitant endodontic or periodontal therapy other than prophylaxis within 6 months prior to enrollment\n* Subjects with orthodontic appliances or removable partial dentures\n* Subjects chronically treated (two weeks or more) with any medication known to affect inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs, steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within one month of the screening examination. All other medications for chronic medical conditions should be initiated at least three months prior to enrollment\n* Subjects who currently smoke or who report using tobacco products within one year of screening.\n* Subjects who have been treated with antibiotics for medical or dental reasons within 3 months prior to enrollment\n* Subjects having clinically significant or unstable organic disease; subjects having compromised healing potential such as those with diabetes mellitus or connective tissue disorders; subjects having heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis\n* Female subjects who report being pregnant\n* Subjects who use hormonal contraceptives must have started the method 30 days prior to the screening examination.\n* Subjects with active infectious diseases such as hepatitis, human immunodeficiency virus or Tuberculosis\n* Subjects diagnosed with human immunodeficiency virus (HIV) or subjects that are immunocompromised as determined by the Investigator\n* Medical condition which precludes not eating/drinking for approximately 8 hours.'}, 'identificationModule': {'nctId': 'NCT00941668', 'briefTitle': 'Evaluate Inflammation Caused by Gingivitis in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'Evaluate Inflammation Caused by Gingivitis in Adults', 'orgStudyIdInfo': {'id': 'CRO-1005-INF-UNC-FP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Total Toothpaste', 'description': 'Triclosan/Copolymer/fluoride toothpaste', 'interventionNames': ['Drug: Triclosan/Copolymer/fluoride toothpaste']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Fluoride toothpaste', 'description': 'sodium monofluorophosphate toothpaste', 'interventionNames': ['Drug: sodium monofluorophosphate toothpaste']}], 'interventions': [{'name': 'Triclosan/Copolymer/fluoride toothpaste', 'type': 'DRUG', 'otherNames': ['Total toothpaste'], 'description': 'Twice daily usage', 'armGroupLabels': ['Total Toothpaste']}, {'name': 'sodium monofluorophosphate toothpaste', 'type': 'DRUG', 'otherNames': ['Colgate cavity protection toothpaste'], 'description': 'Twice daily usage', 'armGroupLabels': ['Fluoride toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'David Paquette, DMD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}