[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640564":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":50,"collaborators":11,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":11,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Colgate Palmolive","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Brushing with sodium fluoride toothpaste","OTHER",null,[13],"Drug: sodium monofluorophosphate toothpaste",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","sodium monofluorophosphate toothpaste","All subjects will receive the same treatment for standardization",[9],[21],{"name":22,"affiliation":5,"role":23},"Gabriella John, MS","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Jeffery Milleman, DDS, MPA","CONTACT","260-755-1099","milleman@salusresearch.us",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Salus Research, Inc.","RECRUITING","Fort Wayne","Indiana","46825","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-85.12886,41.1306,{"lat":43,"lon":42},[46,48],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":47},"Milleman@salusresearch.us",{"name":26,"role":49,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100640564","phase-4-clinical-study-to-collect-and-analyze-dental-plaque-and-oral-health-measures-in-a-population-with-high-plaquelow-gingivitis-and-high-plaquehigh-gingivitis-100640564",false,"NCT07614490","Clinical Study to Collect and Analyze Dental Plaque and Oral Health Measures in a Population With High Plaque\u002FLow Gingivitis and High Plaque\u002FHigh Gingivitis","Inclusion Criteria:\n\n* Male or female volunteers at least 18 years of age and in general good health.\n* Willing and able to understand and sign the informed consent form.\n* Must have a whole mouth mean TPI score ≥ 3.25\n* N=40 must have moderate-severe gingivitis (Whole Mouth Mean MGI≥2.5 or percent bleeding sites based on EBI ≥20%) and N=40 must have mild gingivitis (Whole Mouth Mean MGI≤2.5 and percent bleeding sites based on EBI\\\u003C20%)\n* Must have at least two areas in the mouth with high plaque\u002Flow inflammation and two areas with high plaque\u002Fhigh inflammation\n* Be willing to conform to the study protocol and procedures.\n* Minimum of 20 natural teeth with scorable facial and lingual surfaces\n\nExclusion Criteria:\n\n* Medical condition which requires premedication prior to dental visits\u002Fprocedure.\n* Known history of allergy to personal care\u002Fconsumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.\n* Active disease of the hard oral tissues.\n* Significant oral soft tissue pathology, excluding plaque-induced gingivitis.\n* Subjects with fixed or removable orthodontic appliances or removable partial dentures.\n* Dental prophylaxis within 30 days prior to study start.\n* Use of antibiotics, antimicrobial drugs, anti-inflammatory drugs, or anticoagulant therapies within 30 days prior to study start.\n* Use of chemotherapeutic oral care products within two weeks prior to study start.\n* Participation in any other clinical study within 30 days prior to enrollment into this study.\n* Subjects who must receive dental treatment during the study dates.\n* Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).\n* Use of smokeless tobacco, vaping, or e-cigarettes or suspected substance abuse.\n* Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1)\n* Pregnant or lactating subjects, or subjects planning to become pregnant during the course of the study.\n* Medical condition which prohibits not eating\u002Fdrinking or chewing gum for four (4) hours prior to your scheduled visits;\n* Subjects who have an infectious disease and\u002For other blood borne diseases (Hepatitis series, HIV, tuberculosis).","ALL","18 Years",{"count":61,"type":62},100,"ESTIMATED","INTERVENTIONAL",[65],"PHASE4","The objective of this clinical research study is to collect and analyze plaque and oral health measures in a population with high plaque\u002Flow gingivitis and high plaque\u002Fhigh gingivitis",[68,69],"Gingivitis","Plaque","2026-05-22",{"date":72,"type":73},"2026-05-29","ACTUAL",{"date":75,"type":73},"2026-04-20",{"date":77,"type":62},"2026-10-15",{"name":5,"class":6},1]