[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624787":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":26,"overallStatus":38,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Colgate Palmolive","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test Group","ACTIVE_COMPARATOR","Subjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds.",[13],"Other: Test Mouthrinse",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","PLACEBO_COMPARATOR","subjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds.",[19],"Other: Control Mouthrinse",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"OTHER","Test Mouthrinse","Test Mouthrinse: 0.0553% NaF (250 ppm Fluoride), Amine and 0.2% Zinc Lactate dihydrate",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Control Mouthrinse","Control Mouthrinse: 0.0553% NaF(250 ppm Fluoride)",[15],[32],{"name":33,"affiliation":34,"role":35},"Eva-Maria Axmann","SGS proderm GmbH","PRINCIPAL_INVESTIGATOR",[37],{"facility":34,"status":38,"city":39,"state":26,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Schenefeld","22869","Germany","DE",{"type":44,"coordinates":45},"Point",[46,47],9.48146,54.04644,{"lat":47,"lon":46},[50],{"name":51,"role":52,"phone":53,"phoneExt":26,"email":54},"Arti T Nurrisyanti, MSc","CONTACT","+49 40 839 358 0","arti.Nurrisyanti@sgs.com",{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100624787","phase-4-6-month-clinical-investigation-assessing-the-efficacy-of-an-antimicrobial-mouthrinse-in-reducing-established-plaque-and-improving-gum-health-100624787",false,"NCT07414173","6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health","Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and the Improvement of Gum Health: a 6-month Clinical Study","Inclusion Criteria:\n\n1. Male and female subjects aged 18-70 years, inclusive.\n2. Availability for the 6-month duration of the clinical research study.\n3. Good general health based on the opinion of the study investigator.\n4. Signed Informed Consent Form.\n5. Minimum of 20 natural teeth (excluding third molars).\n6. Initial gingivitis index of at least 1.5 as determined by the use of the Loe and Silness Gingival Index.\n7. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).\n\nExclusion Criteria:\n\n1. Be under orthodontic treatment.\n2. Presence of partial removable dentures.\n3. Tumor(s) of the soft or hard tissues of the oral cavity.\n4. Participants with current moderate or severe periodontitis (periodontitis screening index \\[PSI\\] \\>2 in more than 2 sextants or PSI \\>3), and\u002For purulent exudate, tooth mobility, and\u002For extensive loss of periodontal attachment or alveolar bone.\n5. Five or more carious lesions requiring immediate restorative treatment.\n6. Antibiotic use any time during the one-month period prior to entry into the study.\n7. Participation in any other clinical study or test panel within the one month prior to entry into the study.\n8. Dental prophylaxis during the past two weeks prior to baseline examinations.\n9. History of allergies to oral care\u002Fpersonal care consumer products or their ingredients.\n10. On any prescription medicines that might interfere with the study outcome based on the examiner\u002FPI opinion.\n11. An existing medical condition that prohibits eating and\u002For drinking for periods up to 4 hours.\n12. History of alcohol and\u002For drug abuse.\n13. Self-reported pregnancy and\u002For lactating subjects.\n14. Subjects with other oral diseases (including gingival hyperplasia, diseases of the oral mucosa), or any condition that the dental examiner considers exclusionary from the study.\n15. Smokers or\u002Fand users of tobacco products.\n16. Enrolled in an undergraduate, postgraduate, or academic dentistry program",true,"ALL","18 Years","70 Years",{"count":69,"type":70},90,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","The goal of this clinical trial is to evaluate the clinical efficacy of an antimicrobial mouthrinse, with a particular focus on its effect on established plaque and the improvement of gum health.\n\nParticipants will:\n\n* Brush and rinse twice a day with the designated products for 6 months\n* Visit the clinic once every 3 months after baseline for reassessment.",[76,77],"Gingivitis","Dental Plaque Accumulation","2026-02-10",{"date":80,"type":81},"2026-02-17","ACTUAL",{"date":83,"type":81},"2026-01-28",{"date":85,"type":70},"2026-11",{"name":5,"class":6},1]