[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657601":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":16,"studyPopulation":16,"armGroups":28,"interventions":44,"overallOfficials":57,"centralContacts":62,"locations":71,"responsibleParty":84,"collaborators":16,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":16,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":16,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":108,"whyStopped":16,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Colgate Palmolive","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Gingivitis Assessment","A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror.\n\nA whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored.\n\n0 = Absence of inflammation\n\n1. = Mild inflammation - slight change in color and little change in texture\n2. = Moderate inflammation - moderate glazing, redness, edema and hypertrophy\n3. = Severe inflammation - marked redness and hypertrophy. Tendency for spontaneous bleeding\n\nEach tooth is scored on six surfaces: mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. The maximum score per tooth, therefore, is 18.","Baseline, 3 month, 6 month",{"measure":14,"description":15,"timeFrame":12},"Quigley-Hein Plaque Index","First using a red solution to dye the plaque, a Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":22,"maskingDescription":16,"whoMasked":23},"QUADRUPLE",[24,25,26,27],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[29,35,40],{"label":30,"type":31,"description":32,"interventionNames":33},"Test 1 toothpaste","EXPERIMENTAL","Subjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily.",[34],"Drug: Silica Free Meridol",{"label":36,"type":37,"description":32,"interventionNames":38},"Test 2 toothpaste","ACTIVE_COMPARATOR",[39],"Drug: Meridol",{"label":41,"type":37,"description":32,"interventionNames":42},"Test 3 toothpaste",[43],"Drug: Colgate Dental Product",[45,50,53],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":16},"DRUG","Silica Free Meridol","Toothpaste",[30],{"type":46,"name":51,"description":48,"armGroupLabels":52,"otherNames":16},"Meridol",[36],{"type":46,"name":54,"description":55,"armGroupLabels":56,"otherNames":16},"Colgate Dental Product","MFP fluoride toothpaste",[41],[58],{"name":59,"affiliation":60,"role":61},"Deyu Hu, DDS, MS","West China Dental Institute of Chengdu","PRINCIPAL_INVESTIGATOR",[63,67],{"name":59,"role":64,"phone":65,"phoneExt":16,"email":66},"CONTACT","86-1390-803-4990","hudeyu@vip.sina.com",{"name":68,"role":64,"phone":69,"phoneExt":16,"email":70},"Yisi Zhong, DDS, PhD","86-1388-228-6537","zhongyisi@scu.edu.cn",[72],{"facility":60,"status":16,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":16},"Chengdu","Sichuan","610041","China","CN",{"type":79,"coordinates":80},"Point",[81,82],104.06667,30.66667,{"lat":82,"lon":81},{"type":85,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100657601","phase-3-clinical-study-examining-the-control-of-plaque-and-gingivitis-100657601",false,"NCT07842978","Clinical Study Examining the Control of Plaque and Gingivitis","A Six-month Clinical Investigation of a Silica-free Meridol Toothpaste Versus Colgate Cavity Protection Toothpaste for the Control of Established Dental Plaque and Gingivitis","Inclusion Criteria:\n\n* Subjects, ages 18-70, inclusive.\n* Availability for the six-month duration of the clinical research study.\n* Good general health.\n* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).\n* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.\n* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).\n* Signed Informed Consent Form\n\nExclusion Criteria:\n\n* Presence of orthodontic bands.\n* Presence of partial removable dentures.\n* Tumor(s) of the soft or hard tissues of the oral cavity.\n* Advanced periodontal disease (purulent exudate, tooth mobility, and\u002For extensive loss of periodontal attachment or alveolar bone).\n* Five or more carious lesions requiring immediate restorative treatment.\n* Antibiotic use any time during the one month prior to entry into the study.\n* Participation in any other clinical study or test panel within the one month prior to entry into the study.\n* Dental prophylaxis during the past two weeks prior to baseline examinations.\n* History of allergies to oral care\u002Fpersonal care consumer products or their ingredients.\n* On any prescription medicines that might interfere with the study outcome.\n* An existing medical condition which prohibits eating or drinking for periods up to 4 hours.",true,"ALL","18 Years","70 Years",{"count":98,"type":99},135,"ESTIMATED","INTERVENTIONAL",[102],"PHASE3","The objective of this six-month clinical investigation is to evaluate the efficacy of a silica-free meridol toothpaste versus Colgate Cavity Protection Toothpaste in the control of established dental plaque and gingivitis.",[105],"Gingivitis",[107],"plaque","NOT_YET_RECRUITING","2026-09-21",{"date":111,"type":112},"2026-09-25","ACTUAL",{"date":114,"type":99},"2026-10",{"date":116,"type":99},"2027-04",{"name":5,"class":6},1]