[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655046":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":43,"studyPopulation":16,"armGroups":44,"interventions":61,"overallOfficials":16,"centralContacts":16,"locations":16,"responsibleParty":93,"collaborators":95,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":16,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":109,"maxAge":16,"enrollmentInfo":110,"targetDuration":16,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":130,"whyStopped":16,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":16},{"fullName":5,"class":6},"Colgate Palmolive","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of pneumonia","Incidence of pneumonia acquired during the study","1 year",[14,18,21,25,29,33],{"measure":15,"description":16,"timeFrame":17},"Diabetes status",null,"every 3 months for 1 year",{"measure":19,"description":16,"timeFrame":20},"HbA1c value","Every 3 months for 1 year",{"measure":22,"description":23,"timeFrame":24},"Oral Health History","Significant history of oral health","Baseline",{"measure":26,"description":27,"timeFrame":28},"Oral Health Status","This includes plaque, calculus, stain, visible inflammation, and oral hygiene status","Monthly for one year",{"measure":30,"description":31,"timeFrame":32},"Level of adherence to oral hygiene regimen","This is a measure of how adherent the nursing home staff was in completing each instance of oral hygiene regimens for the subjects.","Monthly for 1 year",{"measure":34,"description":35,"timeFrame":12},"Satisfaction with program","This will be captured via surveys for the subjects, facility staff, and facility leadership at different times throughout the study.",{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":16,"timePerspective":16,"maskingInfo":41},"NON_RANDOMIZED","PARALLEL","There will be two cohorts in this study. Each cohort has a number of products from which the dentist and hygienist can choose for each patient.","TREATMENT",{"masking":42,"maskingDescription":16,"whoMasked":16},"NONE","This study will be completed in partnership with the Missouri Department of Health and Senior Services, McCoy Samples Mattingly Dental Clinic, and Feno, inc. The study involves a nursing home staff training program, product intervention, and oral health outcomes.",[45,55],{"label":46,"type":47,"description":48,"interventionNames":49},"Cohort A","EXPERIMENTAL","Subjects in this arm of the trial will use a manual or power toothbrush, OTC and\u002For Rx toothpaste, and OTC and\u002For Rx mouthwash.",[50,51,52,53,54],"Drug: Stannous Fluoride Toothpaste (SnF)","Drug: sodium fluoride 5000 ppm","Drug: cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash","Drug: sodium fluoride Mouthwash","Drug: Chlorhexidine 0,12%",{"label":56,"type":47,"description":57,"interventionNames":58},"Cohort B","Subjects in this arm of the trial will use a smart toothbrush, a cosmetic toothpaste, and an OTC and\u002For Rx mouthwash.",[53,54,59,60],"Device: connected toothbrush","Other: xylitol toothpaste",[62,67,71,75,79,83,88],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":16},"DRUG","Stannous Fluoride Toothpaste (SnF)","Cohort A will use a stannous fluoride toothpaste",[46],{"type":63,"name":68,"description":69,"armGroupLabels":70,"otherNames":16},"sodium fluoride 5000 ppm","Cohort A will have the option of using a sodium fluoride 5000 ppm toothpaste if prescribed by the dentist.",[46],{"type":63,"name":72,"description":73,"armGroupLabels":74,"otherNames":16},"cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash","Cohort A will use an antiplaque\u002Fantigingivitis mouthwash",[46],{"type":63,"name":76,"description":77,"armGroupLabels":78,"otherNames":16},"sodium fluoride Mouthwash","Cohort A and Cohort B may use the sodium fluoride OTC mouthwash",[46,56],{"type":63,"name":80,"description":81,"armGroupLabels":82,"otherNames":16},"Chlorhexidine 0,12%","Cohort A and Cohort B may use a 0.12% chlorhexidine alcohol free mouthwash",[46,56],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":16},"DEVICE","connected toothbrush","Cohort B will use a u-shaped connected \"smart\" toothbrush",[56],{"type":89,"name":90,"description":91,"armGroupLabels":92,"otherNames":16},"OTHER","xylitol toothpaste","Cohort B will use a xylitol toothpaste",[56],{"type":94,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR",[96,99],{"name":97,"class":98},"McCoy Samples Mattingly Dental Clinic","UNKNOWN",{"name":100,"class":98},"FENO.Co","100655046","phase-4-oral-hygiene-assistance-training-program-100655046",false,"NCT07807397","Oral Hygiene Assistance Training Program","Inclusion Criteria:\n\n* Signed Informed Consent Form to receive on-site dental care and grant access to their medical and dental records, and Consent for information collection, consultation, and disease control oral healthcare treatment\n* Male and female subjects aged 60 years or older.\n* A resident of one of the nursing home sites.\n* ASA physical classification status of II, III, or IV (excluding high frailty scores)\n* Frailty assessment of low or moderate\n\nExclusion Criteria:\n\n* Tumor(s) of the soft or hard tissues of the oral cavity.\n* History of allergies to oral care\u002Fpersonal care consumer products or their ingredients.\n* ASA category V patients\n* High frailty assessment\n* Resident deemed behaviorally difficult in interview or initial assessment\n* Endentulous\n* Fractured teeth and\u002For root tips present\n* Oral lesions\n* Grossly mobile teeth for Cohort B\n* Temporary crowns for Cohort B",true,"ALL","60 Years",{"count":111,"type":112},500,"ESTIMATED","INTERVENTIONAL",[115],"PHASE4","This is an oral health study with a nursing home staff training program and product intervention.",[118,119,120,121],"Elderly","Periodontal Disease","Gingivitis","Caries,Dental",[123,120,124,125,119,126,127,128,129,118],"Caries","Nursing Home","Pneumonia","Behavior Change","toothbrushing","mouthwash","toothpaste","NOT_YET_RECRUITING","2026-09-02",{"date":133,"type":134},"2026-09-08","ACTUAL",{"date":136,"type":112},"2026-09-20",{"date":138,"type":112},"2027-09",{"name":5,"class":6}]