[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100338941":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":26,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":96,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Primal Therapies Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PTx800","EXPERIMENTAL","Qualified subjects will dissolve one oral lozenge (PTx800 lozenges) by mouth 3 times a day (after breakfast, lunch and dinner) throughout the 6 week study.",[13],"Dietary Supplement: PTx800 lozenges",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Qualified subjects will dissolve one oral lozenge (placebo control) by mouth 3 times a day (after breakfast, lunch and dinner) throughout the 6 week study.",[19],"Dietary Supplement: Placebo control",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","PTx800 lozenges","PTX800 is a nutritional supplement containing generally recognized as safe designated active ingredients in a rapid melt oral lozenges.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo control","The placebo of PTX800 is a rapid melt oral lozenge without the active ingredients found in the PTX800 lozenges.",[15],[32],{"name":33,"affiliation":34,"role":35},"Emily Stein","Primal Therapies","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Emily Stein, PhD","CONTACT","510-847-8132","emily.stein@primaltx.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Farida Ejaz, PhD","216-373-16600","fejaz@benrose.org",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Benjamin Rose Institute on Aging","RECRUITING","Cleveland","Ohio","44120","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-81.69541,41.4995,{"lat":59,"lon":58},[62],{"name":63,"role":39,"phone":64,"phoneExt":26,"email":65},"Jenna Lovasz, BS","216-373-1771","jlovasz@benrose.org",{"type":67,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[69],{"name":48,"class":70},"OTHER","100338941","evaluation-of-a-daily-oral-care-lozenge-on-oral-health-and-quality-of-life-in-older-adults-100338941",false,"NCT03693027","Evaluation of a Daily Oral Care Lozenge on Oral Health and Quality of Life in Older Adults","Inclusion Criteria:\n\n* age range between 60 and 85 years,\n* non-smokers or those who have stopped for 2 years or more,\n* baseline gingival index (MGI score greater or equal to 1.75),\n* score of 4 or lower on the Short Portable Mental Status Questionnaire (SPMSQ).\n\nExclusion Criteria:\n\n* subjects on antibiotic within the previous 30 days,\n* fixed or removable full dentures,\n* advanced periodontitis,\n* significant oral soft tissue pathology based on a visual examination (excluding gingivitis),\n* gross dental caries,\n* score of 5 or higher on the Short Portable Mental Status Questionnaire (SPMSQ).",true,"ALL","60 Years","85 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"NA","The assessment of a daily oral care lozenge (PTx800) will be compared to a placebo control in a cohort of older adults who visit adult senior centers and who also have mild to moderate gingivitis. The comparison of the pre-to post change in gum health and pathogen burdens will be measured over a 6 week period. In addition, the feasibility and acceptability of using the lozenges will be assessed in this older adult population.",[89],"Oral Health",[91,92,93,94,95],"Older adults","microbiome","gum health","gingivitis","gum disease","UNKNOWN","2018-10-04",{"date":99,"type":100},"2018-10-09","ACTUAL",{"date":102,"type":100},"2018-06-01",{"date":104,"type":83},"2018-12-31",{"name":5,"class":6},1]