[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609367":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":65,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":42,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":42,"enrollmentInfo":81,"targetDuration":42,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":50,"whyStopped":42,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Case Western Reserve University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"A \"simple medical strategy\" consisting of SDF","EXPERIMENTAL","This treatment will be a bi-annual application of 38% silver diamine (Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) solution to new ICDAS lesions code 3-6 (at baseline and 26-weeks or 26-weeks and 52 weeks) following manufacturers instructions and guidelines published by UCSF (2016).",[13],"Device: A \"simple medical strategy\" consisting of silver diamine fluoride (SDF)",{"label":15,"type":16,"description":17,"interventionNames":18},"A \"typical dental strategy\" consisting of ART + FV","ACTIVE_COMPARATOR","Atraumatic Restorative Treatment (ART) will be a modification of the approach used by Lo and colleagues (2006),2 and the cavity restored at baseline with resin reinforced glass-ionomer cement (GIC) (GC Corporation, Japan).\n\nParticipants in this arm will also receive biannual topical fluoride varnish application (FluoriMax, Elevate) according to manufacturer's instructions.",[19],"Device: A \"typical dental strategy\" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride Varnish (FV)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","A \"simple medical strategy\" consisting of silver diamine fluoride (SDF)","Bi-annual topical application of 38% silver diamine solution to new ICDAS lesions code 3-6. Advantage Arrest, Elevate Oral Care, West Palm Beach FL",[9],[27],"SDF Treatment",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"A \"typical dental strategy\" consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride Varnish (FV)","GC Fuji (for ART) and FluoriMax Varnish. Atraumatic Restoration Treatment (ART) to new ICDAS lesions code 3-6, followed by bi-annual topical fluoride varnish (FV) to all teeth.",[15],[33],"ART + FV Treatment",[35],{"name":36,"affiliation":5,"role":37},"Suchitra S Nelson, PhD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","216-368-3469",null,"sxn15@case.edu",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Shelley Curtan, MEd","216-368-3968","sgc36@case.edu",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Cleveland","Ohio","44106","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-81.69541,41.4995,{"lat":60,"lon":59},[63,64],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},{"name":36,"role":37,"phone":42,"phoneExt":42,"email":42},{"type":37,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Suchitra Nelson","Associate Dean of Clinical and Translational Research Professor and Interim Chair, Community Dentistry",[69],{"name":70,"class":6},"Patient-Centered Outcomes Research Institute","100609367","lt-comparative-effectiveness-of-2-caries-treatments-100609367",false,"NCT07213661","LT Comparative Effectiveness of 2 Caries Treatments","Long-term Comparative Effectiveness of 2 Treatments to Arrest Dental Caries in Older Adults","Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Were participants in the original study from the 33 housing sites\n* Provide signed and dated long-term follow-up informed consent form\n* Willingness to stay in the LTFU study for 1 year\n* Additionally for focus groups, completed the treatment phase of the study\n\nExclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Sensitivity to silver or other heavy-metal ions\n* Serious life-threatening medical disease\n* Additionally, any participant with the presence of gingival\u002Fperioral ulceration or stomatitis or tooth abscess in any specific tooth will be referred to a dentist but can only be enrolled after resolution",true,"ALL","62 Years",{"count":82,"type":83},480,"ESTIMATED","INTERVENTIONAL",[86],"NA","This study is a continuation of a cluster randomized clinical trial (cRCT) conducted in 33 publicly subsidized housing facilities\u002Fsites (HUD Section 202) and other low-income housing voucher programs in NE Ohio. The Intervention Arm (18 sites) - participants received biannual silver diamine fluoride (SDF) versus the Control Arm (15 sites) where participants received atraumatic restorative treatment (ART) with glass ionomer cement (GIC) + biannual fluoride varnish (FV) application. A total of 568 participants were recruited in the original study, and 480 participants (Intervention Arm: 287, Control Arm: 193) are expected to continue in this long-term follow-up study. Since enrollment in the original study was done over time, each participant will contribute data at 3 to 6 years (from randomization) in the LTFU depending on study entry to assess clinical equipoise of the two treatments.\n\nCommunity-dwelling older adults, regardless of medical, cognitive, or motor impairments, were considered for inclusion in the original study and were: (1) aged ≥ 62 years in the 33 housing facilities; (2) have at least one untreated active root or coronal carious lesion with ICDAS-II lesion severity code of 3 or greater ; (3) willingness to stay in the study for 1 year. Exclusion criteria: (1) sensitivity to silver or other heavy-metal ions; (2) serious life-threatening medical disease. Additionally, any participant with the presence of gingival\u002Fperioral ulceration or stomatitis or tooth abscess in any specific tooth were referred to a dentist and enrolled after resolution. The LTFU study will follow the same enrolled participants long-term. The current mean (sd) age of the 480 participants who will enter the LTFU study will be 73.73 (6.92) years.",[89],"Dental Caries",[89,91,92],"Oral Health Quality of Life","Tooth Loss","2025-11-12",{"date":95,"type":96},"2025-11-13","ACTUAL",{"date":98,"type":96},"2025-10-08",{"date":100,"type":83},"2030-01",{"name":5,"class":6},1]