[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494715":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":133,"collaborators":19,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":143,"sex":144,"minAge":145,"maxAge":19,"enrollmentInfo":146,"targetDuration":19,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":156,"overallStatus":62,"whyStopped":19,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants receiving a dental cleaning and oral hygiene instruction","EXPERIMENTAL","Participants randomized to this arm will receive a standard dental cleaning and education on proper toothbrushing and flossing technique and asked to follow these toothbrushing and flossing techniques for the duration of the study period. They will receive periodic phone call reminders to maintain these practices during the study period.",[13,14],"Behavioral: Oral Hygiene instruction","Procedure: Dental Cleaning",{"label":16,"type":17,"description":18,"interventionNames":19},"Control","NO_INTERVENTION","Participants randomized to this arm will be instructed to continue with their usual oral hygiene practices for the duration of the study period.",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"BEHAVIORAL","Oral Hygiene instruction","Participants will be instructed on the Modified Bass technique for toothbrushing: brushing with a soft bristled toothbrush held at a 45 degree angle to the gums and brushed in a circular motion. Participants will also be instructed to floss at least once per day using floss or another inter-dental device (e.g., floss pick).",[9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":19},"PROCEDURE","Dental Cleaning","Participants will receive a dental cleaning according to the current standard of care for routine dental cleanings.",[9],[32],{"name":33,"affiliation":5,"role":34},"Peter Lockhart, DDS","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":19,"email":40},"Cathy Petersen, RDH","CONTACT","704-355-1494","cathleen.petersen@atriumhealth.org",{"name":42,"role":38,"phone":43,"phoneExt":19,"email":44},"Kate Sullivan, MA","704-355-9496","kathleen.sullivan@atriumhealth.org",[46,60,77,88,108,118],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":19},"Tufts University School of Dental Medicine and Tufts University Health Sciences Campus","WITHDRAWN","Boston","Massachusetts","02111","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-71.05977,42.35843,{"lat":58,"lon":57},{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":52,"countryCode":53,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"University of Michigan School of Dentistry and Michigan Medicine","RECRUITING","Ann Arbor","Michigan","48109",{"type":55,"coordinates":67},[68,69],-83.74088,42.27756,{"lat":69,"lon":68},[72,75],{"name":73,"role":38,"phone":19,"phoneExt":19,"email":74},"Mary Burton","mjburt@med.umich.edu",{"name":76,"role":34,"phone":19,"phoneExt":19,"email":19},"Stephanie Munz, DDS",{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":52,"countryCode":53,"cosmosGeoPoint":83,"geoPoint":87,"contacts":19},"Rutgers School of Dental Medicine","COMPLETED","Newark","New Jersey","07103",{"type":55,"coordinates":84},[85,86],-74.17237,40.73566,{"lat":86,"lon":85},{"facility":89,"status":90,"city":91,"state":91,"zip":92,"country":52,"countryCode":53,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"New York University","NOT_YET_RECRUITING","New York","10010",{"type":55,"coordinates":94},[95,96],-74.00597,40.71427,{"lat":96,"lon":95},[99,103,106],{"name":100,"role":38,"phone":101,"phoneExt":19,"email":102},"Leticia Arbex","212-998-9800","la1669@nyu.edu",{"name":104,"role":38,"phone":19,"phoneExt":19,"email":105},"Mariana Bucovsky","mb10357@nyu.edu",{"name":107,"role":34,"phone":19,"phoneExt":19,"email":19},"Payam Mirfendereski",{"facility":109,"status":110,"city":111,"state":91,"zip":112,"country":52,"countryCode":53,"cosmosGeoPoint":113,"geoPoint":117,"contacts":19},"University of Rochester Medical Center","ACTIVE_NOT_RECRUITING","Rochester","14620",{"type":55,"coordinates":114},[115,116],-77.61556,43.15478,{"lat":116,"lon":115},{"facility":119,"status":62,"city":120,"state":121,"zip":122,"country":52,"countryCode":53,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Atrium Health's Carolinas Medical Center","Charlotte","North Carolina","28203",{"type":55,"coordinates":124},[125,126],-80.84313,35.22709,{"lat":126,"lon":125},[129,131],{"name":130,"role":38,"phone":39,"phoneExt":19,"email":40},"Cathleen Petersen, RDH",{"name":132,"role":34,"phone":19,"phoneExt":19,"email":19},"Joel J Napenas, DDS",{"type":134,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100494715","reducing-risk-for-infective-endocarditis-100494715",false,"NCT05721781","Reducing Risk for Infective Endocarditis","Reducing Risk for Infective Endocarditis (IE): A Randomized Trial of a Professional Scaling and Oral Hygiene Instruction Intervention to Reduce Tooth Brushing-Associated Bacteremia","PIE-B","Inclusion Criteria:\n\n* Age 18 years or older.\n* Greater than 6 months since last dental hygiene prophylaxis (cleaning).\n* 10 or more accessible teeth (including implants, with a minimum of 8 natural teeth).\n* Willing and able to provide informed consent.\n* Willing to comply with all study procedures and be available for the duration of the study.\n* Willing to forgo routine professional dental cleanings while enrolled in the trial.\n\nExclusion Criteria:\n\n* At high risk for IE, as defined by the 2007\u002F2021 AHA Guidelines:\n* Prosthetic cardiac valve or prosthetic material used for cardiac valve repair.\n* Previous episode of IE.\n* Cardiac transplantation recipient with cardiac valvulopathy.\n* Specific congenital heart disease conditions.\n* Pregnant, by self-report, or planning to become pregnant during the study period.\n* Affected by a condition that, in the opinion of the investigator, may preclude them from study completion or put them at increased risk such as :\n* Hemodialysis dependent.\n* Have a long-term intravascular catheter (e.g., for chemotherapy or parenteral nutrition).\n* Active injection drug use (IDU).\n* Clotting disorder such as, hemophilia.\n* Have a solid organ transplant or hematopoietic stem cell transplant, or ongoing treatment for hematologic cancer.\n* Currently incarcerated.\n* Systemic antibiotic use within the past 2 weeks.\n* Undergoing orthodontic treatment with fixed appliances (brackets and wires) or plans to do so during the study period.\n* Taking or requiring antibiotic prophylaxis prior to dental procedures for other reasons, e.g., to prevent prosthetic joint infection .\n* Three or more teeth with moderate to severe gingival hyperplasia.\n* Has clinically detectable emergent or urgent dental needs that, in the trained and calibrated Oral Examiner's opinion, would require definitive dental care during the study period.",true,"ALL","18 Years",{"count":147,"type":148},320,"ESTIMATED","INTERVENTIONAL",[151],"NA","This clinical trial is studying if bacteria found in a participant's bloodstream after brushing their teeth can be prevented with a dental cleaning and more education on how to best brush and care for their teeth. One group of participants will have a dental cleaning and oral health instructions and the other group of participants will not. Researchers will compare the blood test results from the two groups to see if the education made a difference in preventing bacteria and how long it stays in the bloodstream.",[154,155],"Bacteremia","Infective Endocarditis",[157,158,159],"Oral Hygiene","Oral Bacteria","Gingival inflammation","2025-08-21",{"date":162,"type":163},"2025-08-22","ACTUAL",{"date":165,"type":163},"2023-08-31",{"date":167,"type":148},"2027-09",{"name":5,"class":6},6]