[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658832":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":30,"interventions":39,"overallOfficials":20,"centralContacts":45,"locations":51,"responsibleParty":69,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":20,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":20,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":53,"whyStopped":20,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Michigan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Number of new caries surfaces and number of progressed caries surfaces","Composite Endpoint. New caries surface defined as baseline was sound (ICDAS=0 and no filling) and follow-up was enamel or dentin decay (ICDAS≥1), filling, or extracted due to caries. Caries progression defined if baseline was enamel decay and follow-up was dentin decay, filling, or extracted due to caries.","12 Months",[14,17,19],{"measure":15,"description":16,"timeFrame":12},"Number of new caries surfaces","New caries surface defined as baseline was sound (ICDAS=0 and no filling) and follow-up was enamel or dentin decay (ICDAS≥1), filling, or extracted due to caries.",{"measure":10,"description":11,"timeFrame":18},"6 Months",{"measure":15,"description":16,"timeFrame":18},null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":26,"maskingDescription":27,"whoMasked":28},"SINGLE","The statistician will remain blinded during analyses.",[29],"OUTCOMES_ASSESSOR",[31,34],{"label":32,"type":33,"description":20,"interventionNames":20},"Manual Toothbrush","NO_INTERVENTION",{"label":35,"type":36,"description":20,"interventionNames":37},"Powered Toothbrush","EXPERIMENTAL",[38],"Device: Powered toothbrush",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":20},"DEVICE","Powered toothbrush","Powered toothbrush Oral-B iO Kids Electric Toothbrush Featuring Stitch",[35],[46],{"name":47,"role":48,"phone":49,"phoneExt":20,"email":50},"Taylor Cezon, RDH","CONTACT","734-730-8533","kidscavities@umich.edu",[52],{"facility":5,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-83.74088,42.27756,{"lat":63,"lon":62},[66],{"name":67,"role":68,"phone":20,"phoneExt":20,"email":20},"Margherita Fontana, DDS, PhD","PRINCIPAL_INVESTIGATOR",{"type":68,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Margherita Fontana","Professor, DDS, PhD",[73],{"name":74,"class":75},"Procter and Gamble","INDUSTRY","100658832","powered-vs-manual-toothbrush-use-its-effect-on-caries-risk-in-pre-adolescents-a-pilot-study-100658832",false,"NCT07859553","Powered vs Manual Toothbrush Use: Its Effect on Caries Risk in Pre-Adolescents","Powered vs Manual Toothbrush Use: Its Effect on Caries Risk in Pre-Adolescents, A Pilot Study","Inclusion Criteria:\n\n* Child:\n\n  * Male OR Female, between 8 - 12 years old at baseline\n  * In good health (i.e., free of any medical condition that would reasonably be anticipated to interfere with study participation)\n  * Must allow examination of the oral cavity at baseline\n  * Must have at least an ICDAS 2 or higher at baseline or radiographic signs of untreated caries lesions E2 or higher, or caries experience in the last 3 years (extraction due to caries, restoration due to caries, etc.)\n  * Able to tolerate radiographs\n  * Able to brush teeth by themselves with no assistance\n\nParent\u002FLegal Guardian:\n\n* Provide written informed consent for the child and her\u002Fhimself prior to participation\n* Must be at least 18 years old, or an emancipated minor who provides documentation of emancipation\n* Must be willing and able to participate in study activities\n\nExclusion Criteria:\n\n* Child:\n\n  * Hereditary generalized developmental dental defects such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta\n  * Presence of pain, pulpal exposure, or signs of pulpal infection (abscess, fistula, swelling) at baseline\n  * Participating in the foster care system\n  * Demonstrated inability to comply with study protocol requirements (including radiographs or abstaining from using other oral hygiene products such as mouth rinses during the study period)\n  * Has removable OR fixed orthodontic appliances\n  * Participation (within 30 days of Baseline Visit) in any other oral hygiene clinical study\n\nParent\u002FLegal Guardian:\n\n• Demonstrated inability to comply with trial protocol requirements","ALL","8 Years","12 Years",{"count":87,"type":88},30,"ESTIMATED","INTERVENTIONAL",[91],"NA","This pilot study aims to evaluate dental caries experience in children ages 8-12 years old through comparing the use of a powered versus manual toothbrush, while using a standardized fluoride toothpaste as the control over the course of one year.",[94,95],"Caries Risk","Caries, Dental",[97,98,99,100],"toothbrush","child","children","cavities","2026-10-05",{"date":103,"type":104},"2026-10-08","ACTUAL",{"date":106,"type":88},"2026-10-28",{"date":108,"type":88},"2028-03-30",{"name":5,"class":6},1]