[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504717":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":47,"locations":54,"responsibleParty":70,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":36,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":57,"whyStopped":36,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Claude Bernard University","OTHER",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Group using sonic toothbrush","EXPERIMENTAL","Patients will be asked to use a sonic toothbrush for 24 months",[13],"Device: Sonicare Diamond Clean 9000",{"label":15,"type":10,"description":16,"interventionNames":17},"Group using hydrosonic toothbrush","Patients will be asked to use a hydrosonic toothbrush for 24 months",[18],"Device: HydroSonic Pro",{"label":20,"type":21,"description":22,"interventionNames":23},"Group using manual toothbrush","PLACEBO_COMPARATOR","Patients will be asked to use a manual toothbrush for 24 months",[24],"Device: Oral-B 123",{"label":26,"type":10,"description":27,"interventionNames":28},"Group using manual toothbrush with 5460 strands","Patients will be asked to use a manual toothbrush with 5460 strands for 24 months",[29],"Device: Curaprox CS 5460",[31,37,41,44],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","Sonicare Diamond Clean 9000","Brush teeth with the electric toothbrush 1 daily during the orthodontic treatment",[9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"HydroSonic Pro","Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment",[15],{"type":32,"name":42,"description":39,"armGroupLabels":43,"otherNames":36},"Oral-B 123",[20],{"type":32,"name":45,"description":39,"armGroupLabels":46,"otherNames":36},"Curaprox CS 5460",[26],[48],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Florence Carrouel, PhD","CONTACT","0478785745","+33","florence.carrouel@univ-lyon1.fr",[55],{"facility":56,"status":57,"city":58,"state":36,"zip":36,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Centre de soin dentaire","RECRUITING","Nancy","France","FR",{"type":62,"coordinates":63},"Point",[64,65],6.18496,48.68439,{"lat":65,"lon":64},[68],{"name":69,"role":50,"phone":36,"phoneExt":36,"email":36},"Céline Clément",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Carrouel Florence","Associate professor",[75],{"name":76,"class":6},"University of Nancy","100504717","toothbrushes-in-daily-practice-in-patients-with-fixed-orthodontic-appliances-100504717",false,"NCT05851963","Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances","Comparison of the Effectiveness of Manual and Electric Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances","ORTHO-IOP","Inclusion Criteria:\n\n* Children to be treated with fixed upper and lower braces\n* 11 to 15 years of age at the start of treatment\n* One parent\u002Flegal guardian agrees to the terms and conditions of the study and signs the informed consent form\n* The adolescent agrees to the terms and conditions of the study and signs the informed consent form\n\nExclusion Criteria:\n\n* Less than 20 permanent teeth with braces or brackets\n* Presence of untreated cavities\n* Bleeding greater than 10% on probing\n* Presence of a gingival pocket larger than 5 mm\n* Presence of fixed prosthetic restorations\n* Presence of any enamel development defect\n* Presence of dental anomalies or direct\u002Findirect labial restorations on teeth\n* Patients requiring orthognathic surgeries\n* Presence of systemic diseases (diabetes, hepatic, renal, hematologic, cardiovascular)\n* Use of medications that may affect gingival health (such as calcium channel blockers, ciclosporin and anticoagulants)\n* Use of antibiotics and anti-inflammatory drugs for any purpose over a long period of time.\n* Having a smoking habit\n* Having a physical or mental problem that affects manual dexterity\n* Being unable to answer questions or being uncooperative",true,"ALL","11 Years","15 Years",{"count":90,"type":91},120,"ESTIMATED","INTERVENTIONAL",[94],"NA","Because of the difficulties of disorganizing the dental biofilm in these adolescents with fixed orthodontic treatment, electric toothbrushes have been proposed as an alternative to manual toothbrushes. Electric toothbrushes, available in a wide range of price points, have been developed with the goal of replicating the complex motions required by the manual toothbrush and making plaque removal more efficient. However, the overall effect size is limited, and the clinical relevance is not yet clear. Applied to orthodontics, specialized manual toothbrushes have also recently been developed. Few recent clinical trials have been conducted in patients with orthodontic appliances.\n\nThus, the question of whether and which type of manual or electric toothbrushes may be beneficial for patients with orthodontic appliances is still unresolved. Given the variety of toothbrushes available on the market, there is a need for sound clinical research to evaluate their effectiveness to guide professional recommendations. This work will provide a significant advance in the knowledge of the potential of the latest generation of electric toothbrushes on gingival inflammation, potentially reducing the risk of caries and gingival lesions.",[97],"Dental Malposition",[99,100,101,102],"toothbrush","oral prophylaxis","adolescents","orthodontic appliances","2026-03-16",{"date":105,"type":106},"2026-03-18","ACTUAL",{"date":108,"type":106},"2025-04-01",{"date":110,"type":91},"2027-12-20",{"name":5,"class":6},1]