[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100410695":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":11,"centralContacts":45,"locations":51,"responsibleParty":66,"collaborators":11,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":11,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":11,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University Hospital, Strasbourg, France","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Manual toothbrush","ACTIVE_COMPARATOR",null,[13],"Device: Manual toothbrush",{"label":15,"type":16,"description":11,"interventionNames":17},"Arm 2: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)","EXPERIMENTAL",[18],"Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss)",{"label":20,"type":16,"description":11,"interventionNames":21},"Arm 3: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)",[22],"Device: Sonic toothbrush",{"label":24,"type":16,"description":11,"interventionNames":25},"Arm 4: Sonic toothbrush (Philips Sonicare ProtectiveClean) and water flosser",[26],"Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)",[28,33,37,41],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"DEVICE","Manual toothbrush","Patients in group 1 (''reference procedure'') receive a manual toothbrush with a small compact head to facilitate access to the posterior teeth and soft bristles.",[9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Manual toothbrush and water flosser (Philips Sonicare AirFloss)","\\- Group 2 patients receive a manual toothbrush with a small, compact head for easy access to the posterior teeth and soft bristles. They also receive a Philips brand interdental microjet (Philips Sonicare AirFloss Ultra) which must be filled with water.",[15],{"type":29,"name":38,"description":39,"armGroupLabels":40,"otherNames":11},"Sonic toothbrush","\\- Group 3 patients receive a rechargeable sonic electric toothbrush from Philipps with an integrated excess pressure sensor and a compact toothbrush head for easy access to the posterior teeth.",[20],{"type":29,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)","\\- Group 4 patients receive a Philips Sonicare ProtectiveClean rechargeable sonic electric toothbrush with an integrated excess pressure sensor and 2 compact toothbrush heads for easy access to the posterior teeth. They also receive an interdental microjet from Philips (Philips Sonicare AirFloss Ultra) which must be filled with water.",[24],[46],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},"Sophie JUNG","CONTACT","00333.88.11.69.56","sophie.jung1@chru-strasbourg.fr",[52],{"facility":53,"status":54,"city":55,"state":11,"zip":11,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Service de parodontologie","RECRUITING","Strasbourg","France","FR",{"type":59,"coordinates":60},"Point",[61,62],7.74553,48.58392,{"lat":62,"lon":61},[65],{"name":47,"role":48,"phone":11,"phoneExt":11,"email":11},{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100410695","effect-of-the-use-of-specific-oral-hygiene-devices-on-gingival-health-among-patients-with-systemic-sclerosis-100410695",false,"NCT04627857","Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis","ScleroBross","Inclusion Criteria:\n\n* Adult male or female ≥ 18 years (18th birthday completed)\n* Affiliation to a social welfare system\n* Signed informed consent form\n* More than 12 natural teeth suitable for evaluation\n* Systemic sclerosis with cutaneous involvement with a diagnosis based on American College of Rheumatology (ACR) and LeRoy and Metzger criteria\n\nExclusion Criteria:\n\n* Localized scleroderma or systemic sclerosis without cutaneous involvement (\"sine scleroderma\" limited form)\n* Less than 12 natural teeth suitable for evaluation and\u002For mandibular\u002Fmaxillary complete denture(s)\n* Other progressive chronic illness \u002Fautoimmune disease other than systemic sclerosis (e.g. diabetes)\n* Another cause of mucocutaneous sclerosis (e.g. radiotherapy involving the oro-facial region)\n* Current use of sonic toothbrush and\u002For dental water flosser\n* Severe manual handicap preventing the patient from holding a toothbrush with a large handle\n* Oral antiseptics (e.g. chlorhexidin mouthwashes)\n* Ongoing medical treatment inducing a significant modification of the gingival state (e.g. anti-epileptic drugs)\n* Smoking (≥ 10 cigarettes per day)\n* Impossibility to provide accurate information (e.g. emergency situation, comprehension difficulties)\n* Individual under guardianship, curatorship or judicial protection","ALL","18 Years",{"count":78,"type":79},100,"ESTIMATED","INTERVENTIONAL",[82],"NA","Systemic sclerosis is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. This condition has multiple effects on the orofacial region that is involved in approximately 80% of the patients with a significant impact on the quality of life.\n\nThe aim of this randomized single-blind study is to evaluate the impact of the use of a specific oral hygiene instrumentation (sonic toothbrush and water flosser with a large handle) compared to \"standard\" toothbrushing with a manual toothbrush on the gingival health among patients with systemic sclerosis.",[85],"Scleroderma Systemic","2024-08-16",{"date":88,"type":89},"2024-08-19","ACTUAL",{"date":91,"type":89},"2021-07-01",{"date":93,"type":79},"2025-03-01",{"name":5,"class":6},1]