[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530481":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":34,"responsibleParty":90,"collaborators":18,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":18,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":18,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":18,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Region Örebro County","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early maxillary expansion","EXPERIMENTAL","The subjects in the experimental group will be treated with a maxillary expansion appliance with bands on the second deciduous molars and arms to the deciduous canines. The screw gives a expansion of 0,20 millimeter per activation. The arms are bonded to the deciduous canines with light curing composite and the bands are cemented with glassionomer cement.\n\nThe subject are instructed to activate the appliance once a day (1\u002F4 turn) for 2 weeks and thereafter every second day until adequate space for the lateral incisors is obtained.During the expansion the subjects will be asked to complete a questionnaire on pain and discomfort.\n\nThe subjects will be recalled for follow-up visits after 24 months (T1), 36 months (T2), 48 months (T3) and when all permanent premolars are erupted (T4).\n\nAt T1, T2 and T4 the subjects are asked to fill out the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ).\n\nThe subjects need for further treatment will be evaluated and initiated at T4.",[13],"Device: Maxillary expansion device",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","The control group is not going to receive any treatment under the observation period.\n\nThe subjects will be recalled for follow-up visits with photographs (4 extraoral photos and 5 intraoral photos) and study models (digital or cast) after 24 months (T1), 36 months (T2), 48 months (T3) and when all permanent premolars are erupted (T4).\n\nAt T1, T2 and T4 the subjects are asked to fill out the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) to evaluate their oral health related quality of life.\n\nThe subjects need for further treatment will be evaluated and initiated at T4.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Maxillary expansion device","The maxillary expansion device is a orthodontic appliance that is used to expand the maxilla in children.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Emil Östlund, DDS","CONTACT","+46196024045","emil.ostlund@regionorebrolan.se",{"name":32,"role":28,"phone":29,"phoneExt":18,"email":33},"Farhan Bazargani, DDS","farhan.bazargani@regionorebrolan.se",[35,51,65,79],{"facility":36,"status":37,"city":38,"state":18,"zip":18,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Postgraduate School of Orthodontics, University of L'Aquila","RECRUITING","Coppito","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],13.34358,42.3673,{"lat":45,"lon":44},[48],{"name":49,"role":28,"phone":18,"phoneExt":18,"email":50},"Simone Ettore Salvati, DDS","simoneettore.salvati@graduate.univaq.it",{"facility":52,"status":37,"city":53,"state":18,"zip":54,"country":39,"countryCode":40,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Universita Degli Studi Di Milano","Milan","20122",{"type":42,"coordinates":56},[57,58],12.59836,42.78235,{"lat":58,"lon":57},[61],{"name":62,"role":28,"phone":63,"phoneExt":18,"email":64},"Alberto Caprioglio, Professor","+39-02 50320240","alberto.caprioglio@unimi.it",{"facility":66,"status":37,"city":67,"state":18,"zip":18,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"The Institute for Postgraduate Dental Education in Jönköping","Jönköping","Sweden","SE",{"type":42,"coordinates":71},[72,73],14.15618,57.78145,{"lat":73,"lon":72},[76],{"name":77,"role":28,"phone":18,"phoneExt":18,"email":78},"Cecilia Hedmo, DDS","cecilia.hedmo@rjl.se",{"facility":80,"status":37,"city":81,"state":18,"zip":82,"country":68,"countryCode":69,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Emil Östlund","Örebro","70383",{"type":42,"coordinates":84},[85,86],15.2066,59.27412,{"lat":86,"lon":85},[89],{"name":80,"role":28,"phone":29,"phoneExt":18,"email":30},{"type":91,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100530481","interceptive-maxillary-expansion-to-relief-anterior-crowding-in-the-mixed-dentition-100530481",false,"NCT06187337","Interceptive Maxillary Expansion to Relief Anterior Crowding in the Mixed Dentition","Interceptive Maxillary Expansion to Relief Anterior Crowding in the Mixed Dentition: a Longitudinal, Randomized Controlled Trial","Inclusion Criteria:\n\n* Healthy subjects without sucking habits\n* Permanent maxillary central incisors and first permanent molars fully erupted. DS1M1.\n* No severe crowding or protrusion in the lower arch considering the Leeway space and normal development of the arch.\n* Permanent first molar in normal transversal relation.\n* Crowding of the maxillary incisors with the lateral incisor just erupting ectopically or not yet emerged through the gingiva.\n* Crowding greater than or equal to 6 millimeters between the upper deciduous canines.\n\nExclusion Criteria:\n\n* Skeletal asymmetries, anomalies and syndromes.\n* Previous orthodontic treatment","ALL","6 Years","16 Years",{"count":103,"type":104},60,"ESTIMATED","INTERVENTIONAL",[107],"NA","The goal of this clinical trial is to compare if it is better to treat severe anterior crowding in the early mixed dentition then later in the permanent dentition in children with anterior crowding of the upper teeth. The main questions this trial aims to answer are:\n\n* If there is a difference in the degree of anterior crowding between the experimental group and the control group after a five year follow-up period.\n* If there is a difference between the experimental group and the control group in regard to oral health related quality of life.\n* If there is spontaneous transversal adaption of the lower dental arch to upper dental arch after maxillary expansion and compare this to the control group.\n* If early maxillary expansion is more cost-effective than treatment in the permanent dentition.\n\nTo be eligible for this trial the subject must be children between six and nine years old at the time for inclusion. The children must have crowding of the upper front teeth of six millimeters or more and the lateral incisors should not have erupted or just erupted through the gingiva.\n\nSubjects randomized to the experimental group will get an expansion treatment in the upper jaw with rapid maxillary expansion device to gain enough space for the lateral incisors to erupt. All subjects, also the subjects randomized to the control group, are followed until all permanent teeth have erupted.\n\nAt the end of the follow-up period all subjects fill out a questionnaire to evaluate their oral health related quality of life.\n\nResearchers will then compare the subjects in both groups to evaluate if there is a difference in anterior crowding after the follow-up period. Differences in cost-effectiveness, morphological changes and the subjects oral health related quality of life will also be evaluated.",[110,111,112],"Crowding of Anterior Maxillary Teeth","Orthodontics, Interceptive","Orthodontics, Corrective, Palatal Expansion Technique","2025-07-15",{"date":115,"type":116},"2025-07-18","ACTUAL",{"date":118,"type":116},"2021-12-20",{"date":120,"type":104},"2028-01-31",{"name":5,"class":6},4]