[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649286":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":40,"responsibleParty":56,"collaborators":33,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":33,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":33,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":33,"overallStatus":79,"whyStopped":33,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Marmara University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Computer-Controlled Local Anesthesia","EXPERIMENTAL","Local anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol. The device electronically controls the injection flow rate and pressure. A 4% articaine solution with 1:100,000 epinephrine will be used before restorative treatment of the MIH-affected permanent molar.",[13],"Device: Computer-Controlled Local Anesthesia",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Local Anesthesia","ACTIVE_COMPARATOR","Local anesthesia will be administered using a conventional dental syringe. Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.",[19],"Procedure: Conventional Local Anesthesia",[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Local anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol. The device electronically controls the flow rate and pressure of the anesthetic solution. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.",[9],[26,27],"SleeperOne","Digital Anesthesia",{"type":29,"name":15,"description":17,"armGroupLabels":30,"otherNames":31},"PROCEDURE",[15],[32],"Traditional Local Anesthesia",null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Betül Şen Yavuz, DDS","CONTACT","+905399887646","dtbetulsen@gmail.com",[41],{"facility":42,"status":33,"city":43,"state":44,"zip":45,"country":46,"countryCode":33,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi","Istanbul","Maltepe","34854","Turkey (Türkiye)",{"type":48,"coordinates":49},"Point",[50,51],28.94966,41.01384,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":38,"phoneExt":33,"email":39},"Betul Sen Yavuz",{"type":57,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100649286","comparison-of-computer-assisted-and-conventional-local-anesthesia-in-children-with-molar-incisor-hypomineralization-100649286",false,"NCT07733011","Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization","Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization: A Split-Mouth Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Children aged 8-12 years\n* Children with no systemic disease\n* Children with no pathology involving the oral region, such as trauma, cysts, or tumors\n* Children who have not used antibiotics within the past month\n* Children who have not used nonsteroidal anti-inflammatory drugs (NSAIDs) within the past month\n* Children with at least two homologous permanent molars affected by molar-incisor hypomineralization (MIH) and indicated for restorative treatment due to dentin caries\n* Children with a Frankl Behavior Rating Scale score of 3 or higher will be included in the study\n\nExclusion Criteria:\n\n* Children in whom local anesthesia cannot be administered due to lack of cooperation\n* Children who require pulp treatment after enrollment in the study will be withdrawn from the study.",true,"ALL","8 Years","12 Years",{"count":70,"type":71},54,"ESTIMATED","INTERVENTIONAL",[74],"NA","The main questions this study aims to answer are:\n\nDoes computer-controlled local anesthesia cause less pain and anxiety than conventional local anesthesia in children with molar-incisor hypomineralization (MIH)?\n\nIs there a difference between the two methods in anesthesia onset time, injection duration, physiological responses, and the need for additional anesthesia?\n\nResearchers will compare computer-controlled and conventional local anesthesia in children aged 8-12 years with MIH. Each child will receive both anesthesia methods during separate dental visits, on comparable permanent molar teeth, to determine which method is more comfortable, effective, and preferred by children.",[77,78,9],"Molar-Incisor Hypomineralization","Molar-Incisor Hypomineralization (MIH)","NOT_YET_RECRUITING","2026-07-28",{"date":82,"type":83},"2026-07-29","ACTUAL",{"date":85,"type":71},"2026-08-11",{"date":87,"type":71},"2027-11-01",{"name":5,"class":6},1]