[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604967":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":26,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":78,"locationsCount":26},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Infiltration","ACTIVE_COMPARATOR","Children will receive 3% mepivacaine with conventional syringe after 20% benzocaine",[13],"Procedure: Conventional Infiltration",{"label":15,"type":16,"description":17,"interventionNames":18},"SleeperOne® Device","EXPERIMENTAL","Children will receive 3% mepivacaine using SleeperOne® device after 20% benzocaine.",[19],"Device: SleeperOne®, dental Hitec, France",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","SleeperOne®, dental Hitec, France","SleeperOne® is a computerized local anesthetic delivery system used to deliver 3% mepivacaine following application of 20% benzocaine topical gel. It is designed to reduce injection pain and improve comfort during pediatric dental procedures.",[15],null,{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":26},"PROCEDURE","Local anesthetic (3% mepivacaine) will be administered using a conventional dental syringe after the application of 20% benzocaine topical anesthetic.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ameera Alaa ElDin, MSc Candidate in Pediatric Den","CONTACT","01156165654","ameera.khalifa@dentistry.cu.edu.eg",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Ameera Alaa Eldin Abdalazim Khalifa","MSc Candidate in Pediatric Dentistry, Faculty of Dentistry, Cairo University","100604967","sleeperone-vs-conventional-infiltration-pain-perception-in-mandibular-primary-molar-extraction-100604967",false,"NCT07156396","SleeperOne vs. Conventional Infiltration: Pain Perception in Mandibular Primary Molar Extraction","Comparative Evaluation of A Novel Anesthetic Device vs. Conventional Infiltration in Pain Perception Among A Group of Pediatric Patients Undergoing Extraction Of Mandibular Primary Molars: A Randomized Clinical Trial","SOTIMAN","Inclusion criteria:\n\n* Children Aged between 3 to 5 years.\n* Medically fit children classified as ASA physical status I and II\n* Parents acceptance to participate in the study (informed consent)\n* Children with teeth diagnostically confirmed to require extraction\n\nExclusion criteria:\n\n* Patients with an allergy to local anesthesia.\n* Uncooperative children\n* Children requiring general anesthesia","ALL","3 Years","5 Years",{"count":53,"type":54},28,"ESTIMATED","INTERVENTIONAL",[57],"NA","This clinical trial is being conducted in the Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University. The purpose of the study is to compare the pain perception and comfort of children during tooth extraction when using a computer-controlled local anesthetic device (SleeperOne® 5) versus the conventional syringe infiltration technique.\n\nChildren between 3 and 5 years of age who require extraction of a maxillary primary molar will be invited to participate. Before starting, a topical anesthetic gel (benzocaine) will be applied. Then, local anesthesia will be given using either the SleeperOne® device or the traditional syringe, depending on the group assigned.\n\nPain during injection and extraction will be assessed using both child-friendly rating scales and independent evaluation by the dentist. Patient anxiety, heart rate, and blood pressure will also be recorded.\n\nThis study aims to provide evidence on whether computer-controlled anesthesia can reduce children's pain and anxiety compared with the conventional method, leading to a more comfortable dental experience.\n\nThe study is a randomized clinical trial and will be conducted in a single visit at the Pediatric Dentistry Outpatient Clinic, Faculty of Dentistry, Cairo University. The results may help improve pain management and patient comfort during dental treatment for children.",[60,61,62,63],"Dental Anxiety","Pain","Pain Management","Extraction, Tooth",[65,66,67,68,69,70],"Pediatric dentistry","Tooth extraction","conventional infiltration","sleeperOne 5","Computer-Controlled anesthesia","Pain Perception","NOT_YET_RECRUITING","2025-09-02",{"date":74,"type":75},"2025-09-05","ACTUAL",{"date":72,"type":54},{"date":72,"type":54},{"name":39,"class":6}]