[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602480":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":26,"responsibleParty":38,"collaborators":26,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":26},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Infiltration","EXPERIMENTAL","Children in this group will receive local anesthesia using the SleeperOne® 5 electronic anesthesia delivery system (Dental Hi-Tec, France). The anesthetic solution used is 3% mepivacaine (Mepecaine-L®, Alexandria Co. for Pharmaceuticals and Chemical Industries, Egypt), administered via the device which controls flow and pressure to minimize discomfort during extraction of maxillary primary molars.",[13],"Device: SleeperOne 5",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Infiltration Technique","ACTIVE_COMPARATOR","Children in this group will receive local anesthesia using conventional infiltration via a standard dental syringe with a 30-gauge short needle. The anesthetic used is 3% mepivacaine (Mepecaine-L®, Alexandria Co. for Pharmaceuticals and Chemical Industries, Egypt). Buccal infiltration will be administered prior to extraction of maxillary primary molars.",[19],"Procedure: (Conventional Infiltration Anesthesia)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","SleeperOne 5","A computerized local anesthetic delivery system (manufactured by Dental Hi-Tec, France) designed to minimize pain perception in children during dental procedures by controlling the pressure and flow rate of anesthetic injection. It will be used to deliver 3% mepivacaine (Mepecaine-L®, Alexandria Co. for Pharmaceuticals, Egypt) during maxillary primary molar extraction in pediatric patients.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","(Conventional Infiltration Anesthesia)","Local anesthetic solution (3% mepivacaine with no vasoconstrictor), manufactured by Alexandria Co. for Pharmaceuticals, Egypt. It will be administered using a 30-gauge short dental needle and standard dental syringe for conventional infiltration anesthesia during primary maxillary molar extraction in pediatric patients.",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Aya Hesham ElTanahy, MSc","CONTACT","201112902348","aya.eltanahy@dentistry.cu.edu.eg",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Aya Hesham ElSayed Mohamed ElTanahy","Master's Candidate in Pediatric Dentistry","100602480","comparison-of-pain-perception-in-a-group-of-pediatric-patients-undergoing-maxillary-primary-molar-extraction-using-a-novel-anesthetic-device-versus-traditional-infiltration-100602480",false,"NCT07124052","Comparison of Pain Perception in A Group of Pediatric Patients Undergoing Maxillary Primary Molar Extraction Using A Novel Anesthetic Device Versus Traditional Infiltration","Comparison of Pain Perception in a Group of Pediatric Patients Undergoing Maxillary Primary Molar Extraction Using a Novel Anesthetic Device Versus Conventional Infiltration: A Randomized Controlled Trial","SO5PED","* Inclusion criteria:\n\n  * Children aged 3-5 years old\n  * Medically fit children classified as ASA physical status I and II\n  * Parents acceptance to participate in the study (informed consent)\n  * Pediatric patients having teeth that have been diagnostically confirmed as requiring extraction.\n\nExclusion criteria:\n\n* Uncooperative children.\n* Patients with an allergy to local anesthesia.\n* Children in need of treatment under general anesthesia.","ALL","3 Years","5 Years",{"count":54,"type":55},2,"ESTIMATED","INTERVENTIONAL",[58],"NA","This study aims to compare the pain felt by children during tooth extraction using two different techniques for giving local anesthesia. One group of children will receive anesthesia using a modern electronic device called SleeperOne® 5, which controls the flow and pressure of the anesthesia to reduce pain. The other group will receive anesthesia using the traditional syringe method, which is more commonly used in dental clinics.\n\nThe study will include children between the ages of 3 and 5 years old who need to have an upper baby molar tooth extracted. All children in the study will be healthy (classified as ASA I or II), and their parents must agree to participate.\n\nDuring the procedure, each child will first receive a topical anesthetic gel to numb the surface. Then, based on random selection, the child will receive local anesthesia using either the SleeperOne® 5 device or the traditional syringe. Pain levels during the injection and during the extraction will be measured using special scales suitable for children. Other factors like how long the anesthesia takes to work and how long it lasts will also be recorded.\n\nThis research will help dentists understand whether the SleeperOne® 5 device offers a more comfortable experience for young children compared to the traditional method. The goal is to reduce fear and pain during dental treatments for kids.",[61,62],"Pain","Extraction, Tooth",[64,65,23,66,9],"Pediatric Dentistry","Pain Perception","Computer-Controlled Anesthesia","NOT_YET_RECRUITING","2025-08-16",{"date":70,"type":71},"2025-08-22","ACTUAL",{"date":73,"type":55},"2025-08-18",{"date":75,"type":55},"2026-09-18",{"name":40,"class":6}]