[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596412":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":40,"locations":47,"responsibleParty":59,"collaborators":45,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":45,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":45,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":49,"whyStopped":45,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Maxillary right primary molar","ACTIVE_COMPARATOR","Maxillary right primary molar will receive electronic anesthesia",[13],"Device: Electronic anesthesia",{"label":15,"type":10,"description":16,"interventionNames":17},"Maxillary left primary molar","Maxillary left primary molar will receive conventional anesthesia",[18],"Device: Conventional anesthesia",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Electronic anesthesia","The child will receive electronic anesthesia to the right side of the upper jaw; the pain and anxiety level will be assessed.",[9],[26],"pen injector",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Conventional anesthesia","The child will receive conventional anesthesia to the maxillary left side",[15],[32],"Conventional syringe",[34,38],{"name":35,"affiliation":36,"role":37},"Reham Khaled Elghazawy, Associate professor","Faculty of Dentistry, Ain Shams university","STUDY_DIRECTOR",{"name":39,"affiliation":36,"role":37},"Nour Wahba, Lecturer\u002F Pedodontist",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Randa Omer, Master's degree candidate","CONTACT","+201156298126",null,"randaomar@dent.asu.edu.eg",[48],{"facility":36,"status":49,"city":50,"state":45,"zip":45,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":45},"RECRUITING","Cairo","Egypt","EG",{"type":54,"coordinates":55},"Point",[56,57],31.24967,30.06263,{"lat":57,"lon":56},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"SPONSOR_INVESTIGATOR","Randa Omer Ahmed Bashir","Master's degree candidate at Pediatric department, Ain Shams University","100596412","electronic-vs-conventional-syringes-impact-on-pediatric-pain-and-anxiety-100596412",false,"NCT07045116","Electronic vs. Conventional Syringes: Impact on Pediatric Pain and Anxiety","Effectiveness of Electronic Anesthesia Delivery Syringe Versus Conventional Syringe on Pain and Anxiety Perception During Local Anesthetic Injection in Children Randomized Clinical Trial","Inclusion Criteria:\n\n* 6-8-year-old children.\n* Medically free (ASA class I).\n* Children attending their first dental visit.\n* The patient should have at least one vital primary molar with deep carious lesion on each side.\n\nExclusion Criteria:\n\n* Patient has any allergy to local anesthesia.\n* Patients take any medications that affect the salivary flow.\n* Patient taken corticosteroid.\n* Children whose parents or legal guardians refuse to sign the informed consent.",true,"ALL","6 Years","8 Years",{"count":75,"type":76},40,"ESTIMATED","INTERVENTIONAL",[79],"NA","Study Overview Purpose: To compare pain and anxiety levels in children aged 6-8 during local anesthesia administration using electronic vs. conventional syringes.\n\nDesign: Split-mouth randomized controlled trial (RCT) involving 40 children receiving both types of anesthesia during pulp therapy of bilateral maxillary primary molars.\n\nObjectives Primary Outcome: Pain level measured via Visual Analogue Scale (VAS).\n\nSecondary Outcomes:\n\nPhysiological markers: heart rate and oxygen saturation via pulse oximetry.\n\nSalivary amylase levels (anxiety biomarker) assessed using ELISA.\n\nMethodology Children are randomly assigned to receive electronic anesthesia on one side and conventional on the other in two separate visits.\n\nSaliva samples are collected before and after each injection.\n\nDouble-blind setup: children blinded using sunglasses; statistician also blinded.\n\nSame operator administers all injections for consistency.\n\nEthical Considerations Written informed consent and assent obtained.\n\nRisks (e.g., systemic toxicity, allergic reactions) minimized via dosage limits and patient monitoring.\n\nPrivacy and data security measures in place.\n\nStatistical Analysis Data analyzed using SPSS; significance set at p ≤ 0.05.\n\nSample size calculated for adequate power (n = 33 minimum; 40 enrolled).\n\nFunding Self-funded.\n\nClinical Relevance Electronic anesthesia may offer a less painful and anxiety-inducing alternative for pediatric dental patients, potentially improving children's long-term attitude toward dental care.",[82,83],"Dental Anxiety","Pain Management",[85,86,87,88],"dental anxiety","salivary amylase","dental syringes","electronic anesthesia","2025-07-29",{"date":91,"type":92},"2025-07-31","ACTUAL",{"date":94,"type":92},"2024-12-01",{"date":96,"type":76},"2025-08-30",{"name":61,"class":6},1]