[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597254":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":46,"centralContacts":50,"locations":56,"responsibleParty":63,"collaborators":36,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":36,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":98,"whyStopped":36,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"GENI High-Speed Injection","EXPERIMENTAL","Participants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to high-speed injection mode. Buccal and intrapapillary infiltration will be administered using 4% articaine with 1:100,000 epinephrine. The injection will be performed by the principal investigator following a standardized technique. Pain perception will be evaluated immediately after injection.",[13],"Device: GENI High-Speed Injection",{"label":15,"type":10,"description":16,"interventionNames":17},"GENI Moderate-Speed Injection","Participants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to moderate-speed injection mode. The injection will include buccal and intrapapillary infiltration using 4% articaine with 1:100,000 epinephrine. The procedure will be performed by the principal investigator using a standardized technique. Pain perception will be assessed immediately following the injection.",[18],"Device: GENI Moderate-Speed Injection",{"label":20,"type":10,"description":21,"interventionNames":22},"GENI Low-Speed Injection","Participants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to low-speed injection mode. Buccal and intrapapillary infiltration will be administered using 4% articaine with 1:100,000 epinephrine. The injection will be performed by the principal investigator following a standardized protocol. Pain perception will be evaluated using subjective, objective, and physiological measures.",[23],"Device: GENI Low-Speed Injection",{"label":25,"type":26,"description":27,"interventionNames":28},"A Conventional dental Syringe","ACTIVE_COMPARATOR","Participants in this arm will receive local anesthesia using a traditional metal aspirating dental syringe (C-K JECT) with a short 30-gauge needle. Buccal and intrapapillary infiltration will be performed using 4% articaine with 1:100,000 epinephrine, following a standardized injection technique. The procedure will be conducted by the principal investigator. Pain perception will be assessed immediately after the injection using subjective, objective, and physiological parameters.",[29],"Device: A conventional dental syringe",[31,37,40,43],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","A conventional dental syringe","The conventional dental syringe (C-K JECT) is a manual, metal aspirating syringe commonly used for local anesthesia administration in dental procedures. In this study, the device is used to perform buccal and intrapapillary infiltration using 4% articaine with 1:100,000 epinephrine. Injections are delivered manually at a standardized rate by the principal investigator. This arm serves as the active comparator to evaluate differences in pain perception between traditional syringe injections and those delivered via a computer-controlled device.",[25],null,{"type":32,"name":9,"description":38,"armGroupLabels":39,"otherNames":36},"The GENI device is a computer-controlled local anesthesia delivery system that automates the injection process using pressure feedback to regulate flow. In this arm, the device is set to high-speed mode to deliver the anesthetic solution at the fastest available flow rate. Buccal and intrapapillary infiltration is performed using 4% articaine with 1:100,000 epinephrine. The procedure is carried out by the principal investigator using a standardized technique. Pain perception is assessed following injection to evaluate the impact of delivery speed on patient experience.",[9],{"type":32,"name":15,"description":41,"armGroupLabels":42,"otherNames":36},"The GENI device is a computer-controlled local anesthesia delivery system designed to regulate flow and pressure during injection using real-time feedback. In this arm, the device is set to moderate-speed mode, delivering anesthetic at an intermediate flow rate. Buccal and intrapapillary infiltration is performed using 4% articaine with 1:100,000 epinephrine. The injection is administered by the principal investigator using a standardized technique. This group is used to assess the impact of moderate-speed delivery on pain perception and physiological response in pediatric patients.",[15],{"type":32,"name":20,"description":44,"armGroupLabels":45,"otherNames":36},"The GENI device is a computer-controlled local anesthesia delivery system that maintains precise control over injection pressure and flow. In this arm, the device is set to low-speed mode, delivering the anesthetic solution at the slowest available rate to minimize tissue pressure and potential discomfort. Buccal and intrapapillary infiltration is administered using 4% articaine with 1:100,000 epinephrine. The injection is performed by the principal investigator using a standardized technique. This group evaluates whether low-speed delivery reduces pain perception and improves patient comfort compared to faster injection speeds and conventional methods.",[20],[47],{"name":48,"affiliation":5,"role":49},"Dr. Mariam mohsen Associate Professor of Pediatric Dentistry and Dental Public","STUDY_CHAIR",[51],{"name":52,"role":53,"phone":54,"phoneExt":36,"email":55},"tarek MHD kher alsaka amini, Master degree","CONTACT","+201127255997","alsakatarek42@gmail.com",[57],{"facility":5,"status":36,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":36,"geoPoint":36,"contacts":36},"Cairo","Giza Governorate","3755220","Egypt","EG",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"SPONSOR_INVESTIGATOR","Tarek MHD kher al saka amini","DOCTOR","100597254","study-of-pain-perception-using-computer-controlled-versus-conventional-local-anaesthesia-in-children-undergoing-molar-extraction-100597254",false,"NCT07056101","\"Study of Pain Perception Using Computer-Controlled Versus Conventional Local Anaesthesia in Children Undergoing Molar Extraction","Evaluation of Pain Perception Using Computer-Controlled Local Anaesthesia Delivery With Different Injection Speeds Versus Conventional Anaesthesia for Maxillary Primary Molars: A Randomized Controlled Trial","CCLAD-Pain","Inclusion Criteria:\n\n* Children aged from 6 to 8 years old\n* Both sexes\n* Healthy children classified as ASA I\n* Children with maxillary primary molars indicated for extraction\n* No previous dental experience\n* Mentally capable of communication and following instructions\n* No acute dental pain\n\nExclusion Criteria:\n\n* Uncooperative children or those with a behavioral management problem (Frankl rating 1 or 2)\n* Children with known allergies to the local anesthetic or dental materials used in the study\n* Children taking medications (e.g., antibiotics, analgesics) in the previous 48 hours that may alter pain perception\n* Children whose parents or legal guardians refuse to sign the informed consent form\n* Children experiencing acute dental pain",true,"ALL","6 Years","8 Years",{"count":80,"type":81},76,"ESTIMATED","INTERVENTIONAL",[84],"NA","This clinical trial aims to compare pain perception in children during dental procedures when using a computer-controlled local anesthesia device versus a traditional syringe. Children aged 6 to 8 years who need maxillary primary molar extraction will be randomly assigned to one of four groups: three groups using different speeds of the GENI computer-controlled device, and one group using a conventional syringe. The study will assess pain using facial expression scales and physiological measures such as heart rate. The goal is to find a more comfortable method for delivering anesthesia to pediatric dental patients.",[87,88,89,90],"Dental Phobia","Dental Anxiety","Dental Anesthesia","Dental Anesthesia Efficacy",[92,93,94,95,96,97],"GENI Device","Pain Perception","Local Anesthesia Technique","Articaine","Computer-Controlled Local Anesthesia","Dental Injections","NOT_YET_RECRUITING","2025-07-10",{"date":101,"type":102},"2025-07-14","ACTUAL",{"date":104,"type":81},"2025-07-01",{"date":106,"type":81},"2025-10-31",{"name":65,"class":6},1]