[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636868":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":68,"collaborators":31,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":31,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":31,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":95,"whyStopped":31,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Inferior alveolar nerve block Injection using Vibraject system(MiltexInc LLC.,York,PA,USA).","EXPERIMENTAL","VibraJect is a compact, battery-operated unit that attaches directly to a standard dental syringe, generating high-frequency vibrations along the needle to attenuate pain during anesthetic delivery. If these devices prove efficacy, they may offer a rapid, non-pharmacologic method to enhance the comfort of children undergoing local anesthesia.",[13],"Device: Vibraject",{"label":15,"type":10,"description":16,"interventionNames":17},"Inferior alveolar nerve block Injection using Dentalvibe system (BING Innovations LLC,Crystal La).","The DentalVibe device is a cordless, rechargeable instrument that produces controlled, pulsed micro-vibrations at the injection site. It features a U-shaped vibrating tip connected to a microprocessor-driven VibraPulse motor, allowing gentle stimulation of sensory receptors, illumination of the injection area, and retraction of the cheek or lip.",[18],"Device: Dental vibe",{"label":20,"type":21,"description":22,"interventionNames":23},"Inferior alveolar nerve block Injection using the Conventional Syringe.","ACTIVE_COMPARATOR","A conventional metal aspirating syringe",[24],"Device: Conventional syringe",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Vibraject","Familiarize the child with the Vibraject device, allowing them to feel the vibrations on their hand to reduce anxiety.\n\nDry the injection site with sterile gauze. Apply 20% benzocaine gel for 1 minute using a cotton swab.\n\nUse a conventional syringe with the Vibraject attachment, 4% articaine (1:100,000 epi), and a 27-gauge long needle.\n\nDeliver an inferior alveolar and lingual nerve block. Slowly deposit 1.5 mL of anesthetic over at least 60 seconds to minimize discomfort.\n\nUse the FLACC scale (objective) during injection and the Wong-Baker FACES scale (subjective) immediately after.\n\nMonitor heart rate and oxygen saturation via pulse oximetry at baseline and during injection.\n\nConfirm anesthesia after 3-5 minutes via numbness (subjective) and lack of pain during instrumentation (objective).\n\nPerform (extraction or pulp therapy or cavity preparation) per AAPD guidelines. Provide post-operative instructions to the parent and evaluate the need for a space maintainer.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Dental vibe","Familiarize the child with the DentalVibe device, letting them feel the vibrations on the back of their hand.\n\nDry the mucosa with gauze and apply 20% benzocaine gel for 1 minute. Apply the DentalVibe to the buccal mucosa for pre-injection vibration. Using a conventional syringe (4% articaine, 1:100,000 epi, 27G needle), perform the mandibular block simultaneously while the DentalVibe is active.\n\nSlowly deposit 1.5 mL (1.0 mL alveolar \u002F 0.5 mL lingual) over at least 60 seconds.\n\nEvaluate pain using the FLACC scale (during) and the Wong-Baker FACES scale (after).\n\nRecord heart rate and oxygen saturation at baseline and during the injection. After 3-5 minutes, confirm anesthesia via subjective numbness and objective lack of pain during instrumentation.\n\nPerform treatment (extraction\u002Fpulp therapy\u002Fcavity prep) per AAPD guidelines. Provide post-operative care instructions and assess the need for space maintainers.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Conventional syringe","Dry the injection site with sterile gauze. Apply 20% benzocaine gel for 1 minute using a cotton swab to ensure surface numbing.\n\nUse a conventional metal aspirating syringe with 4% articaine (1:100,000 epi) and a 27-gauge long needle.\n\nDeliver a mandibular inferior alveolar nerve block. Slowly deposit 1.5 mL total (1.0 mL for the alveolar nerve and 0.5 mL for the lingual nerve) over a minimum of 60 seconds.\n\nEvaluate pain using the FLACC scale (during) and the Wong-Baker FACES scale (after).\n\nRecord heart rate and oxygen saturation at baseline and during the injection. After 3-5 minutes, confirm anesthesia via subjective numbness and objective lack of pain during instrumentation.\n\nPerform (extraction, pulp therapy, or cavity preparation) according to AAPD guidelines.\n\nProvide post-operative care instructions and evaluate the patient for potential space maintainer requirements.",[20],[41],{"name":42,"affiliation":5,"role":43},"Mahmoud H Eid, Professor","STUDY_DIRECTOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Yasmeen MHM Amer, Bachelors","CONTACT","+201124054504","yasmeen.mohamed@dentistry.cu.edu.eg",[51],{"facility":52,"status":31,"city":53,"state":31,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Faculty of Dentistry,Cairo University","Cairo","11411","Egypt","EG",{"type":58,"coordinates":59},"Point",[60,61],31.24967,30.06263,{"lat":61,"lon":60},[64],{"name":65,"role":47,"phone":66,"phoneExt":31,"email":67},"Yasmeen MHM Amer, Bachelors'","00201124054504","yasmeen.mohamed@cu.edu.eg",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Yasmeen Mohamed Hussein Mohamed Amer","Principal Investigator","100636868","pain-perception-during-inferior-alveolar-nerve-block-administration-in-children-using-vibraject-and-dental-vibe-versus-conventional-syringe-100636868",false,"NCT07571278","Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe","Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Children aged 6-8 years.\n* Cooperative children (Rating 3 or 4 based on the Frankl behaviour scale).\n* Medically fit children (ASA I).\n* Children mentally capable of communication.\n* First dental visit (no previous history of injection of LA).\n* Patient requiring extraction\u002Fpulp therapy\u002Fcavity preparation in mandibular primary molars\n\nExclusion Criteria:\n\n* Uncooperative patient (other than 3 or 4 based on the Frankl behaviour scale).\n* Medically unfit children (other than ASA 1).\n* Parental refusal of participation.\n* Children under medications (antibiotics and analgesics) for the previous 48 hours that could alter the pain perception.\n* Children who are allergic to local anaesthesia.",true,"ALL","6 Years","8 Years",{"count":84,"type":85},90,"ESTIMATED","INTERVENTIONAL",[88],"NA","This RCT study aims to establish evidence based decision comparing between Vibraject (MiltexInc LLC.,York,PA,USA).and Dental vibe(BING Innovations LLC,Crystal Lake,IL,USA versus Conventional Syringe on pain perception during inferior alveolar nerve block anesthesia in lower primary molars indicated for extraction,pulp therapy and cavity preparation in Children.",[91],"Anesthesia Effectiveness",[28,33,93,94],"Pain perception","Inferior alveolar nerve block","NOT_YET_RECRUITING","2026-05-05",{"date":98,"type":99},"2026-05-08","ACTUAL",{"date":101,"type":85},"2026-05",{"date":103,"type":85},"2027-08",{"name":5,"class":6},1]