[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633275":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":42,"responsibleParty":59,"collaborators":31,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":31,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":31,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":45,"whyStopped":31,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Izmir Katip Celebi University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intraligamentary Anaesthesia","EXPERIMENTAL","Before the restorative treatment of mandibular first molar, SOPIRA® 30 gauge extra-short cartridge needle attached to the tip of the SOPIRA® Citoject (SOPIRA® Heraeus Kulzer, Hanau, Almanya) pressure injector will be inserted into the periodontal sulcus 1-2 mm until resistance. The needle will be at an angle of 30 degrees to the long axis of the tooth. As recommended by the manufacturer, a total of 0.36 ml (mesiobuccal and distobuccal) 4% articaine solution containing 1:100,000 epinephrine (Ultracaine DS forte cartridge, Sanofi-Aventis GmbH, Almanya) will be injected slowly over 42 seconds by pressing the dosing lever 3 times for each root. If the anaesthesia will be failed, we would use the 4-point IL injection by injecting the mesiolingual sulcus and distolingual sulcus with the same technique.",[13],"Procedure: Intraligamentary anaesthesia",{"label":15,"type":16,"description":17,"interventionNames":18},"Digital Intraosseous Anesthesia","ACTIVE_COMPARATOR","For the digital intraosseous anesthesia technique, the handpiece will be stabilized by holding it as close to the needle as possible and maintaining firm support on the device holder to ensure maximum precision. To enhance the accuracy of movements, stable intraoral finger rests will be used throughout the procedure. The Effitec needle will be positioned at the papillary apex and oriented toward the area between the apices of the two adjacent teeth.\n\nTo maintain correct needle positioning and prevent rotational movement, the handpiece will be held nearly parallel to the gingival tissues. Penetration will be directed toward the center of the interdental septum. When the needle enters the cancellous bone, a characteristic sensation similar to cracking an eggshell may be perceived. Before initiating the injection, the needle will be slightly withdrawn to ensure proper placement and avoid excessive penetration.",[19],"Procedure: Digital Intraosseous Anesthesia",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Intraligamentary anaesthesia","Anesthesia One tooth anaesthesia by 2 or 4 points intraligamentary injection",[9],[27],"2 or 4 points intraligamentary injection",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Anesthesia for one tooth using computer-controlled single-point injection into cancellous bone",[15],null,[33,38],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Funda Çağırır Dindaroğlu, Study Director","CONTACT","+905363465653","fundacagirir@gmail.com",{"name":39,"role":35,"phone":40,"phoneExt":31,"email":41},"Buse Düzgün, Principal Investigator","+905073022366","busedzgn@hotmail.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":31,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Izmir Katip Çelebi University Faculty of Dentistry","RECRUITING","Izmir","Cigli","35000","Turkey (Türkiye)",{"type":51,"coordinates":52},"Point",[53,54],27.13838,38.41273,{"lat":54,"lon":53},[57],{"name":58,"role":35,"phone":40,"phoneExt":31,"email":41},"Buse Duzgun",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Funda Cagırır Dindaroglu","Assoc. Prof. Dr.","100633275","comparison-of-digital-intraosseous-and-manual-intraligamentary-anesthesia-in-children-100633275",false,"NCT07524569","Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children","Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Subjects with American Society of Anesthesiologists score I (ASA I)\n* Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),\n* Subjects with indication of similar restoration treatment on bilateral first -permanent mandibular molars\n* Subjects whose plaque index score of 0 (no plaque) and 1\n* Subjects whose gingival index score of 0\n\nExclusion Criteria:\n\n* Allergic to the local anesthetics or sulfites\n* Subjects with cholinesterase deficiency\n* Subjects who use drugs that may affect the assessment of pain, such as narcotic or non-narcotic analgesic, anti-inflammatory, anxiolytic, antipsychotic and antihistamine agents\n* Subjects who need to use sedatives or other medications during dental procedures",true,"ALL","6 Years","12 Years",{"count":75,"type":76},78,"ESTIMATED","INTERVENTIONAL",[79],"NA","The aim of this study is to compare the effects of digital intraosseous anesthesia and manual intraligamentary anesthesia techniques on pain scores during the restorative treatment of permanent mandibular molars in pediatric patients. In addition, the techniques will be compared in terms of injection pain, anesthetic success, postoperative complications, and patient preferences. This randomized, controlled, crossover, single-blind, split-mouth study will be conducted on 78 children aged 6-12 years. Participants with bilateral permanent mandibular molars presenting enamel-dentin carious lesions will be included in the study.",[82,83],"Anesthesia","Local",[85,86,15],"intraligamentary anesthesia","paediatric dentistry","2026-04-05",{"date":89,"type":90},"2026-04-13","ACTUAL",{"date":92,"type":76},"2026-04-01",{"date":94,"type":76},"2027-10",{"name":5,"class":6},1]