[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604974":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":46,"locations":57,"responsibleParty":69,"collaborators":51,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":51,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":51,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":100,"whyStopped":51,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Dicle University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Digital Dental Anesthesia (CCLAD - Computer Controlled Local Anesthetic Delivery)","EXPERIMENTAL","For Maxillary Teeth: For maxillary teeth, the SleeperOne® 5 electronic local anesthesia system was used. After confirming pulp vitality through a cold or electric pulp test, the target area was dried, and 10% lidocaine topical anesthetic was applied for 1 minute using a cotton pellet. Then, 1.7 ml of Ultracaine D-S Fort was delivered via intraosseous injection using a 30-gauge, 9 mm Effitec needle in pediatric mode.\n\nFor Mandibular Teeth: For mandibular teeth, the SleeperOne® 5 electronic local anesthesia system was used to perform intraosseous injection in pediatric mode. Prior to the injection, pulp vitality was assessed using a cold or electric pulp test. The injection site was then dried, and 10% lidocaine topical anesthetic spray was applied with a cotton pellet for 1 minute. Following this, 1.7 ml of Ultracaine D-S Fort was administered using a 30-gauge, 9 mm Effitec needle.",[13],"Device: Digital Anesthesia with SleeperOne 5",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional Local anesthesia Techniques","ACTIVE_COMPARATOR","For the contralateral maxillary teeth:\n\nAfter confirming vitality, the site is dried and 10% lidocaine spray is applied for 1 minute. Buccal infiltration is performed. The cheek and lip are retracted, mucosa tightened, and the needle inserted at the tooth apex. After bone contact, the needle is withdrawn 1 mm, aspirated, and Ultracaine D-S Fort injected slowly over 1 minute using a 30G, 16 mm Effitec needle and metal carpule syringe.\n\nFor the contralateral mandibular teeth:\n\nThe retromolar area is dried, and 10% lidocaine spray is applied with a cotton pellet for 1 minute. After retracting the cheek and lip, the needle is inserted between the pterygomandibular raphe and internal oblique ridge, aligned with the contralateral molars. After bone contact, aspiration is performed. Ultracaine D-S Fort is slowly injected over 1 minute using a traditional metal carpule syringe and a 27-gauge, 35 mm Effitec needle following the standard inferior alveolar nerve block technique.",[19,20],"Device: Infiltration Anesthesia with a Metal Cartridge Syringe","Device: Mandibular Block Anesthesia with a Metal Cartridge Syringe",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","Digital Anesthesia with SleeperOne 5","For both maxillary and mandibular teeth, 1.7 mL of Ultracaine D-S Fort carpule (4% articaine with 1:200,000 epinephrine) was administered in two stages (gingival and intraosseous injection) using a computer-controlled intraosseous anesthesia system with a 30-gauge, 9 mm Effitec needle.",[9],[28],"SleeperOne 5",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Infiltration Anesthesia with a Metal Cartridge Syringe","For maxillary teeth, buccal infiltration is performed using a metal carpule syringe and a 30G, 16 mm Effitec needle (Dental Hi Tec, France); after aspiration, Ultracaine D-S Fort is slowly injected over 1 minute.",[15],[34],"Supraperiosteal Anesthesia",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Mandibular Block Anesthesia with a Metal Cartridge Syringe","For mandibular teeth, the injection site is dried, and a 27G, 35 mm Effitec needle (Dental Hi Tec, France) is inserted between the pterygomandibular raphe and internal oblique ridge, aligned with contralateral molars. After aspiration, Ultracaine D-S Fort is slowly injected over 1 minute using a traditional metal carpule syringe, following the standard mandibular block technique.",[15],[40],"IANB",[42],{"name":43,"affiliation":44,"role":45},"Emin C Tümen","Dicle Universty","STUDY_DIRECTOR",[47,53],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Hasan S Şener","CONTACT","+905301507384",null,"dtsaidsener@gmail.com",{"name":54,"role":49,"phone":55,"phoneExt":51,"email":56},"Merve Güngör","+905301556358","dt.mervegunes92@gmail.com",[58],{"facility":59,"status":51,"city":60,"state":51,"zip":61,"country":62,"countryCode":51,"cosmosGeoPoint":63,"geoPoint":68,"contacts":51},"Dicle University Faculty of Dentistry, Department of Pediatric Dentistry","Diyarbakır","21300","Turkey (Türkiye)",{"type":64,"coordinates":65},"Point",[66,67],40.21721,37.91363,{"lat":67,"lon":66},{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"PRINCIPAL_INVESTIGATOR","Hasan Said Şener","Research Asisstant","100604974","pain-and-anxiety-in-pediatric-dentistry-computer-controlled-vs-traditional-anesthesia-100604974",false,"NCT07156487","Pain and Anxiety in Pediatric Dentistry: Computer-Controlled vs. Traditional Anesthesia","The Evaluation of the Effects of Computer-controlled Electronic Anesthesia Systems and Traditional Local Anesthesia Techniques, Along With Different Anesthetic Agents, on Pain and Anxiety Levels During Dental Treatments in Pediatric Patients: A Randomized Controlled Clinical Study","Inclusion Criteria:\n\n* Patients classified as ASA I in general systemic health\n\n  * Children between 7 and 10 years of age\n  * Absence of any syndromic condition\n  * No physical or mental disability\n  * No prior dental treatment experience\n  * Frankl Behavior Rating Scale Class III or IV\n  * Presence of carious lesions limited to less than one-third of the buccolingual distance between cusp tips on the occlusal surfaces of primary or permanent molars on both sides\n  * Radiographic evidence of caries involving up to half of the dentin thickness with intact dentin at the pulp-dentin border in primary or permanent molars on both sides\n  * Teeth on both sides responding positively to pulp vitality tests, with no periradicular pathology or significant widening of the lamina dura on periapical radiographs\n\nExclusion Criteria:\n\n* Patients with mild or severe systemic diseases or those undergoing medical treatment\n\n  * Patients younger than 7 or older than 10 years of age\n  * Uncooperative or noncompliant patients classified as Class I or Class II according to the Frankl Behavior Rating Scale\n  * Patients requiring urgent dental treatment\n  * Patients with wide carious lesions extending beyond one-third of the buccolingual distance between cusp tips on the occlusal surfaces\n  * Patients with carious lesions limited to less than one-third of the buccolingual width only on one side of the jaw\n  * Teeth with carious lesions not reaching half of the dentin thickness on radiographic evaluation or lacking intact dentin at the pulp border\n  * Teeth that do not respond positively to pulp vitality tests, or that show periradicular lesions or marked widening of the lamina dura on periapical radiographs",true,"ALL","7 Years","10 Years",{"count":85,"type":86},84,"ESTIMATED","INTERVENTIONAL",[89],"NA","The purpose of this clinical study is to evaluate how different local anesthesia techniques affect pain and anxiety levels in children undergoing dental treatment. Specifically, the study compares traditional syringe-based anesthesia with a computer-controlled local anesthesia system.\n\nThe study seeks to answer the following question: Which combination of anesthesia technique is most effective in reducing pain and anxiety in pediatric dental patients?\n\nBy understanding the impact of these variables, the study aims to help dental professionals choose the most appropriate anesthesia approach to improve the comfort and emotional well-being of children during dental procedures.",[92,93,94,95],"Traditional Local Anesthesia","Computer-controlled Electronic Anesthesia","Dental Anxiety","Anxiety in Children",[97,98,99],"Pediatric Dentistry","Injections, Intraosseous","Dental Instruments","NOT_YET_RECRUITING","2025-09-01",{"date":103,"type":104},"2025-09-05","ACTUAL",{"date":106,"type":86},"2025-10",{"date":108,"type":86},"2026-03",{"name":5,"class":6},1]