[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635029":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":50,"centralContacts":51,"locations":61,"responsibleParty":76,"collaborators":80,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":50,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":50,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":64,"whyStopped":50,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Istanbul University","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Anesthesia","ACTIVE_COMPARATOR","Infiltration anesthesia using conventional syringe prior to tooth extraction.",[13],"Drug: Traditional Local Anesthesia (Conventional Syringe)",{"label":15,"type":16,"description":17,"interventionNames":18},"Aromatherapy + Conventional Anesthesia","EXPERIMENTAL","Aromatherapy via inhalation (lavender + orange oil) using diffuser prior to extraction\n\nFollowed by conventional anesthesia",[19],"Other: Aromatherapy (Lavender or Orange Essential Oil)",{"label":21,"type":16,"description":22,"interventionNames":23},"Digital Anesthesia Group (SleeperOne 5)","Participants will not receive aromatherapy. Local anesthesia will be administered using the SleeperOne 5 computerized digital anesthesia system, which regulates injection pressure and flow rate through its resistance analysis technology.",[24],"Device: Digital Local Anesthesia (SleeperOne 5)",{"label":26,"type":16,"description":27,"interventionNames":28},"Combination Group (Aromatherapy + Digital Local Anesthesia)","Participants in this group will receive both aromatherapy (lavender or orange essential oil) and digital local anesthesia delivered via the SleeperOne 5 device.",[19,24],[30,37,43],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Traditional Local Anesthesia (Conventional Syringe)","Local anesthesia will be administered using a conventional dental syringe with a standard injection technique. No computerized delivery system will be used.",[9],[36],"Standard syringe anesthesia",{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Aromatherapy (Lavender or Orange Essential Oil)","Participants will receive inhalational aromatherapy using lavender or orange essential oil prior to the dental procedure.",[15,26],[42],"Inhalational aromatherapy",{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DEVICE","Digital Local Anesthesia (SleeperOne 5)","Local anesthesia will be administered using the SleeperOne 5 computerized anesthesia delivery device (Dentalhitec, France).",[26,21],[49],"Computer-controlled local anesthesia",null,[52,57],{"name":53,"role":54,"phone":55,"phoneExt":50,"email":56},"Arzu Pınar Erdem, professor","CONTACT","+90 532 543 14 53","apinar@istanbul.edu.tr",{"name":58,"role":54,"phone":59,"phoneExt":50,"email":60},"Yonca Bircan Erçin","+90 543 599 04 94","ybnrcn_2000@hotmail.com",[62],{"facility":63,"status":64,"city":65,"state":65,"zip":66,"country":67,"countryCode":50,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Istanbul University, Faculty of Dentistry, Department of Pediatric Dentistry","RECRUITING","Istanbul","34093","Turkey (Türkiye)",{"type":69,"coordinates":70},"Point",[71,72],28.94966,41.01384,{"lat":72,"lon":71},[75],{"name":58,"role":54,"phone":59,"phoneExt":50,"email":60},{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"SPONSOR_INVESTIGATOR","Arzu Pınar Erdem","Professor",[81],{"name":82,"class":83},"Bilimsel Araştirma Projeleri Birimi, Istanbul Üniversitesi","UNKNOWN","100635029","effectiveness-of-aromatherapy-and-digital-anesthesia-in-managing-dental-anxiety-and-pain-in-children-100635029",false,"NCT07547371","Effectiveness of Aromatherapy and Digital Anesthesia in Managing Dental Anxiety and Pain in Children","Assessing the Effectiveness of Aromatherapy and Digital Anesthesia Techniques for the Management of Tooth-Extraction-Related Dental Anxiety and Pain in Children","Inclusion Criteria:\n\nParticipants will be recruited from the Department of Pediatric Dentistry at Istanbul University Faculty of Dentistry who meet the following criteria:\n\nChildren aged 6-12 years,\n\nIndicated for extraction of a mandibular primary molar without acute infection or abscess,\n\nNo use of analgesic or sedative medications within the previous 24 hours,\n\nAbsence of any systemic disease,\n\nBehavior rated as Category 2, 3, or 4 on the Frankl Behavior Rating Scale,\n\nVoluntary agreement to participate in the study.\n\nExclusion Criteria:\n\nChildren with a history of systemic disease or those taking medications on a regular basis,\n\nKnown allergy to local anesthetic agents or essential oils,\n\nUse of analgesic or sedative medications within the previous 24 hours,\n\nChildren with asthma, chronic obstructive pulmonary disease (COPD), upper respiratory tract infections, or any respiratory condition that may increase sensitivity to inhalational therapies,\n\nChildren rated as Category 1 on the Frankl Behavior Rating Scale, indicating an inability to cooperate,\n\nTeeth indicated for extraction due to acute infection or abscess,\n\nPatients with teeth presenting mobility, ankylosis, or root resorption exceeding one-third of the root length.",true,"ALL","6 Years","12 Years",{"count":96,"type":97},132,"ESTIMATED","INTERVENTIONAL",[100],"NA","The goal of this clinical study is to learn whether aromatherapy and digital anesthesia are effective in reducing dental anxiety and pain during tooth extraction in children. The study also aims to understand how these methods influence children's comfort and cooperation during treatment.\n\nThe main questions this study aims to answer are:\n\nDo aromatherapy (lavender and orange essential oils) and digital anesthesia reduce dental anxiety and pain during tooth extraction in children?\n\nAre these methods more comfortable and less stressful for pediatric patients compared to traditional anesthesia techniques?\n\nDoes digital anesthesia improve cooperation and ease of management during dental treatment?\n\nResearchers will compare aromatherapy and digital anesthesia with conventional anesthesia methods to determine whether these techniques make the extraction process easier and more comfortable for children.\n\nParticipants will:\n\nReceive either aromatherapy, digital anesthesia, conventional anesthesia, or a combination depending on the study group\n\nUndergo tooth extraction under controlled clinical conditions\n\nBe evaluated before, during, and after treatment using standardized pain and anxiety scales\n\nProvide post-treatment feedback along with their parents regarding comfort and anxiety levels\n\nThis study may help identify gentler and more child-friendly approaches to managing anxiety and pain during pediatric dental procedures.",[103,104,105],"Pain","Dental Anxiety","Tooth Extraction",[107,108,109,110,111],"Dental anxiety","Dental pain","Primary molar extraction","Aromatherapy","Computer-controlled anesthesia","2026-04-16",{"date":114,"type":115},"2026-04-23","ACTUAL",{"date":117,"type":115},"2025-12-11",{"date":119,"type":97},"2026-07-04",{"name":78,"class":6},1]