[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632721":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":12,"centralContacts":41,"locations":47,"responsibleParty":63,"collaborators":12,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":12,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":12,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":49,"whyStopped":12,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Ondokuz Mayıs University","OTHER",[8,13,16,19,22,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Buccal Infiltration With Vasoconstrictor","NO_INTERVENTION","Participants will receive buccal infiltration anesthesia using 2.0 mL lidocaine with epinephrine administered to the vestibular sulcus of the target mandibular incisor. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores during endodontic treatment.",null,{"label":14,"type":10,"description":15,"interventionNames":12},"Buccal Infiltration Without Vasoconstrictor","Participants will receive buccal infiltration anesthesia using 2.0 mL lidocaine without vasoconstrictor administered to the vestibular sulcus of the target mandibular incisor. Anesthetic success will be assessed using electric pulp testing and intraoperative pain scoring.",{"label":17,"type":10,"description":18,"interventionNames":12},"Buccal and Lingual Infiltration With Vasoconstrictor","Participants will receive both buccal and lingual infiltration anesthesia using lidocaine with epinephrine administered to the vestibular and lingual aspects of the mandibular incisor. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores.",{"label":20,"type":10,"description":21,"interventionNames":12},"Buccal and Lingual Infiltration Without Vasoconstrictor","Participants will receive buccal and lingual infiltration anesthesia using lidocaine without vasoconstrictor administered to the vestibular and lingual regions of the mandibular incisor. Pain response and anesthetic success will be recorded during treatment.",{"label":23,"type":24,"description":25,"interventionNames":26},"Buccal Infiltration With Vasoconstrictor and Cryotherapy","EXPERIMENTAL","Participants will receive intraoral cryotherapy applied to the vestibular sulcus for approximately 5 minutes followed by buccal infiltration anesthesia using lidocaine with epinephrine. Anesthetic success and pain response will be assessed during endodontic procedures.",[27],"Other: Cryotherapy",{"label":29,"type":24,"description":30,"interventionNames":31},"Buccal Infiltration Without Vasoconstrictor and Cryotherapy","Participants will receive intraoral cryotherapy applied to the vestibular sulcus for approximately 5 minutes followed by buccal infiltration anesthesia using lidocaine without vasoconstrictor. Pain levels and anesthetic success will be recorded.",[27],{"label":33,"type":24,"description":34,"interventionNames":35},"Buccal and Lingual Infiltration With Cryotherapy","Participants will receive intraoral cryotherapy followed by buccal and lingual infiltration anesthesia using lidocaine with epinephrine. Anesthetic efficacy will be evaluated using electric pulp testing and patient-reported pain scores during treatment.",[27],[37],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":12},"Cryotherapy","Intraoral cryotherapy will be applied using small ice packs wrapped in sterile gauze and placed into the vestibular sulcus adjacent to the target mandibular incisor. Participants will be instructed to maintain the ice pack in position for approximately 5 minutes prior to the anesthetic procedure. If discomfort occurs, participants will be allowed to briefly remove the ice pack and reapply it once comfort is restored. This intervention is intended to induce local vasoconstriction and reduce nerve conduction to enhance anesthetic efficacy.",[23,29,33],[42],{"name":43,"role":44,"phone":45,"phoneExt":12,"email":46},"Cangül Keskin, PhD DDS","CONTACT","0905414203909","cangul.keskin@omu.edu.tr",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":12,"country":52,"countryCode":12,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Samsun","Atakum","Turkey (Türkiye)",{"type":54,"coordinates":55},"Point",[56,57],36.3361,41.27976,{"lat":57,"lon":56},[60],{"name":43,"role":44,"phone":61,"phoneExt":62,"email":46},"03623121919","8254",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Cangül Keskin","Prof","100632721","phase-4-intraoral-cryotherapy-on-anesthetic-efficacy-in-mandibular-incisors-100632721",false,"NCT07517367","Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisors","Evaluation of the Effect of Intraoral Cryotherapy on Anesthetic Efficacy in Mandibular Incisor Teeth With Irreversible Pulpitis","Inclusion Criteria:\n\n* Adults aged 18 to 60 years\n* Classified as ASA Physical Status I or II\n* Presence of symptomatic irreversible pulpitis in a single-rooted mandibular incisor tooth\n* Preoperative pain score ≥8 on the Numerical Rating Scale (NRS) and Wong-Baker FACES scale\n* Positive response to cold test and electric pulp testing\n* Absence of periapical pathology on preoperative periapical radiograph\n* No analgesic intake within 6 hours prior to treatment\n* Ability to understand and complete pain assessment scales\n* Willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Age below 18 years or above 60 years\n* Pregnancy\n* Known allergy to local anesthetic agents\n* Diagnosis of diabetes mellitus\n* Presence of hypothyroidism\n* Diagnosis of adrenal insufficiency\n* Presence of Raynaud disease\n* Uncontrolled diabetes (HbA1c \\>7%)\n* Presence of periapical pathology detected radiographically\n* Presence of sinus tract\n* Presence of intraoral or extraoral swelling\n* Teeth diagnosed with necrotic pulp\n* Presence of referred pain from another tooth or anatomical structure","ALL","18 Years","60 Years",{"count":78,"type":79},98,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","The aim is to compare the contributions of intraoral cryotherapy and supplemental lingual infiltration anesthesia to buccal infiltration anesthesia in mandibular incisor teeth with irreversible pulpitis in terms of anesthetic efficacy, and to evaluate the effect of adding intraoral cryotherapy to buccal anesthesia on anesthetic efficacy.",[85],"Symptomatic Irreversible Pulpitis (SIP)",[87,88,89,90],"Symptomatic Irreversible Pulpitis","Mandibular Incisor","Intraoral Cryotherapy","Buccal Infiltration Anesthesia","2026-04-03",{"date":93,"type":94},"2026-04-08","ACTUAL",{"date":96,"type":94},"2025-12-31",{"date":98,"type":79},"2026-08-30",{"name":5,"class":6},1]