[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649456":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":47,"locations":56,"responsibleParty":69,"collaborators":32,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":32,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":101,"whyStopped":32,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Alanya Alaaddin Keykubat University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cryotherapy group","EXPERIMENTAL","Following standard non-surgical endodontic retreatment instrumentation, participants received final intracanal irrigation with sterile saline (0.9% NaCl) cooled to 2.5°C, 20 mL, over 5 minutes, in a single visit.",[13],"Procedure: Intracanal cryotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Following the same standard non-surgical endodontic retreatment instrumentation, participants received final intracanal irrigation with sterile saline (0.9% NaCl) at room temperature (20-22°C), 20 mL, over 5 minutes, in a single visit.",[19],"Procedure: Room-temperature saline irrigation",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Intracanal cryotherapy","Final intracanal irrigation with sterile 0.9% saline solution cooled to 2.5°C (using an ice-water bath), 20 mL administered over 5 minutes, performed after canal instrumentation during single-visit non-surgical endodontic retreatment.",[9],[27],"Cold Saline Irrigation",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Room-temperature saline irrigation","Final intracanal irrigation with sterile 0.9% saline solution at room temperature (20-22°C), 20 mL administered over 5 minutes, performed after canal instrumentation during single-visit non-surgical endodontic retreatment - identical protocol to the cryotherapy group except for irrigant temperature.",[15],null,[34,38,42,45],{"name":35,"affiliation":36,"role":37},"Hatice BÜYÜKÖZER ÖZKAN, Associate Professor","Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Endodontics","STUDY_DIRECTOR",{"name":39,"affiliation":40,"role":41},"Bilge Karcı, Associate Professor","Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Periodontology","PRINCIPAL_INVESTIGATOR",{"name":43,"affiliation":44,"role":41},"Ertan Küçüksayan, Associate Professor","Alanya Alaaddin Keykubat University, Faculty of Medicine, Department of Biochemistry",{"name":46,"affiliation":36,"role":41},"Gizem Pelin Yoldaş, Research Assistant",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":32,"email":52},"Hatice Büyüközer Özkan, Associate Professor","CONTACT","+90 530 971 02 52","hatice.ozkan@alanya.edu.tr",{"name":46,"role":50,"phone":54,"phoneExt":32,"email":55},"+90 5462446097","pelin.yoldas@alanya.edu.tr",[57],{"facility":58,"status":32,"city":59,"state":60,"zip":61,"country":62,"countryCode":32,"cosmosGeoPoint":63,"geoPoint":68,"contacts":32},"Alanya Alaaddin Keykubat University, Faculty of Dentistry","Antalya","ALANYA","07400","Turkey (Türkiye)",{"type":64,"coordinates":65},"Point",[66,67],30.69556,36.90812,{"lat":67,"lon":66},{"type":41,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Hatice BÜYÜKÖZER ÖZKAN","Associate Professor","100649456","cryotherapy-pge2-ngf-levels-and-pain-after-endodontic-retreatment-100649456",false,"NCT07733700","Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment","Evaluation of the Relationship Between PGE2, NGF, and Postoperative Pain in Patients With and Without Intracanal Cryotherapy in Single-visit Endodontic Retreatment","ICE-PAIN","Inclusion Criteria:\n\n* Age 18-65 years, systemically healthy individuals (ASA I-II)\n* Single-rooted mandibular premolar teeth with a previous root canal treatment, requiring non-surgical retreatment due to asymptomatic apical periodontitis\n* Presence of periapical radiolucency (Periapical Index \\[PAI\\] ≥ 3)\n* No antibiotic use within the past 1 month\n* Willing to participate and has signed the informed consent form\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Uncontrolled diabetes mellitus (HbA1c \\> 7%), diagnosed autoimmune disease, or receiving immunosuppressive therapy\n* Systemic corticosteroid use within the past 3 months\n* Body mass index (BMI) greater than 35 kg\u002Fm²\n* Presence of acute infection (e.g., acute apical abscess or cellulitis)\n* Conditions precluding retreatment, including advanced periodontal breakdown (clinical attachment loss \\> 5 mm), root resorption, perforation, or advanced canal calcification\n* Absence of an opposing (antagonist) tooth resulting in lack of functional occlusal contact\n* Diagnosed chronic pain syndrome or currently receiving active psychiatric treatment\n* Smoking more than 10 cigarettes per day\n* Use of analgesics or NSAIDs within the past 24 hours\n* Antibiotic use within the past 1 month","ALL","18 Years","65 Years",{"count":84,"type":85},100,"ESTIMATED","INTERVENTIONAL",[88],"NA","This prospective, randomized, controlled, single-blind, parallel-group clinical trial evaluates whether intracanal cryotherapy reduces postoperative pain and inflammatory biomarker levels following single-visit endodontic retreatment of teeth with asymptomatic apical periodontitis. A total of 100 patients (18-65 years, systemically healthy, ASA I-II) requiring non-surgical retreatment of a single-rooted mandibular premolar tooth will be randomly assigned via computer-generated randomization to one of two equal groups (n=50 each): a cryotherapy group, receiving intracanal final irrigation with sterile saline cooled to 2.5°C for 5 minutes, and a control group, receiving the same irrigation protocol with saline at room temperature (20-22°C). Salivary nerve growth factor (NGF) and gingival crevicular fluid (GCF) prostaglandin E2 (PGE2) levels will be measured by ELISA at baseline (T0), 24 hours (T1), and 72 hours (T2). Postoperative pain will be assessed using a visual analog scale (VAS, 0-100 mm) at 6, 12, 24, 48, and 72 hours and on day 7, with the 24-hour VAS score as the primary comparison point. Rescue analgesic (paracetamol) consumption will also be recorded and compared between groups. The study aims to determine whether intracanal cryotherapy lowers postoperative pain and biomarker levels compared to standard-temperature irrigation, and to evaluate the correlation between PGE2\u002FNGF levels and pain intensity.",[91,92,93],"Asymptomatic Apical Periodontitis","Endodontic Retreatment","Cryotherapy",[95,96,97,98,92,99,100],"Intracanal Cryotherapy","Postoperative Pain","Prostaglandin E2","Nerve Growth Factor","Gingival Crevicular Fluid","Saliva Biomarkers","NOT_YET_RECRUITING","2026-07-28",{"date":104,"type":105},"2026-07-29","ACTUAL",{"date":107,"type":85},"2026-08-01",{"date":109,"type":85},"2027-09-01",{"name":5,"class":6},1]