[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632839":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":35,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":35,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":35,"enrollmentInfo":73,"targetDuration":35,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":89,"whyStopped":35,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nanozyme treatment","EXPERIMENTAL","After access preparation with sterile burs and sterile saline irrigation and working length determination, 2 mL of a mixture of Ferumoxytol (6mg\u002FmL)\u002FH2O2(3%) will be introduced into the canal. The root canal systems will be instrumented with XP-Shaper rotary files, a total of 8 mL of solution will be used, and a total contact time of 10 minutes.",[13],"Drug: Nanozyme treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Sodium hypochlorite","ACTIVE_COMPARATOR","After access preparation with sterile burs and sterile saline irrigation and working length determination, 2 mL of a mixture of sodium hypochlorite (NaOCl) will be introduced into the canal. The root canal systems will be instrumented with XP-Shaper rotary files, a total of 8 mL of NaOCl solution will be used, and a total contact time of 10 minutes.",[19],"Drug: Control (Standard treatment)",[21,29],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Experimental arm: topical intra-canal irrigation with ferumoxytol (Feraheme®) diluted to 6 mg\u002FmL in 0.1 M sodium acetate, activated with 3% H₂O₂. The solution is instilled into an isolated, dried canal, physically agitated for \\~60 s to promote nanozyme activation and convective mixing, held for a brief contact time (\\\u003C10 min), then aspirated per SOP; post-treatment intracanal sterile paper-point samples are collected. Topical nanozyme mechanism (catalytic ROS generation from low-dose H₂O₂), defined low topical dose and brief contact time (non-systemic).",[9],[26,27,28],"Iron oxide nanoparticles","Feraheme","Ferumoxytol",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Control (Standard treatment)","Control arm: standard clinical irrigation with 3% sodium hypochlorite (NaOCl) using matched total volume and institutional activation method, with identical pre\u002Fpost sampling and follow-up.",[15],[34,15],"NaOCl",null,[37],{"name":38,"role":39,"phone":40,"phoneExt":35,"email":41},"Nadasinee Jaruchotiratanasakul, DDS, DScD Candidate","CONTACT","2155264666","nadaja@upenn.edu",[43],{"facility":44,"status":35,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Penn Dental Medicine, Department of Endodontics","Philadelphia","Pennsylvania","19104","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-75.16362,39.95238,{"lat":54,"lon":53},[57],{"name":58,"role":39,"phone":59,"phoneExt":35,"email":41},"Nadasinee Jaruchotiratanasakul, DDS, DScD","215-526-4666",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Bekir Karabucak","Chair and Professor of Endodontics","100632839","phase-4-nanozymes-in-endodontics-100632839",false,"NCT07518901","Nanozymes in Endodontics","Ferumoxytol Nanozymes for Biofilm Disruption: A Clinical Study","Inclusion Criteria:\n\n1. Patients willing to participate in the study.\n2. Patients are 18 years or above.\n3. Non-contributory medical history (Patient can be seen for regular dental appointment in PDM; ASA classes I and II).\n4. Tooth requiring root canal treatment with radiographic presence of periapical radiolucency and\n\n   1. responding to thermal sensitivity testing negatively (Difluordichlormethane at 50 °C, Endo-Ice,\n   2. Coltène\u002FWhaledent Inc., Cuyahoga Falls, Ohio) or a negative response to EPT testing.\n5. Tooth with adequate remaining tooth structure for proper isolation with rubber dam.\n6. No history of previous endodontic treatment on the tooth.\n7. Teeth with single roots or multirooted teeth.\n\nExclusion Criteria:\n\n1. Self-reported pregnancy.\n2. Patients requiring antibiotic premedication prior to dental treatment.\n3. Patients with multiple drug allergies.\n4. Patients with known hypersensitivity to Ferumoxytol nanoparticles or any iron products.\n5. Patients who are scheduled for MRI for the head region within three months after Ferumoxytol nanoparticles application.\n6. Periodontal changes (pockets 3 mm, mobility Grade I, or gingival edema).\n7. Patients who cannot return for a subsequent appointment or follow-ups.\n8. Radiographic presence of resorptive processes.\n9. Cracked and fractured teeth.","ALL","18 Years",{"count":74,"type":75},72,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","The antimicrobial efficacy and healing potential of clinically approved ferumoxytol nanozymes versus the standard 3% NaOCl irrigant will be evaluated in adults undergoing endodontic treatment. Building on prior protocols that demonstrated ferumoxytol nanozymes antimicrobial activity as a root canal irrigant, ferumoxytol solution will be applied topically, assessment of clinical and radiographical findings will determine its potential as a novel disinfection and its long-term outcome.",[81,82,83],"Apical Periodontitis","Endodontic Disease","Root Canal Infection",[85,86,87,88],"Nanozymes","Root canal irrigants","Nanotechnology","iron oxide nanoparticles","NOT_YET_RECRUITING","2026-04-01",{"date":92,"type":93},"2026-04-09","ACTUAL",{"date":95,"type":75},"2026-06",{"date":97,"type":75},"2028-06",{"name":5,"class":6},1]