[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634665":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":36,"collaborators":26,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":26,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":69,"overallStatus":82,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":26},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CTZ Paste (NIET)","EXPERIMENTAL","Participants will receive non-instrumental endodontic treatment (NIET) using CTZ paste in a single visit for the management of necrotic primary molars in an emergency dental care setting.",[13],"Drug: CTZ Paste",{"label":15,"type":16,"description":17,"interventionNames":18},"ZOE Pulpectomy","ACTIVE_COMPARATOR","Conventional pulpectomy involving mechanical instrumentation of root canals, irrigation, and obturation with zinc oxide-eugenol paste.",[19],"Procedure: ZOE Pulpectomy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","CTZ Paste","CTZ paste is an antimicrobial intracanal medication used in non-instrumental endodontic treatment. The paste is placed into the pulp chamber without mechanical instrumentation, aiming to disinfect the root canal system based on the principles of lesion sterilization and tissue repair (LSTR).",[9],null,{"type":28,"name":15,"description":17,"armGroupLabels":29,"otherNames":26},"PROCEDURE",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Camilla E Santos, phD","CONTACT","+55 11 26488046","camilla.santos@usp.br",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Isabelle Elise Squillace Mendes","Principal investigator","100634665","early-phase-1-chloramphenicol-tetracycline-zinc-oxide-and-eugenol-paste-ctz-paste-for-emergency-dental-treatment-in-public-health-settings-a-randomized-trial-100634665",false,"NCT07542639","Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) for Emergency Dental Treatment in Public Health Settings: A Randomized Trial","Clinical and Radiographic Efficacy of Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) in the Context of Emergency Dental Treatments in Brazilian Public Health: Randomized Clinical Trial","CTZ- emergency","Inclusion Criteria:\n\n* Pediatric patients presenting with:\n* Irreversible pulpitis in primary molars;\n* Pulp necrosis, with or without abscess, in primary molars.\n* Primary molars with sufficient remaining tooth structure to allow endodontic treatment.\n* Primary teeth in which the permanent successor tooth germ presents developmental stages compatible with Nolla stages 1 to 7, defined as:\n\nStage 1: Presence of bony crypt with no evidence of calcification; Stage 2: Initial calcification, with appearance of radiopaque points in the crown region; Stage 3: Approximately one-third of crown formation; Stage 4: Approximately two-thirds of crown formation; Stage 5: Crown almost complete, without full calcification; Stage 6: Crown completely formed, without initiation of root formation; Stage 7: Initial root formation.\n\n* Clinical and radiographic conditions indicating feasibility of tooth maintenance through endodontic treatment, including:\n* Permanent successor in developmental stages prior to Nolla Stage 8;\n* Preservation of the bony crypt.\n\nExclusion Criteria:\n\n* Pediatric patients presenting with:\n* Reversible pulpitis;\n* Indication for endodontic treatment in permanent teeth.\n* History of allergy or hypersensitivity to any components of the obturation materials (e.g., CTZ paste or zinc oxide-eugenol).\n* Clinical conditions that prevent adequate management in an outpatient setting.\n* Primary teeth in which the permanent successor:\n* Is in advanced developmental stages (Nolla Stage 8 or higher), and\u002For\n* Presents disruption of the bony crypt, contraindicating endodontic treatment.\n* Teeth presenting internal root resorption that compromises the feasibility of endodontic treatment.","ALL","2 Years","11 Years",{"count":52,"type":53},110,"ESTIMATED","INTERVENTIONAL",[56],"EARLY_PHASE1","The treatment of pulpal diseases in primary teeth represents a significant challenge in public health, particularly in emergency dental care settings, where factors such as limited clinical time, low child cooperation, and structural constraints directly impact treatment effectiveness. In these contexts, conventional pulpectomy using zinc oxide-eugenol (ZOE), although effective, may present operational limitations that restrict its large-scale applicability in public health systems.\n\nIn this scenario, non-instrumental endodontic treatment (NIET), based on the concept of Lesion Sterilization and Tissue Repair (LSTR), has emerged as a simplified alternative. Among the available options, CTZ paste shows potential for single-visit application, reducing clinical time and technical complexity.\n\nThis study aims to evaluate the clinical and radiographic non-inferiority of CTZ paste compared to conventional pulpectomy with ZOE in primary molars with pulp necrosis, with or without abscess or fistula, treated in emergency dental care settings.\n\nThis is a randomized, pragmatic, controlled, non-inferiority clinical trial conducted at a single center, with clinical and radiographic follow-up at 3, 6, and 12 months. Participants will be allocated into two groups: (1) NIET with CTZ paste and (2) conventional pulpectomy with ZOE.\n\nPrimary outcomes include pain resolution and absence of clinical signs of infection. Secondary outcomes include radiographic success, clinical time, child behavior (Frankl Scale), need for retreatment, and oral health-related quality of life.\n\nThe findings are expected to provide robust evidence regarding the effectiveness of CTZ paste under real-world clinical conditions, contributing to the development of more accessible and effective protocols within public health systems, with the potential to expand access to conservative treatment and reduce early tooth extractions in pediatric dentistry.",[59,60,61,62,63,64,65,66,67,68],"Pulp Disease, Dental","Pulp Necrosis","Pulp Therapy in Primary Molars","Primary Teeth","Pulpectomy","Endodontics","Dental Care for Children","Treatment Outcome","Quality of Life","Health Services Accessibility",[70,71,72,73,74,75,76,77,78,79,80,81],"pulpectomy","pulpotomy","CTZ paste","NIET","Non-instrumental endodontic treatment","LSTR","Lesion sterilization and tissue repair","Endodontic infection","dental abscess","Fistula","Emergency dental treatment","Public health dentistry","NOT_YET_RECRUITING","2026-05-07",{"date":85,"type":86},"2026-05-12","ACTUAL",{"date":88,"type":53},"2026-06-08",{"date":90,"type":53},"2028-02-28",{"name":5,"class":6}]