CTZ Paste for Emergency Dental Treatment in Public Health Settings: A Randomized Trial
Summary
The NIH has registered a randomized, pragmatic, controlled, non-inferiority clinical trial (NCT07542639) evaluating the clinical and radiographic non-inferiority of CTZ paste compared to conventional pulpectomy with zinc oxide-eugenol (ZOE) in primary molars with pulp necrosis. The single-center trial will follow participants at 3, 6, and 12 months, measuring pain resolution and absence of clinical signs of infection as primary outcomes.
What changed
The NIH registered a new clinical trial, NCT07542639, titled 'CTZ Paste for Emergency Dental Treatment in Public Health Settings: A Randomized Trial.' The study is an Early Phase 1 randomized, pragmatic, controlled, non-inferiority clinical trial conducted at a single center, comparing non-instrumental endodontic treatment (NIET) with CTZ paste against conventional pulpectomy with zinc oxide-eugenol (ZOE) in primary molars with pulp necrosis. Participants will be followed clinically and radiographically at 3, 6, and 12 months, with primary outcomes of pain resolution and absence of clinical signs of infection.
Healthcare providers and clinical investigators in public health emergency dental settings should note this trial as a potential simplified alternative approach to pulpectomy in children. The study focuses on reducing clinical time and technical complexity in resource-constrained settings, which may inform future treatment protocols if non-inferiority is demonstrated.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
CTZ Paste for Emergency Dental Treatment in Public Health Settings: A Randomized Trial
Early Phase 1 NCT07542639 Kind: EARLY_PHASE1 Apr 21, 2026
Abstract
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.
In 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.
This 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.
This 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.
Primary outcomes include pain resolution and absence of clinical signs of infection. Secondary outcomes include radiographic success, clinical time, child behavi...
Conditions: 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
Interventions: CTZ Paste, ZOE Pulpectomy
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.