Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) for Emergency Dental Treatment in Public Health Settings: A Randomized Trial

Summary

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 behavior (Frankl Scale), need for retreatment, and oral health-related quality of life.

The 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.

Conditions

• Pulpectomy
• Endodontics
• Pulp Disease, Dental
• Pulp Necrosis
• Pulp Therapy in Primary Molars
• Primary Teeth
• Dental Care for Children
• Treatment Outcome
• Quality of Life
• Health Services Accessibility

Interventions

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).

PROCEDURE

ZOE Pulpectomy

Conventional pulpectomy involving mechanical instrumentation of root canals, irrigation, and obturation with zinc oxide-eugenol paste.

Sponsors & Collaborators

• University of Sao Paulo

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

11 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-08

Primary Completion

2027-12-20

Completion

2028-02-28