NCT07542639

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for early_phase_1

Timeline
21mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 8, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 14, 2026

Last Update Submit

April 14, 2026

Conditions

Pulp Disease, DentalPulp NecrosisPulp Therapy in Primary MolarsPrimary TeethPulpectomyEndodonticsDental Care for ChildrenTreatment OutcomeQuality of LifeHealth Services Accessibility

Keywords

pulpectomypulpotomyCTZ pasteNIETNon-instrumental endodontic treatmentLSTRLesion sterilization and tissue repairEndodontic infectiondental abscessFistulaEmergency dental treatmentPublic health dentistry

Outcome Measures

Primary Outcomes (1)

  • Pain Resolution and Clinical Infection Control

    Resolution of dental pain and absence of clinical signs of infection following emergency endodontic treatment in primary molars. Pain will be assessed using a validated pain scale (e.g., Wong-Baker Faces Pain Scale), and infection control will be determined by the absence of clinical signs such as swelling, fistula, abscess, or pathological mobility. The outcome will also consider the need for unplanned additional interventions as an indicator of treatment failure.

    Up to 7 days post-treatment (primary endpoint), with follow-up assessments at 3, 6, and 12 months.

Secondary Outcomes (1)

  • Child Behaviour and Oral Health-Realated Quality of Life

    Baseline and 3, 6, and 12 months after treatment

Study Arms (2)

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.

Drug: CTZ Paste

ZOE Pulpectomy

ACTIVE COMPARATOR

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

Procedure: ZOE Pulpectomy

Interventions

CTZ PasteDRUG

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).

CTZ Paste (NIET)
ZOE PulpectomyPROCEDURE

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

ZOE Pulpectomy

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients presenting with:
  • Cases diagnosed with irreversible pulpitis in primary molars; Cases of pulp necrosis, with or without abscess, in primary molars. Primary molars with sufficient remaining tooth structure to allow endodontic treatment.
  • Primary teeth in which the permanent successor tooth germ presents developmental stages compatible with stages 1 to 6 of Nolla, corresponding to early stages of odontogenesis, defined as follows:
  • Stage 1: Presence of bony crypt with no evidence of calcification; Stage 2: Initial calcification, with the 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. Teeth will also be included when the permanent successor shows development compatible with Nolla Stage 7.
  • Clinical and radiographic conditions indicating the feasibility of maintaining the tooth through endodontic treatment, defined as:
  • Permanent successor in developmental stages prior to Nolla Stage 8 (i.e., before advanced root formation), and/or Preservation of the bony crypt.

You may not qualify if:

  • Pediatric patients presenting with:
  • Cases diagnosed with reversible pulpitis; Indication for endodontic treatment in permanent teeth. History of allergy or hypersensitivity to any of the components used in the obturation materials (e.g., CTZ paste or zinc oxide-eugenol).
  • Clinical conditions that prevent adequate management in an outpatient setting. Primary teeth in which the permanent successor is in advanced stages of development (Nolla Stage 8 or higher), and/or with evidence of disruption of the bony crypt, contraindicating endodontic treatment.
  • Teeth presenting internal root resorption that compromises the feasibility of endodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (28)

  • Kasidid R, et al. Antimicrobial efficacy of chlorhexidine and sodium hypochlorite: systematic review and meta-analysis. J Endod. 2020.

    BACKGROUND

  • Oliveira MFB, et al. Antimicrobial action of chlorhexidine in root canal systems. Braz Oral Res. 2017;31:e15.

    BACKGROUND

  • Brasil. Ministério da Saúde. Avaliação da sobrecarga dos cuidadores: Escala de Zarit. Brasília; 2013.

    BACKGROUND

  • Siegl RMC, et al. Analysis of two endodontic techniques in primary molars with fistula. RGO. 2015;63(2):187-194.

    BACKGROUND

  • Neves FG, et al. Cytotoxicity profile of endodontic irrigants: a systematic review. J Appl Oral Sci. 2018;26:e20170206.

    BACKGROUND

  • Silva AR, et al. Comparative evaluation of chemical irrigants in intracanal bacterial reduction. Rev Odontol Bras. 2014;23(2):95-102.

    BACKGROUND

  • Ferraz CCR. In vitro evaluation of chlorhexidine gel as an endodontic irrigant [thesis]. UNICAMP; 1999.

    BACKGROUND

  • Gomes BPFA, et al. Chlorhexidine in endodontics: antimicrobial activity against Enterococcus faecalis. Int Endod J. 2001;34(6):424-428.

    BACKGROUND

  • Hülsmann M, Hahn W. Complications during root canal irrigation. Int Endod J. 2000;33(3):186-193.

    BACKGROUND

  • Zehnder M. Root canal irrigants. J Endod. 2006;32(5):389-398.

    BACKGROUND

  • Tanalp J, Güngör T. Apical extrusion of debris: a literature review. Int Endod J. 2014;47(3):211-221.

    BACKGROUND

  • American Academy of Pediatric Dentistry. Behavior guidance for the pediatric dental patient. Chicago: AAPD; 2023

    BACKGROUND

  • Klingberg G, Broberg AG. Dental fear/anxiety and behavior management problems in children: a review. Int J Paediatr Dent. 2007;17(6):391-406.

    BACKGROUND

  • Lin PY, Huang SH, Chang HJ, Chi LY. Effect of rubber dam usage on survival rate of teeth receiving root canal treatment. J Endod. 2014;40(11):1733-1737.

    BACKGROUND

  • American Association of Endodontists. Guide to Clinical Endodontics. 6th ed. Chicago: AAE; 2020.

    BACKGROUND

  • European Society of Endodontology. Quality guidelines for endodontic treatment: consensus report. Int Endod J. 2006;39(12):921-930.

    BACKGROUND

  • Oliveira NM. Patient-centered outcomes in non-instrumental endodontic treatment with CTZ paste in primary molars: multicenter randomized clinical trial [Master's dissertation]. University of São Paulo; 2023.

    BACKGROUND

  • Santos PS, Oliveira NM, Ramos T, et al. Efficacy of the non-instrumentation endodontic treatment with CTZ paste in primary molars: protocol of a multicenter randomized clinical trial. Res Soc Dev. 2022;11(16):e37140.

    BACKGROUND

  • Pereira RS, et al. Comparative evaluation of non-instrumental endodontic treatment with CTZ paste in primary molars. Pediatr Dent J. 2022;32(1):21-28.

    BACKGROUND

  • Traumann RR, Maia LC. Alternative endodontic treatments for primary teeth: a systematic review. Int J Paediatr Dent. 2021;31(5):661-674.

    BACKGROUND

  • Costa FS, et al. Behavior of children during dental treatment and related factors. Rev Paul Pediatr. 2018;36(2):154-160.

    BACKGROUND

  • Gonçalves LDC, et al. Clinical and radiographic evaluation of CTZ paste for endodontic treatment of necrotic primary teeth. Braz Oral Res. 2017;31:e30.

    BACKGROUND

  • Mendes FM, et al. Endodontic treatment of primary teeth: clinical success using simplified techniques. Int J Paediatr Dent. 2012;22(1):77-83.

    BACKGROUND

  • Santos BD, Lima FF, Pereira LC. Radiographic and histological aspects of zinc oxide-eugenol paste in primary teeth. Rev Paul Odontol. 1999;21(2):15-22.

    BACKGROUND

  • Primosch RE, Barnett R. Endodontic treatment for primary teeth: clinical and radiographic evaluation. Pediatr Dent. 1975;7(1):1-5.

    BACKGROUND

  • Fuks AB. Pulp therapy for the primary and young permanent dentitions. Dent Clin North Am. 2014;58(1):159-173

    BACKGROUND

  • Citation: Cappiello J. Tratamento endodôntico em dentes decíduos utilizando pasta antibiótica CTZ. J Dent Child. 1964;31(2):137-141.

    BACKGROUND

  • de Deus Moura Lde F, de Lima Mde D, Lima CC, Machado JI, de Moura MS, de Carvalho PV. Endodontic Treatment of Primary Molars with Antibiotic Paste: A Report of 38 Cases. J Clin Pediatr Dent. 2016;40(3):175-7. doi: 10.17796/1053-4628-40.3.175.

    PMID: 27472562BACKGROUND

Related Links

MeSH Terms

Conditions

Dental Pulp DiseasesDental Pulp NecrosisPeriapical AbscessFistula

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAbscessSuppurationInfectionsPeriapical PeriodontitisPeriapical DiseasesJaw DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisPathological Conditions, Anatomical

Central Study Contacts

Camilla E Santos, phD

CONTACT

+55 11 26488046camilla.santos@usp.br

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master' student

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 21, 2026

Study Start (Estimated)

June 8, 2026

Primary Completion (Estimated)

December 20, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual Participant Data (IPD) will not be shared. The decision not to share IPD is based on ethical and regulatory considerations, as the study involves pediatric participants and includes potentially sensitive clinical data. Data confidentiality and participant privacy will be strictly maintained in accordance with applicable data protection regulations and institutional ethics committee requirements. Only aggregated data will be reported in scientific publications and presentations. No individual-level data will be made publicly available.