Pulp Disease, DentalEarly Phase 1CTZ- emergencyNCT07542639
Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) for Emergency Dental Treatment in Public Health Settings: A Randomized Trial
A Early Phase 1 study testing CTZ Paste and ZOE Pulpectomy in people with Pulp Disease, Dental and Pulp Necrosis, run by University of Sao Paulo.
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. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Pulp Disease, Dental, Pulp Necrosis, Pulp Therapy in Primary Molars
- What is being tested?
- CTZ Paste and ZOE Pulpectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 8 Jun 2026to 28 Feb 2028
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients presenting with:
- Irreversible pulpitis in primary molars;
- 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 Nolla stages 1 to 7, defined as:
- Stage 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.
Show all 9Show fewer
- Clinical and radiographic conditions indicating feasibility of tooth maintenance through endodontic treatment, including:
- Permanent successor in developmental stages prior to Nolla Stage 8;
- Preservation of the bony crypt.
Who cannot join
- Pediatric patients presenting with:
- Reversible pulpitis;
- Indication for endodontic treatment in permanent teeth.
- History of allergy or hypersensitivity to any components of 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:
Show all 9Show fewer
- Is in advanced developmental stages (Nolla Stage 8 or higher), and/or
- Presents disruption of the bony crypt, contraindicating endodontic treatment.
- Teeth presenting internal root resorption that compromises the feasibility of endodontic treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Pulpal diseases in primary teeth remain a significant challenge in public health, particularly in emergency dental care settings. These environments are often characterized by limited clinical time, reduced child cooperation, and structural constraints, all of which may compromise the effectiveness and feasibility of conventional treatments. Pulpectomy using zinc oxide-eugenol (ZOE) is widely recognized as an effective treatment for necrotic primary teeth; however, its technical complexity and time requirements may limit its applicability in high-demand public healthcare systems.
In this context, non-instrumental endodontic treatment (NIET), based on the concept of Lesion Sterilization and Tissue Repair (LSTR), has been proposed as a simplified and less time-consuming alternative. This approach aims to disinfect the root canal system using antimicrobial pastes without mechanical instrumentation. Among these, CTZ paste has shown promising results due to its antimicrobial properties, ease of use, and potential for single-visit treatment, making it particularly suitable for emergency care scenarios.
The present study is designed to evaluate whether CTZ paste is non-inferior to conventional pulpectomy with ZOE in the treatment of primary molars diagnosed with pulp necrosis, with or without the presence of abscess or fistula, in emergency dental care settings.
This is a randomized, controlled, pragmatic, non-inferiority clinical trial conducted at a single center. Eligible participants will be children presenting with necrotic primary molars requiring urgent dental treatment. After enrollment, participants will be randomly allocated into two groups: (1) non-instrumental endodontic treatment using CTZ paste and (2) conventional pulpectomy using ZOE.
All procedures will be performed according to standardized clinical protocols. Clinical and radiographic evaluations will be conducted at baseline and at follow-up intervals of 3, 6, and 12 months. Blinded outcome assessment will be performed whenever feasible to minimize bias.
The primary outcomes of this study are pain resolution and the absence of clinical signs of infection, such as swelling, fistula, or pathological mobility. Secondary outcomes include radiographic success (e.g., absence or reduction of periapical/furcal radiolucency), total clinical time required for the procedure, child behavior during treatment assessed using the Frankl Behavior Rating Scale, need for retreatment, and oral health-related quality of life.
This trial adopts a pragmatic design to reflect real-world clinical conditions, thereby enhancing the external validity and applicability of the findings. The results are expected to provide high-quality evidence regarding the effectiveness and feasibility of CTZ paste in public health settings. If non-inferiority is demonstrated, this approach may support the implementation of simplified, cost-effective, and scalable treatment protocols, contributing to improved access to conservative dental care and reducing the need for early extractions in pediatric populations.
- Conditions
- Pulp Disease, Dental, Pulp Necrosis, Pulp Therapy in Primary Molars, Primary Teeth, Pulpectomy, Endodontics
- Being tested
- CTZ Paste, ZOE Pulpectomy
- Keywords
- 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
- Medical subject headings
- Dental Pulp Diseases, Dental Pulp Necrosis, Periapical Abscess, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
ZOE PulpectomyProcedure or surgery
Conventional pulpectomy involving mechanical instrumentation of root canals, irrigation, and obturation with zinc oxide-eugenol paste.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CTZ Paste |
| ZOE Pulpectomy | Active comparator | Conventional pulpectomy involving mechanical instrumentation of root canals, irrigation, and obturation with zinc oxide-eugenol paste. Receives: Procedure: ZOE Pulpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 the Wong-Baker Faces Pain Rating Scale, a validated scale for measuring pain intensity in children. Scores range from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain." Higher scores indicate greater pain intensity (worse outcome). 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.
Measured: 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
The child's behavior and acceptance of the dental procedure during treatment will be assessed. Child behavior will be evaluated using the Frankl Behavior Rating Scale, a validated four-point scale for assessing cooperation, where 1 indicates definitely negative behavior, 2 indicates negative behavior, 3 indicates positive behavior, and 4 indicates definitely positive behavior. Higher scores indicate more positive behavior (better outcome). In addition, clinical observation of cooperation, the need for behavioral management strategies, and overall acceptability of the procedure will be recorded.
The impact of treatment on the child's and caregiver's quality of life will be assessed using validated oral health-related quality of life questionnaires, such as the Early Childhood Oral Health Impact Scale (ECOHIS). ECOHIS total scores range from 0 to 52, where higher scores indicate a greater negative impact on oral health-related quality of life (worse outcome). Subscores for Child Impact
Measured: Baseline and 3, 6, and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start8 Jun 2026 (estimated)
- Primary completion20 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Pulp Disease, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Elise Squillace Mendes, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542639
- Sponsor's protocol ID
- USaoPaulo
- Acronym
- CTZ- emergency
- Status last verified
- May 2026
- First submitted
- 14 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Ruksakiet K, Hanak L, Farkas N, Hegyi P, Sadaeng W, Czumbel LM, Sang-Ngoen T, Garami A, Miko A, Varga G, Lohinai Z. Antimicrobial Efficacy of Chlorhexidine and Sodium Hypochlorite in Root Canal Disinfection: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Endod. 2020 Aug;46(8):1032-1041.e7. doi: 10.1016/j.joen.2020.05.002. Epub 2020 May 12.
PubMed 32413440Oliveira MFB, et al. Antimicrobial action of chlorhexidine in root canal systems. Braz Oral Res. 2017;31:e15.
Brasil. Ministério da Saúde. Avaliação da sobrecarga dos cuidadores: Escala de Zarit. Brasília; 2013.
Siegl RMC, et al. Analysis of two endodontic techniques in primary molars with fistula. RGO. 2015;63(2):187-194.
Neves FG, et al. Cytotoxicity profile of endodontic irrigants: a systematic review. J Appl Oral Sci. 2018;26:e20170206.
Silva AR, et al. Comparative evaluation of chemical irrigants in intracanal bacterial reduction. Rev Odontol Bras. 2014;23(2):95-102.
Ferraz CCR. In vitro evaluation of chlorhexidine gel as an endodontic irrigant [thesis]. UNICAMP; 1999.
Gomes BP, Ferraz CC, Vianna ME, Berber VB, Teixeira FB, Souza-Filho FJ. In vitro antimicrobial activity of several concentrations of sodium hypochlorite and chlorhexidine gluconate in the elimination of Enterococcus faecalis. Int Endod J. 2001 Sep;34(6):424-8. doi: 10.1046/j.1365-2591.2001.00410.x.
PubMed 11556507Hulsmann M, Hahn W. Complications during root canal irrigation--literature review and case reports. Int Endod J. 2000 May;33(3):186-93. doi: 10.1046/j.1365-2591.2000.00303.x.
PubMed 11307434Zehnder M. Root canal irrigants. J Endod. 2006 May;32(5):389-98. doi: 10.1016/j.joen.2005.09.014.
PubMed 16631834Tanalp J, Gungor T. Apical extrusion of debris: a literature review of an inherent occurrence during root canal treatment. Int Endod J. 2014 Mar;47(3):211-21. doi: 10.1111/iej.12137. Epub 2013 May 25.
PubMed 23711187American Academy of Pediatric Dentistry. Behavior guidance for the pediatric dental patient. Chicago: AAPD; 2023
Klingberg G, Broberg AG. Dental fear/anxiety and dental behaviour management problems in children and adolescents: a review of prevalence and concomitant psychological factors. Int J Paediatr Dent. 2007 Nov;17(6):391-406. doi: 10.1111/j.1365-263X.2007.00872.x.
PubMed 17935593Lin PY, Huang SH, Chang HJ, Chi LY. The effect of rubber dam usage on the survival rate of teeth receiving initial root canal treatment: a nationwide population-based study. J Endod. 2014 Nov;40(11):1733-7. doi: 10.1016/j.joen.2014.07.007. Epub 2014 Aug 28.
PubMed 25175849American Association of Endodontists. Guide to Clinical Endodontics. 6th ed. Chicago: AAE; 2020.