Non-instrumentation Root Canal Treatment of Primary Molars

NCT04942158 | Completed

• 1 other identifier: ENDODECIDE-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

Brief Summary

This randomized clinical trial intended to evaluate the efficacy of a technique of root canal treatment of deciduous molars with non-instrumentation of root canals and use of a paste containing antibiotics (chloramphenicol and tetracycline) and zinc oxide and eugenol (CTZ group). The hypothesis is that the efficacy of non-instrumentation treatment is non-inferior than the standard treatment involving manual instrumentation of root canals and filling with zinc oxide and eugenol paste (ZOE group) after 24 months of follow-up. Children will be randomly allocated to one of the two groups: CTZ group or ZOE group. In the CTZ group, after the location of root canals entrance, an initial irrigation will be conducted using 1% sodium hypochlorite. Then, CTZ paste will be placed in the pulp chamber floor, over the root canal entrances. The instrumentation of the root canals will not be performed for children allocated to this group. For the ZOE group, manual instrumentation with endodontic K files will be performed, aided by irrigation with 1% sodium hypochlorite. After the end of the instrumentation, root canals will be filled with ZOE paste. All teeth will be restored with bulk-fil resin composite. Children will be followed-up for 6, 12, 18 and 24 months after the treatment. The primary endpoint will be the success of endodontic treatment evaluated by clinical and radiographic methods after 24 months. Based on a non-inferiority limit of 15% in the success rate, an anticipated sample size of 218 (109 per group) was estimated, divided among the centers. This sample size was further corrected two times (due to slower-than-anticipated recruitment, and due to the drop of a center participant of the study), reaching a required minimum sample size of 182 participants (91 participants per group). Other secondary endpoints will be clinical time spent with the treatments, children's behavior during the treatment, discomfort immediately after the end of the treatment reported by the children, post-operative pain, improvement in the negative impact of Oral Health-Related Quality of Life, costs and cost-efficacy.

Conditions

Dental Pulp Diseases; Dental Pulp Necrosis

Keywords

Endodontic treatment; Primary teeth; Non-instrumentation technique; CTZ paste; Pulpectomy

Outcome Measures

Primary Outcomes (1)

• Success of endodontic treatment

  The success of the endodontic treatment is a dichotomous variable that will be defined through clinical and radiographic evaluation after 24 months. Clinical criteria for determining success will be the absence of fistula, edema, pain, pathological mobility, presence of periodontal health or physiological primary molar exfoliation. Radiographic signs of success will be: absence of bone rarefaction, or in the presence of previous endodontic lesion, reduction or non-evolution of this lesion, compatible root resorption with the eruptive phase, absence of pathological root resorption and presence of restorative material isolating the filling paste from the oral cavity. In the presence of any signs of failure in any period of follow-up, the treatment will be considered unsuccessful. The main comparisons between the groups will be done considering the frequency rate of success treatment 24 months after the treatment, when absence of failure was detected in all follow-ups.

  24 months

Secondary Outcomes (10)

• Clinical time

  During the treatment procedure

• Children's behavior during the treatment

  During the treatment procedure

• Children's discomfort immediately after the intervention

  Immediately after intervention

• Postoperative pain, edema or fistula

  Two days after the end of the intervention

• Short-term impact of the treatment on Oral Health-Related Quality of Life reported by the children

  One week after the end of the intervention

Study Arms (2)

CTZ group

EXPERIMENTAL

Non-instrumentation endodontic treatment and use of a paste containing two antibiotics (chloramphenicol and tetracycline) and zinc oxide and eugenol (CTZ paste)

Procedure: Non-instrumentation technique with use of CTZ paste

ZOE group

ACTIVE COMPARATOR

Endodontic treatment with instrumentation and filling with Zinc Oxide and Eugenol paste (ZOE paste)

Procedure: Instrumentation technique and filling with Zinc Oxide and Eugenol paste

Interventions

Non-instrumentation technique with use of CTZ paste PROCEDURE

After local anesthesia and rubber dam isolation, the pulp chamber will be accessed. After the location of root canals entrance, an initial irrigation will be conducted using 1% sodium hypochlorite. Then, a paste containing two antibiotics (chloramphenicol and tetracycline) and zinc oxide and eugenol (CTZ paste) will be placed in the pulp chamber floor, into the root canal entrances. Then, a layer of glass ionomer cement will be placed, and the teeth will be restored with bulk-fil resin composite.

CTZ group

Instrumentation technique and filling with Zinc Oxide and Eugenol paste PROCEDURE

After anesthesia and rubber dam isolation, pulp chamber will be accessed with burs, and the root canals entrance will be prepared using a Gates Glidden bur. The root canal length determination will be done subtracting 1 mm from the radiographic measurements performed on the different roots. The instrumentation will be performed with 21mm stainless steel endodontic hand K-files, with International Organization for Standardization (ISO) tip ranging from #08 to #35. Irrigation will be performed using 1% sodium hypochlorite. After the last file, a final irrigation will be conducted with ethylenediaminetetraacetic acid and tegentol (EDTA-T) and 0.9% sodium chloride solution, and the root canals will be dried with paper points. Then, the root canals will be filled with a Zinc Oxide and Eugenol paste (ZOE paste), inserted into the root canals with a lentulo spiral. A layer of glass ionomer cement will be placed, and the teeth will be restored with bulk-fil resin composite.

ZOE group

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children who look for dental treatment
• Children with at least one primary molar with clinical and/or radiographic signs of pulpal involvement
• Formal consent of the children's parents or legal guardians agreeing with the participation of the children
• Write or verbal assent of the children in participating of the study

You may not qualify if:

• Children with special needs
• Children with report of allergy to the medications used in the pastes

Sponsors & Collaborators

• University of Sao Paulo: lead
• Santa Catarina Federal University: collaborator
• Rio de Janeiro State University: collaborator
• Iguaçu University: collaborator

Study Sites (4)

Iguaçu University

Itaperuna, Rio de Janeiro, 28300-000, Brazil

Location

Rio de Janeiro State University

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

Location

Santa Catarina Federal University

Florianópolis, Santa Catarina, 88040-900, Brazil

Location

School of Dentistry, University of Sao Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

Related Publications (5)

• Coll JA, Dhar V, Vargas K, Chen CY, Crystal YO, AlShamali S, Marghalani AA. Use of Non-Vital Pulp Therapies in Primary Teeth. Pediatr Dent. 2020 Sep 15;42(5):337-349.

  PMID: 33087217 BACKGROUND

• Pezzini Soares J, Cardoso M, Bolan M. Demystifying behaviour and dental anxiety in schoolchildren during endodontic treatment for primary teeth-controlled clinical trial. Int J Paediatr Dent. 2019 May;29(3):249-256. doi: 10.1111/ipd.12468. Epub 2019 Feb 1.

  PMID: 30656782 BACKGROUND

• Duarte ML, Pires PM, Ferreira DM, Pintor AVB, de Almeida Neves A, Maia LC, Primo LG. Is there evidence for the use of lesion sterilization and tissue repair therapy in the endodontic treatment of primary teeth? A systematic review and meta-analyses. Clin Oral Investig. 2020 Sep;24(9):2959-2972. doi: 10.1007/s00784-020-03415-0. Epub 2020 Jul 14.

  PMID: 32666347 BACKGROUND

• Cappiello J. Pulp treatment in primary incisors [Spanish]. Rev Asoc Odontol Argent. 1964; 52(4): 139-145.

  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: 27472562 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases; Dental Pulp Necrosis

Interventions

Zinc Oxide

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Fausto M Mendes, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Multi-center, open label, non-inferiority randomized controlled trial

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 28, 2021
• Study Start: October 4, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the acceptance of the manuscript containing the main analysis of the primary outcome (about 3 years after the beginning of the study).
• Access Criteria: The access will be allowed for any researcher. Utilization of the data should be done with adequate citation of the original source.

Locations

BR (4)