Non-instrumentation Root Canal Treatment of Primary Molars

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

Interventions

PROCEDURE

Non-instrumentation technique with use of CTZ paste

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.

PROCEDURE

Instrumentation technique and filling with Zinc Oxide and Eugenol paste

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.

Sponsors & Collaborators

• Santa Catarina Federal University

  collaborator OTHER

• Rio de Janeiro State University

  collaborator OTHER

• Iguaçu University

  collaborator UNKNOWN

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Fausto M Mendes, PhD · University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-04

Primary Completion

2025-04-30

Completion

2025-04-30

Countries

• Brazil

Study Locations