Root Canal Treatment in Primary Molars With Necrotic Pulp Using Two Different Pulp Therapies

NCT03650036 | Completed Phase 2

• 1 other identifier: Ppgo2018
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This is a controlled, randomized, double-blind clinical study (researcher and research participant does not know which group they belong to), with the objective of evaluating clinical and radiographic performances of primary molar canal treatments with necrotic pulps using two obturator pulps. The CTZ paste (composed of chloramphenicol, tetracycline, zinc oxide and eugenol) and the ZOE paste (composed of zinc oxide and eugenol). The CTZ paste represents an alternative treatment that makes possible to treat canals of primary molars in a simplified way, without instrumentation of root canals. Studies with the CTZ pulp have demonstrated satisfactory clinical and radiographic results in addition to biocompatibility and good antimicrobial action. The zinc oxide and eugenol paste has been studied, presents good clinical and radiographic results, it is indicated by the American Academy of Paediatric Dentistry and requires mechanical chemical preparation of the root canals. Children of both sexes, frequenters of the paediatric dentistry clinic of the Federal University of Piaui who present lower deciduous molars with clinical history and / or radiographic evidences of pulp necrosis will participate in the study. The hypothesis of the study is that both pastes present similar clinical and radiographic results.

Conditions

Dental Pulp Necrosis

Keywords

Primary teeth; Dental Pulp Necrosis; Root Canal Obturation

Outcome Measures

Primary Outcomes (2)

• Infection control of deciduous molars with necrotic pulp by clinical examination

  The methods used to evaluate the primary outcome involved clinical evaluation. Clinical evaluation will be carried out by two Pediatric Dentists who did not participate in the project and blind to which group the teeth belong to and if there is a discrepancy in evaluations, a third evaluator will be called. When there are absences of reports of pain, abscess and mobility incompatible with chronological age at the times evaluated will be considered clinical success.

  up to 36 months

• Infection control of deciduous molars with necrotic pulp by Radiographic examination

  The methods used to evaluate the primary outcome involved radiographic evaluation. Radiographic evaluations will be performed by two Dental Radiologists, who did not participate in the study. Radiographic success will be evidenced by the regression or absence of radiolucency in the interradicular region and absence of pathological root resorptions.

  up to 36 months

Secondary Outcomes (1)

• 1. The improvement in the Quality of life of children after pulp therapy using a questionnaire

  Three months after pulp therapy.

Study Arms (2)

Group 1

EXPERIMENTAL

In group 1, Pulp Therapy will be done with the CTZ paste (composed of 62.5 mg of chloramphenicol, 62.5 mg of tetracycline, 125 mg of zinc oxide) will be manipulate with 0.1ml of eugenol in a sterile glass plate with flexible metal spatula at the time of use and will be taken at the tip of a number 5 exploratory probe and dispensed at the entrances of the root canals where it will be accommodated with light pressure of sterile cotton balls. The CTZ paste will be protected with a thin layer of gutta-percha, previously heated in an alcohol lamp and placed in a thin layer on the CTZ pulp. The gutta-percha blade will be condensed with medium size amalgam presser and has the objective of physically isolating the CTZ paste from the restorative material.

Drug: Pulp Therapy CTZ Paste

Group 2

EXPERIMENTAL

In Group 2, Pulp Therapy will be done with ZOE paste. The mechanical preparation of the root canals with 2% chlorhexidine solution and first-series K files will be performed. The instrumentation limit shall be 1 mm short of the radiographic apex. After finishing the chemical-mechanical preparation, drying of the root canals with sterile absorbent paper cones and ZOE paste insertion with K files will be performed. The zinc oxide of the ZOE paste will be supplied in 250mg capsules and handled with 0.1ml eugenol in a sterile glass plate with metal spatula at the time of use. The protection of the ZOE paste will follow the same sequence as the CTZ paste.

Drug: Pulp Therapy ZOE Paste

Interventions

Pulp Therapy CTZ Paste DRUG

CTZ paste is composed of 62.5 mg of chloramphenicol, 62.5 mg of tetracycline and 125 mg of zinc oxide and manipulated with 0.1ml of eugenol in a sterile glass plate with flexible metal spatula at the time of use.

Also known as: Endodontic Treatment

Group 1

Pulp Therapy ZOE Paste DRUG

The zinc oxide of the ZOE paste will be supplied in 250mg capsules and handled with 0.1ml eugenol in a sterile glass plate with metal spatula at the time of use.

Also known as: Endodontic Treatment

Group 2

Eligibility Criteria

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

You may qualify if:

• Lower primary molars with clinical and / or radiographic history of pulp necrosis.
• Crown with sufficient dental structure to be restored with stainless steel crown.
• Rhizolysis equal to or less than 1/3.

You may not qualify if:

• Teeth that present calcium metamorphosis.
• Pathological root resorption.
• Coronary destruction that makes it impossible for the tooth to be restored.
• You have been using antibiotics for the last three months.

Sponsors & Collaborators

• Federal University of Piaui: lead

Study Sites (1)

Federal University of Piaui

Teresina, Piauí, 64.049-550, Brazil

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Endodontics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Lúcia Moura, Professor

  Federal University of Piaui

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The clinical evaluations will be performed by two Paediatric Dentists who will not participate in the clinical part and will not know which group the teeth belong to. Participants also will not know in which group they will be allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor at Federal University of Piaui Dentistry course

Model Details: The patients will be allocated into two groups and will remain in the group until the end of the experiment.

Study Record Dates

• First Submitted: August 18, 2018
• First Posted: August 28, 2018
• Study Start: June 4, 2018
• Primary Completion: May 21, 2019
• Study Completion: March 4, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)