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

NCT03650036 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2022-03-16

No results posted yet for this study

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

Interventions

DRUG

Pulp Therapy CTZ Paste

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.

DRUG

Pulp Therapy ZOE Paste

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.

Sponsors & Collaborators

  • Federal University of Piaui

    lead OTHER

Principal Investigators

  • Lúcia Moura, Professor · Federal University of Piaui

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2019-05-21
Completion
2022-03-04

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03650036 on ClinicalTrials.gov