drugset / Trial / NCT03650036

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

NCT03650036

Phase 2 Completed 86 enrolled Federal University of Piaui
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Tetracycline Unknown 62.5 mg
Subject Zinc Oxide Unknown 125 mg
Subject Zinc Oxide Unknown 250 mg
Subject chloramphenicol Small molecule 62.5 mg
Subject eugenol Small molecule 0.1 ml

Indications