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Clinical Applicability of PBSCIMMO as a Single Material in Endodontic Obturations

NCT03514264 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-06-06

No results posted yet for this study

Summary

A randomized, interventional, prospective, unicentric clinical study, 86 patients will be submitted to endodontic treatment of necrotic teeth. 43 patients will complete treatment with obturation with AHPlus cement and Gutta-Percha cones (group A) and 43 patients will complete treatment with PBS® CIMMO cement (single material) (group B). The primary outcome will be the repair of the periradicular lesion demonstrated by integrity of the hard blade throughout the perimeter of the root identified by Tomography Cone Beam, performed after 6 months of treatment. The secondary endpoint will be the absence of fistula after 6 months of treatment identified by clinical examination.

Conditions

  • Root Canal Therapy

Interventions

PROCEDURE

Gutta Percha and AHPLUS cement (group A)

First intervention: endodontic instrumentation and introduction of intact medication that will remain inside the tooth for 4 weeks. Second intervention: removal of intracanal medication and canal filling with cement AHPLUS and guttapercha

PROCEDURE

PBS CIMMO cement (group B)

Single intervention: endodontic instrumentation and obturation with cement PBS CIMMO

Sponsors & Collaborators

  • Universidade do Vale do Sapucai

    lead OTHER

Principal Investigators

  • Rubia Boczar · Univás-Universidade do Vale do Sapucaí- Pouso Alegre Minas Geraes

  • Taylor b Schnaider, MD,PhD · Universidade Vale do Sapucaí

  • Daniela F Veiga, MD,PhD · Universidade Vale do Sapucaí

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-09
Primary Completion
2018-06-05
Completion
2019-02-26

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 NCT03514264 on ClinicalTrials.gov