Endodontic Treatment of Necrotic Primary Teeth With Guedes Pinto Paste: A Randomized Clinical Trial

February 27, 2018 updated by: Fausto Medeiros Mendes

Endodontic Treatment of Primary Teeth With Guedes Pinto Paste: A Randomized Clinical Trial

The maintenance of primary teeth until their exfoliation has been one of the main purposes of Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to conduct a randomized clinical trial with longitudinal follow-up of two years, double blind, to compare the degree of success of endodontic treatment in primary among the most used folder, Guedes Pinto paste, and one Calcium hydroxide and iodoform paste to control, Vitapex.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After approval by the ethics committee of the patients Faculty of Dentistry, University of São Paulo that having root canal filling of primary teeth will be invited to participate in the study. A clinical examination and prior radiographic diagnosis and also a quality of life questionnaire regarding oral health (- ECOHIS Early Childhood Oral Health Impact Scale) will be-held. The patient will be randomized to one of two groups and will be held endodontics by a blind handler. The patient will be accompanied with periods of one week, six months, 12 months and 24 months by a blinded evaluator. At the last visit of the review ECOHIS questionnaire will be reapplied to those responsible. The outcome will be the success or failure of endodontic treatments evaluated through permanent tooth in the arch on clinical and radiographic conditions of normality. The longevity of the treatments will be evaluated by estimating survival rates by Kaplan-Meier. The differences between the survival rates according to the type of proposed endodontic treatment will be analyzed using the log-rank test with a minimum significance level of 5%.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05850010
        • Carmela Bresolin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary teeth with pulp diagnosis and need endodontic treatment
  • Patients whose guardians consent to their participation in the survey
  • fistula or abscess
  • bone rarefaction or visual diagnosis
  • teeth in the remaining tooth structure and location of the injury rehabilitation permit
  • do not have internal or external resorption involving more than one third of the root length
  • have no bone loss in lateral root and disruption crypt and the presence of at least half of root

Exclusion Criteria:

  • health problems systemic
  • congenital facial deformities
  • facial tumors
  • syndromes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitapex
Endodontic treatment using Vitapex
Drug: Endodontic treatment using Vitapex
Endodontic treatment using Vitapex
Experimental: Guedes Pinto Paste
Endodontic treatment using Guedes Pinto
Drug: Endodontic treatment using Guedes Pinto
Endodontic treatment using Guedes Pinto paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success or failure of two endodontic treatments
Time Frame: two years
The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality. Clinical criteria for determining success are: absence of fistula, absence of painful symptoms and pathological absence of adequate mobility and gingival contour. Radiographically, the success criteria are: absence / reduction of periapical bone rarefaction in anterior and absence / bone rarefaction in the furcation area of later, maintaining the periradicular space, root resorption compatible with the eruptive phase and absence of pathological bone resorption. To evaluate the reduction of lesions or appearance of new lesions will be between the initial and follow-up radiographs. Radiographs will be scanned and the end of the bone rarefactions starting area and will be measured on a software image analysis.
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of the obturation obtained with the two root canal filling pastes
Time Frame: two years
The quality of the filling will be assessed by a blinded examiner according to two criteria. Through an index that ranks the shutter in satisfactory, questionable or unsatisfactory and through evaluation of digital radiographic images with the aid of a computational tool (Autodesk AutoCAD), where the visible areas of the root canal will be measured in previous radiographic examination and their measurements of the area of the root canal filling pastes filled with channels. The influence of the quality of the filling in the successful treatment will also be assessed.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fausto Medeiros Mendes

Investigators

  • Principal Investigator: Carmela Bresolin, PHD student, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 13, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FOUSP2408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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