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Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste

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ClinicalTrials.gov Identifier: NCT02887456
Recruitment Status : Completed
First Posted : September 2, 2016
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Fausto Medeiros Mendes, University of Sao Paulo

Brief Summary:
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 is to evaluate the performance of endodontic treatment in primary teeth using MTA paste, comparing to Vitapex.

Condition or disease Intervention/treatment Phase
Teeth, Endodontically-Treated Drug: Endodontic treatment using Vitapex Drug: Endodontic treatment using MTA paste Phase 2

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 will be-held. The patient will be randomized to one of two groups and will be made the endodontics by a dentist. The patient will be accompanied with periods of one week, one month and three months by a blinded evaluator. 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%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste - Protocol of a Phase 2 Randomized Clinical Trial
Study Start Date : September 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Active Comparator: Vitapex
Endodontic treatment using Vitapex
Drug: Endodontic treatment using Vitapex
Endodontic treatment using Vitapex

Experimental: MTA paste
Endodontic treatment using MTA paste
Drug: Endodontic treatment using MTA paste
Endodontic treatment using MTA paste




Primary Outcome Measures :
  1. Success or failure of endodontic treatments [ Time Frame: 3 months ]
    The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality, able to maintain or restore the health of periodical tissues after the treatment. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887456


Locations
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Brazil
Carmela Bresolin
São Paulo, Brazil, 05850010
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Carmela Bresolin Faculdade de Odontologia da USP

Publications of Results:
Other Publications:
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Responsible Party: Fausto Medeiros Mendes, Associated Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02887456     History of Changes
Other Study ID Numbers: EndoMTA
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Tooth, Nonvital
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases