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OpenTrials
Completed

NCT Number: NCT03112291

Antimicrobial Pastes and Clinical Cases of Apexogenesis

The aim of this study was to perform a clinical and microbiological evaluation of teeth with incomplete apexogenesis and traumatic necrosis that were treated with a revascularization technique, evaluating the microbial reduction after the use a double antibiotic paste. Furthermore, the investigation also aims to identify the presence of Enterococcus faecalis and Porphyromomas gingivalis within the root canal system.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adriana Kelly de Sousa Santiago Barbosa

Fortaleza, Ceará, 60861635, Brazil

About this study

This investigation is a longitudinal prospective interventional study of a series of cases. Patients who sought treatment at the Faculty of Dentistry from June 2011 to September 2015 were selected. They should have one permanent tooth with traumatic necrosis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • They should have one permanent tooth with traumatic necrosis, which in turns should show color alteration, fistulae, periapical lesion, and/or internal or external root resorption, pain, or absence of pulp response to sensitivity tests at a clinical examination to be considered necrotic. Male and female patients who had not undergone antibiotic therapy 3 months before the treatment were included and clinical and radiographic examinations confirmed pulp necrosis.

Exclusion criteria

  • Patients who did use antibiotics
  • Patients who did loss of temporary coronary sealing between treatment sessions
  • Patients who give up the research

Treatment and study plan

Apexification

Procedure

Apexification forms a calcified barrier in teeth with open apexes and pulp necrosis. It is used to treat immature teeth, but it does not promote the continuity of root formation.

Other names: Pulp Revascularization

Primary outcomes

  1. Number of teeth with apex closed according to nolle stages.

    Time frame: 24 months

    The apical closure of the teeth was evaluated by radiography /computed tomography every 3 months according to the nolla stages, in which a tooth is considered to be a closed apex in stage 9 of nolla

Secondary outcomes

  1. Number of patients with clinically and radiographically observed fistulas

    Time frame: 6 months

    The occurrence of fistulas through clinical signs and symptoms was observed for a period of 6 months in which it was recorded in medical records

Sponsors and collaborators

Lead sponsor

Adriana Kelly de Sousa Santiago Barbosa

Other

Registry information

Official study title

Clinical and Microbiological Evaluation of a Series of Clinical Cases of Permanent Teeth With Incomplete Apexogenesis and Traumatic Necrosis, Treated With Double Antimicrobial Paste, Revascularization Procedures, and MTA

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Apr 13, 2017
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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