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Antimicrobial Pastes and Clinical Cases of Apexogenesis

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ClinicalTrials.gov Identifier: NCT03112291
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Adriana Kelly de Sousa Santiago Barbosa, Universidade Federal do Ceara

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Apexification Root Canal Therapy Dental Trauma Procedure: Apexification Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This investigation is a longitudinal prospective interventional study of a series of cases
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 25, 2011
Actual Primary Completion Date : June 10, 2015
Actual Study Completion Date : October 8, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: permanent teeth apexification
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. This study analyzed the clinical and microbiological results of the endodontic treatment performed on permanent teeth with necrosis caused by traumatic injury and treated using revascularization technique, double antibiotic paste, intra-canal medication, and an MTA cervical plug.
Procedure: Apexification
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 Name: Pulp Revascularization




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03112291


Locations
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Brazil
Adriana Kelly de Sousa Santiago Barbosa
Fortaleza, Ceará, Brazil, 60861635
Sponsors and Collaborators
Adriana Kelly de Sousa Santiago Barbosa
Investigators
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Study Director: José Jeová S Moreira Neto, Dr Universidade Federal do Ceará

Publications of Results:
Other Publications:
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Responsible Party: Adriana Kelly de Sousa Santiago Barbosa, PhD, Universidade Federal do Ceara
ClinicalTrials.gov Identifier: NCT03112291     History of Changes
Other Study ID Numbers: Estudo Clinico - Apicificação
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Adriana Kelly de Sousa Santiago Barbosa, Universidade Federal do Ceara:
anti-microbial agents
apexification
dental pulp
endodontics
root canal therapy
dental trauma

Additional relevant MeSH terms:
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Anti-Infective Agents
Anti-Bacterial Agents