Antimicrobial Pastes and Clinical Cases of Apexogenesis

Not Applicable

Completed

• Conditions: Root Canal Therapy; Apexification; Dental Trauma

• Registration Number: NCT03112291
• Lead Sponsor: Adriana Kelly de Sousa Santiago Barbosa

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.

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.

Study Timeline

• Study Start: 2011-11-25
• Primary Completion: 2015-06-10
• Study Completion: 2016-10-08
• Status Verified: 2017-04
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-09
• Last Update Submitted: 2017-04-09
• Study First Posted: 2017-04-13
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of teeth with apex closed according to nolle stages.	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

Name	Time	Method
Number of patients with clinically and radiographically observed fistulas	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

Trial Locations

Locations (1)

Adriana Kelly de Sousa Santiago Barbosa; 🇧🇷 Fortaleza, Ceará, Brazil