Antimicrobial Pastes and Clinical Cases of Apexogenesis

NCT03112291 | Completed DMC

• 1 other identifier: Estudo Clinico - Apicificação
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Apexification; Root Canal Therapy; Dental Trauma

Keywords

anti-microbial agents; apexification; dental pulp; endodontics; root canal therapy; dental trauma

Outcome Measures

Primary Outcomes (1)

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

  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

  24 months

Secondary Outcomes (1)

• Number of patients with clinically and radiographically observed fistulas

  6 months

Study Arms (1)

permanent teeth apexification

EXPERIMENTAL

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

Interventions

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.

Also known as: Pulp Revascularization

permanent teeth apexification

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Adriana Kelly de Sousa Santiago Barbosa: lead

Study Sites (1)

Adriana Kelly de Sousa Santiago Barbosa

Fortaleza, Ceará, 60861635, Brazil

Location

Related Publications (3)

• Pace R, Giuliani V, Nieri M, Di Nasso L, Pagavino G. Mineral trioxide aggregate as apical plug in teeth with necrotic pulp and immature apices: a 10-year case series. J Endod. 2014 Aug;40(8):1250-4. doi: 10.1016/j.joen.2013.12.007. Epub 2014 Apr 3.

  PMID: 25069943 BACKGROUND

• Nagata JY, Gomes BP, Rocha Lima TF, Murakami LS, de Faria DE, Campos GR, de Souza-Filho FJ, Soares Ade J. Traumatized immature teeth treated with 2 protocols of pulp revascularization. J Endod. 2014 May;40(5):606-12. doi: 10.1016/j.joen.2014.01.032. Epub 2014 Mar 6.

  PMID: 24767551 RESULT

• Trope M. Treatment of the immature tooth with a non-vital pulp and apical periodontitis. Dent Clin North Am. 2010 Apr;54(2):313-24. doi: 10.1016/j.cden.2009.12.006.

  PMID: 20433980 RESULT

MeSH Terms

Interventions

Apexification

Intervention Hierarchy (Ancestors)

Root Canal Therapy; Endodontics; Dentistry

Study Officials

• José Jeová S Moreira Neto, Dr

  Universidade Federal do Ceará

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: This investigation is a longitudinal prospective interventional study of a series of cases

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 13, 2017
• Study Start: November 25, 2011
• Primary Completion: June 10, 2015
• Study Completion: October 8, 2016
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)