Antimicrobial Pastes and Clinical Cases of Apexogenesis

Dental Trauma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112291
• Other study ID #: Estudo Clinico - Apicificação
• Status: Completed
• Phase: N/A
• First received: April 4, 2017
• Last updated: April 9, 2017
• Start date: November 25, 2011
• Est. completion date: October 8, 2016

Study information

• Verified date: April 2017
• Source: Universidade Federal do Ceara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 8, 2016
• Est. primary completion date: June 10, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Apexification
• Dental Trauma
• Root Canal Therapy

Intervention

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.

Locations

Country	Name	City	State
Brazil	Adriana Kelly de Sousa Santiago Barbosa	Fortaleza	Ceará

Sponsors (1)

Lead Sponsor	Collaborator
Adriana Kelly de Sousa Santiago Barbosa

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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 — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with clinically and radiographically observed fistulas	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	6 months