Clinical trial NCT03112291: Antimicrobial Pastes and Clinical Cases of Apexogenesis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apexification
Root Canal Therapy
Dental Trauma
Keywords: anti-microbial agents
apexification
dental pulp
endodontics
root canal therapy
dental trauma
Lead sponsor: Universidade Federal do Ceara
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This investigation is a longitudinal prospective interventional study of a series of cases
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of teeth with apex closed according to nolle stages.
timeFrame: 24 months
Secondary outcomes:
measure: Number of patients with clinically and radiographically observed fistulas
timeFrame: 6 months
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Adriana Kelly de Sousa Santiago Barbosa
state: Ceará
Study officials:
affiliation: Universidade Federal do Ceará
name: José Jeová S Moreira Neto, Dr
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.