In Vivo Assessment of Endodontics Procedures

Apical Periodontitis Clinical Trial

Official title:

In Vivo Assessment of Endodontics Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03243357
• Other study ID #: 68089517.2.0000.5152
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2017
• Est. completion date: November 3, 2020

Study information

• Verified date: May 2019
• Source: Federal University of Uberlandia
• Contact: Camilla C Gomes Moura, PhD
• Phone: +55 34 99924 9586
• Email: camillahistologia[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In view of the wide variety of mechanized endodontic instrumentation systems, the ideal would be that the choose of this system based on the anatomical characteristics of the canal and the biological precepts. In teeth with lesions, contaminated dentin should be removed. However, in many systems, the manufacturer's approach disregards the fact that in wider root canal, instruments used in the apical third small diameter (less than 0.40 mm) may not touch the walls at the final apical. Therefore, the establishment of the initial apical file (LAI), the first instrument that measures the resistance of the walls in working length, could be a criterion in the choice of which system to use, and how many files work within the root canals after LAI determination. However, there is a lack of studies that demonstrate that LAI determination affects the degree of cleaning achieved, as well as the impact that LAI-based instrumentation may have on microcracks formation, canal transportation, postoperative pain and quality of obturation.In this way, the investigators propose a study in vivo performed, in patients from 8 to 18 years of age, therefore in large root canals. The protocol recommended by the manufacturer will be compared by means of a prospective randomized clinical trial, with the addition of the XP Endo finisher and with the protocol based on the initial apical file evaluating postoperative pain, exacerbation between the sessions, the quality of the obturation and periapical radiolucency repair. Considering that currently performing endodontic treatments using mechanized instruments is taught in undergraduate courses throughout the country, studies of this nature help the execution of a endodontics more critical and effective.

Description:

Infected root canal treatments will be performed in two sessions with a TF Adaptive system (Protocol recommended by manufacturer (Group Control) vs. Protocol based on the initial apical file). The root canals will be completed after 14 days. Patients will record postoperative pain during the follow-up period (7 days) using a Visual analogue scale (VAS) and the change in periapical radiolucency will be assessed by periapical index (PAI) scores.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 3, 2020
• Est. primary completion date: March 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Participants who have in their mandibular or maxillary molar teeth apical periodontitis symptomatic or asymptomatic with apical radiolucence.

Exclusion Criteria:

• Patients with medical history compromises outcomes

• Atresic and root canals

• Root canals with curvature greater than 30 degrees

• Previously performed endodontics treatment.

Related Conditions & MeSH terms

• Apical Periodontitis
• Periapical Periodontitis
• Periodontitis

Intervention

Procedure:
• TF Adaptive (First Apical Binding File)
Procedure: TF Adaptive System NiTi (Nickel titanium) Endo File System (SybronEndo) The root canal instrumentation will be performed by the TF Adaptive features Adaptive Motion (Elements Motor). Procedure: Instrumentation based on protocol of First Apical Binding File The enlargement of the root canal will be performed with three files larger than the diameter of the previously established initial apical file.
• TF Adaptive (Control)
Procedure: TF Adaptive System NiTi (Nickel titanium)Endo File System The root canal instrumentation will be performed by the TF Adaptive features Adaptive Motion (Elements Motor). Procedure: Instrumentation based on manufacturer's protocol The enlargement of the root canal will be performed according to the manufacturer's directions.

Locations

Country	Name	City	State
Brazil	Federal University of Uberlandia	Uberlândia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level	A Visual Analogue Scale VAS scale will be used for the postoperative pain level. The patients will noted their postoperative pain level according to the VAS scale during the follow-up period.	7 days
Secondary	Periapical radiolucence Repair	The change will be observed in periapical radiolucence in X-ray at the 6 and 12-month follow-up visit to assess the treatment outcome The outcome measure will be the change in periapical radiolucency as assessed by periapical index (PAI) scores.	6 and 12 months