In Vivo Assessment of Endodontics Procedures

NCT ID: NCT03243357

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-22
• Study Completion Date: 2020-11-03

Brief 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.

Detailed 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.

Conditions

Apical Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TF Adaptive (First Apical Binding File)

Endodontic treatment(teeth with periapical periodontitis\&radiolucence).Local anesthesia (4%Articaine with1:100,000 epinephrine),isolation with rubber dam\&standard access cavity preparation.Using 2.5 %sodium hypochlorite,canal negotiation,glide path,coronal flaring with Sx(ProTaper),determining working length\&first apical binding file.Intervention: Root canal instrumentation:TF Adaptive system with enlargement of the root canal performed with up to 3 files larger than the diameter of the initial apical file. Irrigation2.5%NaOCl\&EDTA (Ethylenediaminetetraacetic acid)under activation with ultrasound. Irrigation with saline solution and placement of medication based on calcium hydroxide. After 14 days, obturation: gutta-percha\&epoxy resin sealer.

Group Type: EXPERIMENTAL

TF Adaptive (First Apical Binding File)

Intervention Type: PROCEDURE

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)

In the control group,endodontic treatment (teeth with periapical periodontitis\&radiolucence). Local anesthesia(4% Articaine with 1:100,000 epinephrine), isolation with rubber dam\&standard access cavity preparation. Using 2.5 % sodium hypochlorite, canal negotiation, determining working length\&glide path. Root canal instrumentation:TF Adaptive system according to the protocol recommended by the manufacturer.Irrigation 2.5% NaOCl \& EDTA(Ethylenediaminetetraacetic acid)under activation with ultrasound. Irrigation with saline solution and placement of medication based on calcium hydroxide. After 14 days, the canals will be obturated with gutta-percha and epoxy resin sealer.

Group Type: OTHER

TF Adaptive (Control)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

TF Adaptive (Manufacturer's protocol)

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Uberlandia

OTHER

Sponsor Role: lead

Responsible Party

Camilla Christian Gomes Moura

Adjunct Professor of Endodontics of Faculty of Dentistry of Federal University of Uberlandia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Camilla C Gomes Moura, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

Federal University of Uberlandia

Uberlândia, Minas Gerais, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Camilla C Gomes Moura, PhD

Role: CONTACT

camillahistologia@yahoo.com.br

+55 34 99924 9586

Thaís C Cunha, Ms

Role: CONTACT

christina.thais@gmail.com

+55 34 99172 1990

Facility Contacts

Camilla C Gomes Moura, PhD

Role: primary

camillahistologia@yahoo.com.br

+55 34 99924 9586

Thaís C Cunha, Ms

Role: backup

christina.thais@gmail.com

+55 34 99172 1990

Other Identifiers

68089517.2.0000.5152

Identifier Type: -

Identifier Source: org_study_id