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In Vivo Assessment of Endodontics Procedures

Primary Purpose

Apical Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TF Adaptive (First Apical Binding File)
TF Adaptive (Control)
Sponsored by
Federal University of Uberlandia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis focused on measuring Endodontics, molars, instrumentation, obturation, anatomy

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University of UberlandiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

TF Adaptive (First Apical Binding File)

TF Adaptive (Control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 26, 2017
Last Updated
May 18, 2019
Sponsor
Federal University of Uberlandia
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1. Study Identification

Unique Protocol Identification Number
NCT03243357
Brief Title
In Vivo Assessment of Endodontics Procedures
Official Title
In Vivo Assessment of Endodontics Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 22, 2017 (Actual)
Primary Completion Date
March 7, 2020 (Anticipated)
Study Completion Date
November 3, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Uberlandia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis
Keywords
Endodontics, molars, instrumentation, obturation, anatomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TF Adaptive (First Apical Binding File)
Arm Type
Experimental
Arm Description
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.
Arm Title
TF Adaptive (Control)
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
TF Adaptive (First Apical Binding File)
Intervention Description
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
Intervention Name(s)
TF Adaptive (Control)
Other Intervention Name(s)
TF Adaptive (Manufacturer's protocol)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain level
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Periapical radiolucence Repair
Description
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.
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla C Gomes Moura, PhD
Phone
+55 34 99924 9586
Email
camillahistologia@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Thaís C Cunha, Ms
Phone
+55 34 99172 1990
Email
christina.thais@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camilla C Gomes Moura, PhD
Organizational Affiliation
Federal University of Uberlandia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Uberlandia
City
Uberlândia
State/Province
Minas Gerais
ZIP/Postal Code
38405-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla C Gomes Moura, PhD
Phone
+55 34 99924 9586
Email
camillahistologia@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Thaís C Cunha, Ms
Phone
+55 34 99172 1990
Email
christina.thais@gmail.com

12. IPD Sharing Statement

Learn more about this trial

In Vivo Assessment of Endodontics Procedures

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