In Vivo Assessment of Endodontics Procedures
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2017
CompletedFirst Posted
Study publicly available on registry
August 9, 2017
CompletedStudy Start
First participant enrolled
November 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2020
CompletedMay 21, 2019
May 1, 2019
2.3 years
July 26, 2017
May 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Periapical radiolucence Repair
6 and 12 months
Study Arms (2)
TF Adaptive (First Apical Binding File)
EXPERIMENTALEndodontic 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.
TF Adaptive (Control)
OTHERIn 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Participants who have in their mandibular or maxillary molar teeth apical periodontitis symptomatic or asymptomatic with apical radiolucence.
You may not qualify if:
- Patients with medical history compromises outcomes
- Atresic and root canals
- Root canals with curvature greater than 30 degrees
- Previously performed endodontics treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Uberlandia
Uberlândia, Minas Gerais, 38405-900, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Camilla C Gomes Moura, PhD
Federal University of Uberlandia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct Professor of Endodontics of Faculty of Dentistry of Federal University of Uberlandia
Study Record Dates
First Submitted
July 26, 2017
First Posted
August 9, 2017
Study Start
November 22, 2017
Primary Completion
March 7, 2020
Study Completion
November 3, 2020
Last Updated
May 21, 2019
Record last verified: 2019-05