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临床试验/NCT03243357
NCT03243357Unknown不适用

In Vivo Assessment of Endodontics Procedures

Federal University of Uberlandia2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年11月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Pain level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Patients with medical history compromises outcomes
  • Atresic and root canals
  • Root canals with curvature greater than 30 degrees
  • Previously performed endodontics treatment.

研究组 & 干预措施

TF Adaptive (First Apical Binding File)

Experimental

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.

干预措施: TF Adaptive (First Apical Binding File) (Procedure)

TF Adaptive (Control)

Other

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.

干预措施: TF Adaptive (Control) (Procedure)

结局指标

主要结局

Pain level

时间窗: 7 days

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.

次要结局

  • Periapical radiolucence Repair(6 and 12 months)

研究者

发起方
Federal University of Uberlandia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Camilla Christian Gomes Moura

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

Federal University of Uberlandia

研究点 (2)

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