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临床试验/NCT04200638
NCT04200638Unknown不适用

Effect of Three Mechanical Systems on Removal of Endotoxins From Necrotic Teeth With Apical Periodontitis After Two-visit RCT

Universidad Autonoma de Baja California2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年2月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Endotoxin test for both groups

研究概览

简要总结

The patients will be randomly assigned into two equal groups Group : OneShape Group: ProtaperNext

Endodontics procedure steps:

Patient will be anesthetized by using infiltration local anesthesia or nerve block according to the tooth location in mandibular or maxillary arch respectively.

All caries will be removed, then isolation using rubber dam, the crown and surrounding structures will be disinfected with 30% H2O2( hydrogen peroxide) for 30 seconds, followed by 2.5% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate.

2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will be used in conjunction with manual irrigation with sterile saline. Before entering the pulp chamber, the access cavity will be disinfected according to the protocol described above.

2- Root canal length will be determined, by preoperative radiograph then (S1) will be taken by introducing a sterile/apyrogenic paper point #15/ 20 (5paper points) into the full length of the canal and left there for 1 minute. Then, the sample will be placed in an apyrogenic glass and stored in -20°. Then canal length will be confirmed by apex locator.

3- Cleaning and shaping will be done using either One shape or Protaper next rotary instruments in crown down preparation technique with the use of in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instrument.

Lab procedures to identify microorganisms

详细描述

The patients will be randomly assigned into two equal groups Group : OneShape Group: ProtaperNext

Endodontics procedure steps:

Patient will be anesthetized by using infiltration local anesthesia or nerve block according to the tooth location in mandibular or maxillary arch respectively.

All caries will be removed, then isolation using rubber dam, the crown and surrounding structures will be disinfected with 30% H2O2( hydrogen peroxide) for 30 seconds, followed by 2.5% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate.

2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will be used in conjunction with manual irrigation with sterile saline. Before entering the pulp chamber, the access cavity will be disinfected according to the protocol described above.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participant, investigator and assessor.The trial design of this study will be a prospective, parallel.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The inclusion limitations were:
  • nonappearance of radiographic proof of apical inflammation.
  • irreversible pulpitis recognized by the positive reaction to thermal tests, and
  • persistent pre-operative pain due to the pulpal condition.
  • Patients must be in physical and emotional wellbeing.
  • Any drug used seven days' previous study.

排除标准

  • impossibility to obtain patient's consent,
  • patients younger than 18 years. Necrotic teeth and teeth with periapical injury, root resorption,
  • Patients rejecting to join the research, those with issues with single-visit RCT, those consuming a specific kind of medicine such as painkillers or NSAIDs, and participants with some unrestrained systemic ailment were excluded too.

结局指标

主要结局

Endotoxin test for both groups

时间窗: Endotoxin from fluid in ProTaper Next group

measure endotoxin concentrations in the root canals before and after chemomechanical procedures. 24 hrs after root canal treatment

次要结局

未报告次要终点

研究者

发起方
Universidad Autonoma de Baja California
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jorge Paredes Vieyra

Dr. Jorge Paredes Vieyra DDS, MsC, PhD

Universidad Autonoma de Baja California

研究点 (2)

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