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临床试验/NCT04767399
NCT04767399Unknown不适用

Comparison of Postoperative Pain After Root Canal Preparation, in Single and Multiple Visits, With Reciprocating and Rotary Single-File Systems: A Randomized Clinical Trial.

Riyadh Elm University2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年9月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
2
主要终点
Visual analogue scale

研究概览

简要总结

Comparison of Postoperative Pain after Root Canal preparation, in Single and Multiple Visits, with Reciprocating and Rotary Single-File Systems: A Randomized Clinical Trial.

Aim:1. Compare between the postoperative pain after root canal preparation, in single and multiple visits.

  1. To assess the influence of reciprocating and rotary single-file systems instrumentation on post-operative pain.

详细描述

Subjects allocation and randomization method:

  • All diagnoses and treatment procedures will be performed by a single operator in one visit or multiple visits to eliminate or minimize individual variability in the treatment between clinicians.
  • Total of 160 patients, as per the inclusion criteria will be intervened. This will be divided into two groups as follows:
  1. Group A (n=80) single visit.
  2. Group B (n=80) multiple visits.
  • Group A and B will be subdivided into two groups (each group=40) based on the motion of the files to be used either Reciprocation EOF (Edge one Fire file) or Rotational motion PN (ProTaper Next files). Each subgroup will be divided based on either the tooth is vital or non-vital (each subgroup=20) as shown in study design (Figure 1).

(Figure 1)

  • A pulpal and periapical diagnoses will be done for each tooth on taking careful history, clinical and radiographic examination based on the American Association of Endodontists (AAE 2008) diagnostic guidelines.
  • The treatments in groups A or B by ProTaper Next or Edge one Fire will be randomized with sequentially numbered opaque sealed envelopes (SNOSE) with 40 patients in PN group and 40 patients in EOF group with allocation sequence and assigning to intervention which will be done by blinded second investigator at the time of cleaning and shaping, concealed from operator to reduce bias.

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)

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • a. All permanent teeth diagnosed with vital or non-vital pulps and need nonsurgical root canal treatment.
  • b. Symptomatic, Asymptomatic maxillary and mandibular teeth with apical radiolucency c. All males and females with age between 19 to 60 years.

排除标准

  • a. Teeth with Previously treated b. Teeth need surgical treatment. c. Primary teeth. d. Patients with sinus tract, periapical abscess and who had previously medications.

结局指标

主要结局

Visual analogue scale

时间窗: 24 months

appointment treatment at 24 month \[ Time Frame: 12, 24, 48, h \] where 0 out of 10 scale will indicates no pain and 10 out of 10 indicates worse pain

次要结局

  • Verbal analogue scale(24 moths)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yahia Abdullah Alyami

postgraduate resident

Riyadh Elm University

研究点 (2)

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