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临床试验/NCT04378205
NCT04378205已完成不适用

Pulpal Blood Flow Changes Related to Using SuperElastic 0.018-inch Nickel Titanium as the First Orthodontic Alignment Archwire: A Prospective Clinical Trial

Jordan University of Science and Technology1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Pulpal blood flow changes

研究概览

简要总结

to record pulpal blood flow (PBF) changes associated with using 0.018-inch Nickel Titanium (NiTi) as the first alignment archwire during fixed orthodontic treatment.

详细描述

Forty healthy patients with lower arch mild crowding with less than 2mm contact point displacement at any teeth were included. A split mouth study design was applied. Where each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch.

Patients were assigned into one of 2 groups based on archwire sizes used. Group (1); 0.014-inch and 0.018-inch NiTi and Group (2); 0.016-inch and 0.018-inch NiTi. A Laser Doppler Flowmeter was used to measure PBF at different time intervals (T0-T5).

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)

盲法说明

Psarticipants did not know which size is allocated/side.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-25 years
  • Class I skeletal malocclusion
  • Mild lower arches crowding.
  • Contact point displacement less than 2 mm.
  • No previous orthodontic treatment

排除标准

  • Missing teeth
  • Poor oral hygiene
  • deep carious teeth
  • history of previous trauma
  • any medical conditions affecting blood vessels

结局指标

主要结局

Pulpal blood flow changes

时间窗: up to 4 weeks

Measurements were taken by the use of Laser Doppler Flowmeter mm/s

次要结局

未报告次要终点

研究者

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

Elham Abu Alhaija

Professor

Jordan University of Science and Technology

研究点 (1)

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