跳至主要内容
临床试验/NCT03780764
NCT03780764已完成不适用

Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using 2 Fixed Orthodontic Appliances

Jordan University of Science and Technology1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Pulpal blood flow changes by the use of Laser Doppler Flowmeter

研究概览

简要总结

  • Evaluate and compare initial changes in PBF between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage using 0.016" Nickle titanium (NiTi) and 0.016X0.022" NiTi archwires at different time intervals (20min, 24h, 72h, 1 week and 1 month) of initial arch wire placement.

详细描述

Objectives: to evaluate and compare the initial changes in pulpal blood flow (PBF) between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage.

Materials and Methods

A total of 22 patients (16 females and 6 males) aged 19± 2.53 years who presented with mild lower arch crowding were selected to participate in the study. A split mouth study design was applied for each patient. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients). PBF was measured for the lower right and left sides using Laser Doppler Flowmetry at different time intervals (20min, 24h, 72h, 1 week and 1 month) after the fitting of 2 alignment archwires; 0.016" NiTi and 0.016X0.022" NiTi. A repeated measures analysis of variance test and a Bonferroni post-hoc comparison test were applied to detect differences in PBF between the 2 groups.

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
None

入排标准

年龄范围
16 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Both male and female subjects
  • 6 or more years old
  • Class I skeletal malocclusion
  • mild lower arch crowding.

排除标准

  • Poor oral hygiene
  • Previous orthodontic treatment
  • Active periodontal disease
  • Missing teeth, deep carious teeth
  • Teeth with root resorption
  • Endodontically treated teeth
  • History of previous trauma
  • Restoration on measured teeth
  • Medical conditions affecting blood vessels and

研究组 & 干预措施

Conventional fixed appliance

Active Comparator

A pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022" Roth prescription brackets) on one side of lower arch.

干预措施: A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022" Roth prescription brackets (Other)

Self ligating fixed appliance

Experimental

Self-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets) on the other side.

干预措施: Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets (Other)

结局指标

主要结局

Pulpal blood flow changes by the use of Laser Doppler Flowmeter

时间窗: 20 minutes ,48 hours, 72 hours and 1 month

millimeter per second

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

Proffessor- Main investigator

Jordan University of Science and Technology

研究点 (1)

Loading locations...

相似试验