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临床试验/NCT03772795
NCT03772795已完成不适用

Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using Clear Aligners

Jordan University of Science and Technology0 个研究点目标入组 45 人开始时间: 2017年1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
45
主要终点
Pulpal blood flow changes by the use of Laser Doppler Flowmeter (Moor lab, Moor instruments, UK) with a wavelength of 780 nm and a dental probe MP 13 (Moor instruments, UK; 2 fibers, 0.25 mm diameter, centers 0.5 mm spaced apart).

研究概览

简要总结

The aims of this study were to: -

  • Evaluate PBF in upper and lower teeth during orthodontic alignment using fixed appliances (0.014" super elastic NiTi arch wire) at different time intervals (20min, 48h, 72h and 1 month) of initial arch wire placement.
  • Evaluate the PBF in upper and lower teeth during orthodontic teeth alignment using clear aligners at different time intervals (20min ,48h, 72h and 1 month) of fitting the second aligner (first active aligner).
  • Compare the PBF changes between the above two different types of orthodontic appliances (fixed appliances and the clear aligners).

详细描述

Aims: to evaluate the pulpal blood flow (PBF) during orthodontic teeth alignment and leveling using clear aligners (second aligner) and fixed orthodontic appliance at different time intervals of orthodontic force application.

Materials and Methods

A total of 45 subjects were subdivided in two groups: group 1: 25 subjects treated with pre-adjusted edgewise fixed appliance with 0.014 inch NiTi as the alignment arch wire and group 2: 20 subjects treated using clear aligner. In both groups, PBF was measured for the upper right and the lower left using Laser Doppler Flowmetry at different time interval (20 minutes, 48 hours, 72 hours, 1 month) after the fitting of the arch wire in group one and after the delivery of the second aligner in group two.

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
  • 16 or more years old
  • Class I skeletal malocclusion
  • mild upper and lower arches 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

研究组 & 干预措施

Group 1- Alignment with fixed appliance

Active Comparator

A pre-adjusted edgewise fixed appliance (3M Gemini Uniteks, 0.022" Roth prescription brackets.Teeth alignment in this group started using round 0.014" NiTi arch wire. The 0.014" NiTi arch wire was placed into the slots of the brackets and tied with elastomers by figure of 8. During this stage, only tipping movement was applied.

干预措施: Orthodontic Alignment (Other)

Group 2- Alignment with clear aligners

Experimental

Clear aligner orthodontic appliance (EON, Eon Dental NV, Belgium). Teeth alignment with clear aligners.

干预措施: Orthodontic Alignment (Other)

结局指标

主要结局

Pulpal blood flow changes by the use of Laser Doppler Flowmeter (Moor lab, Moor instruments, UK) with a wavelength of 780 nm and a dental probe MP 13 (Moor instruments, UK; 2 fibers, 0.25 mm diameter, centers 0.5 mm spaced apart).

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

Principal Investigator - Main thesis supervisor

Jordan University of Science and Technology

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