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临床试验/NCT04549948
NCT04549948已完成不适用

Curve of Spee: Speed of Leveling Using Different Orthodontic Archwire Size and Material - A Randomized Clinical Trial

Jordan University of Science and Technology1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2018年12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
51
试验地点
1
主要终点
Curve of Spee depth changes during leveling

研究概览

简要总结

The objectives if this study was to evaluate the efficacy of 3 different rectangular archwires in the correction of the curve of Spee (COS), to record the time needed to level excessive COS in the mandibular arch using the 3 archwire sizes, to investigate the changes in intercanine and intermolar widths and arch length during leveling, to measure the arterio-posterior and vertical movement for the lower incisors and lower molars, to record pulpal blood flow and to detect the root resorption in the lower anterior teeth associated with leveling excessive COS using the 3 different archwires.

详细描述

Fifty one subjects with an excessive COS were included in this study. The subjects will be randomly divided into three groups; Group one (17 patients): leveling of COS using 0.017X0.025-inch stainless steel archwire. Group two (17 patients): leveling of COS using 0.019X0.025-inch stainless steel archwire. Group three (17 patients): leveling of COS using 0.021X0.025-inch Titanium molybdenum archwire.

In the three groups, a 5mm depth reverse COS will be inserted. Records consisted of lateral cephalograms (pre-treatment, at T0 and post-treatment), peri-apical radiographs (at T0 and at T5), study casts (pre-treatment and at each time point during the tudy). Patients will be followed up on monthly visits without removing leveling archwires where alginate impressions were taken for the lower arch. Pain scores during the first week of leveling will be recorded using visual analogue scale (VAS).The amount of COS correction in mm, changes in intercanine in mm, intermolar and arch length in mm, pain scores and lower incisors root resorptions in mm will be measured.

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

The patient was blinded to the intervention used. However, it was not possible to blind the clinician during treatment.

入排标准

年龄范围
16 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 16 years and ≤ 30 years
  • Overbite covering more than half of the lower incisor height
  • Curve of Spee ≥ 4 millimeters
  • Mild crowding in lower arch where non-extraction treatment is indicated.
  • Normally inclined or retroclined lower incisors
  • Averaged or reduced lower vertical height
  • Good oral hygiene and healthy periodontium
  • All permanent teeth are present except for the third molars

排除标准

  • Severe crowding in lower arch where extraction treatment is indicated.
  • Missing permanent molars or Premolars
  • Poor oral hygiene and Periodontal disease
  • Systemic health problems and medications were taken
  • History of previous orthodontic treatment

结局指标

主要结局

Curve of Spee depth changes during leveling

时间窗: 4 to 6 months

The change in Curve of Spee in millimetres

次要结局

  • Root Resorption(6 months)
  • Pain perception(one week)
  • Pulpal blood flow(one month)

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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