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临床试验/NCT04905004
NCT04905004Unknown不适用

Comparing Canine Retraction Using Two-week, Four-week, Six-week and Eight-week Reactivation Intervals

Future University in Egypt1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
56
试验地点
1
主要终点
Rate of canine retraction

研究概览

简要总结

Canine retraction after 1st premolar extracion into the extraction space is a routine treatment in orthodontics. Orthodontic patients requiring first premolar extraction, canine retraction and maximum anchorage were recruited for this randomized controlled trial. A search of the literature did not indicate the ideal frequency of elastomeric chain reactivation for optimum canine retraction. The study was approved by the ethical committee. The first premolars were extracted. Elastomeric chains were used to retract the canine distally into the 1st premolar space. The optimum reactivation interval was evaluated regarding the efficiency of treatment in terms of rate of canine retraction, canine tipping and rotation, root resorption and pain at the intervals of 2, 4, 6 and 8 weeks. Three dimensional imaging, as well as digital scanning were the methods for data collection.

详细描述

The canines, 2nd premolars, 1st molars and 2nd molars were bonded and banded. Leveling and alignment was achieved. After the first premolar extraction, temporary anchorage devices were inserted interradicular between 2nd premolar and 1st molar. Canine retraction was performed on a 0.016" X 0.022" stainless steel arch wire. A power arm was extended to apply the force closer to the center of resistance and achieve bodily movement. Elastomeric chains were calibrated to deliver a force of 150g and extended from the power arm to the mini screws directly. Recruited patients were randomly allocated to four groups according to the duration between the elastomeric chain reactivation. Canine reactivation intervals were 2, 4, 6, or 8 weeks. Cone beam computed tomography was performed before canine retraction and after 6 months of retraction. Digital dental casts were taken before canine retraction and monthly for 6 months.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Patients requiring 1st premolar extraction (e.g bimaxillary dentoalveolar protrusion)
  • •Erupted full set of permanent teeth (excluding 3rd molars)

排除标准

  • •Systemic diseases that would interfere with bone metabolism
  • •Craniofacial syndromes
  • •congenitally missing or extracted permanent teeth.
  • •periodontally compromised patients
  • •pregnant women
  • •previous orthodontic treatment

研究组 & 干预措施

2-week reactivation interval

Experimental

Replacement of elastomeric chain every 2 weeks and reestablishing a 150 g force

干预措施: Canine retraction (Procedure)

4-week reactivation interval

Active Comparator

Replacement of elastomeric chain every 4 weeks and reestablishing a 150 g force

干预措施: Canine retraction (Procedure)

6-week reactivation interval

Experimental

Replacement of elastomeric chain every 6 weeks and reestablishing a 150 g force

干预措施: Canine retraction (Procedure)

8-week reactivation interval

Experimental

Replacement of elastomeric chain every 8 weeks and reestablishing a 150 g force

干预措施: Canine retraction (Procedure)

结局指标

主要结局

Rate of canine retraction

时间窗: 5 months to 6 months.

The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.

Rate of canine retraction

时间窗: Baseline to 1 month

The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.

Rate of canine retraction

时间窗: 1month to 2 months

The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.

Rate of canine retraction

时间窗: 2 months to 3 months

The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.

Rate of canine retraction

时间窗: 3 months to 4 months

The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.

Rate of canine retraction

时间窗: 4 months to 5 months

The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.

次要结局

  • First molar anchorage loss(Baseline to 6 months)
  • Canine tipping(Baseline to 6 months)
  • Canine root resorption(Baseline to 6 months)
  • Canine rotation(Baseline to 6 months)
  • Amount of canine retraction(Baseline to 6 months)
  • Pain score(Baseline to day 10.)
  • Pain score(baseline to day 1)
  • Pain score(Baseline to day 2)
  • Pain score(Baseline to day 3)
  • Pain score(Baseline to day 4)
  • Pain score(Baseline to day 5)
  • Pain score(Baseline to day 6)
  • Pain score(Baseline to day 7)
  • Pain score(Baseline to day 8)
  • Pain score(Baseline to day 9)

研究者

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

Yehya Mostafa

Head of the Orthodontics Department

Future University in Egypt

研究点 (1)

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