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临床试验/NCT06352996
NCT06352996进行中(未招募)不适用

Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm: A Split-Mouth Randomized Controlled Trial

Mansoura University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
2
主要终点
Canine tipping

研究概览

简要总结

Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.

Materials and methods:Twenty patients with age range between 14 to 25 years. Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment then The first premolars will be extracted and mini-implant will be inserted.

Canine retraction using nickel titanium closed coil spring will start in the same day of upper first premolar extraction.

详细描述

Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.

Participant and eligibility criteria:

Twenty patients will be recruited from the Department of Orthodontics at Mansoura University Pre-treatment records will be taken including: Intraoral and extraoral photographs, panoramic radiographs, cephalometric radiographs, and study models.

Intervention:

Written and informed consents will be taken from the patients. All patients will start the treatment by bonding fixed appliance (preadjusted edgewise, 0.018-in. slot, Roth prescription). Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment will be performed until reaching 0.017×0.025-in. nickel titanium arch wire. After 4 weeks of using the 0.017×0.025 arch wire, canine retraction phase will be initiated on 0.016×0.022 stainless steel arch wire.

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
14 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Class II div 1 patients with age range between 14 to 25 years
  • patients indicated for maxillary first premolar extraction
  • increased over jet
  • mild or no crowding in maxilla
  • no previous orthodontic treatment
  • no history of periodontal disease or bone loss
  • good oral hygiene
  • no systemic disease
  • absence of canine morphological abnormalities.

排除标准

  • patients not indicated for maxillary first premolar extraction
  • decreased or no over jet
  • moderate or severe crowding in maxilla
  • previous orthodontic treatment
  • history of periodontal disease or bone loss
  • bad oral hygiene
  • systemic disease
  • canine morphological abnormalities.

结局指标

主要结局

Canine tipping

时间窗: 4 months

Intraoral scanning for maxillary arch will be recorded every month for each patient; at T0 (Immediately before canine retraction), T1 (after 1 month), T2 (2 months), T3 (3 months) and T4 (4 months). The four obtained digital models from each patient will be separately superimposed on each other. The change in the mesiodistal crown angulation of the canine will be calculated at each time point.

Pain assessment

时间窗: 1 week

Pain assessment will be recorded by the visual analog scale (VAS) form. The participants will be informed to accomplish a visual analog scale diary containing 4 different times: four hours, 24 hours, 72 hours, and one week, following the beginning of the canine retraction. The pain level was on the 10-cm (100-mm) visual analog scale forms, with 0 (minimum) denoting no pain, while 100 (maximum) denoting sever pain.

canine rotation

时间窗: 4 months

Intraoral scanning for maxillary arch will be recorded every month for each patient; at T0 (Immediately before canine retraction), T1 (after 1 month), T2 (2 months), T3 (3 months) and T4 (4 months). The four obtained digital models from each patient will be separately superimposed on each other. The change in rotation of the canine will be calculated at each time point.

canine retraction rate

时间窗: 4 months

Intraoral scanning for maxillary arch will be recorded every month for each patient; at T0 (Immediately before canine retraction), T1 (after 1 month), T2 (2 months), T3 (3 months) and T4 (4 months). The four obtained digital models from each patient will be separately superimposed on each other. The retraction rate will be analyzed monthly and the total amount of canine retraction rate will be measured from cusp tip of the canine T0 to the same point in T4 for both sides.

Canine mobility

时间窗: 4 months

The Periotest device will be used to measure the mobility of the canine immediately before retraction and repeated monthly for 4 months.

Implant stability

时间窗: 4 months

The Periotest device will be used to measure the stability of the mini-implant immediately before retraction and repeated monthly for 4 months.

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

Anas Kassas

Dentist Anas Kassas

Mansoura University

研究点 (2)

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