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临床试验/NCT05782088
NCT05782088已完成不适用

Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement: a Randomized Controlled Clinical Trial

Nourhan M.Aly2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023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
发起方
入组人数
30
试验地点
2
主要终点
Measurement of molar anchorage loss

研究概览

简要总结

The primary aim of the study is to evaluate the effect of single and repeated piezocisions on the rate of orthodontic tooth movement. Secondary aims are to evaluate the effect of both protocols on molar anchorage loss, as well as on canine root resorption.

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

入选标准

  • Malocclusion that requires at least the extraction of maxillary first premolars, such as Class I bimaxillary protrusion, and Class II division 1 cases.
  • Normal shape and structure of the maxillary canines, with no history of root canal treatment

排除标准

  • Patients who underwent previous orthodontic treatment.
  • Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.

研究组 & 干预措施

Repeated Piezocision

Experimental

干预措施: Repeated Piezocision (Procedure)

Single Piezocision

Experimental

干预措施: Single Piezocision (Procedure)

结局指标

主要结局

Measurement of molar anchorage loss

时间窗: 12 weeks

Perpendicular lines will be drawn from the central fossae of both maxillary right and left first molars to the mid-palatal raphe. Consequently, molar anchorage loss will be calculated by measuring the distance between those lines, and the lines representing the third rugae as previously mentioned.

Measurement of canine root resorption

时间窗: 12 weeks

Root resorption of the maxillary canines will be evaluated and measured by comparing pre-retraction and post-retraction CBCT scans.

Alveolar bone volume

时间窗: 12 weeks

From the pre- and post-retraction CBCTs (at T0 and T1), bone volume in areas of the maxillary alveolar process surrounding the canines will be measured using a special software.

Measurement of canine retraction

时间窗: 12 weeks

Several landmarks will be identified on the dental arch, including the mid-palatal raphe, the most medial points on the third right and left rugae, and the cusp tips of the right and left maxillary canines. Perpendicular lines will be drawn from the medial points of the right and left third rugae, and the cusp tips of the right and left maxillary canines to the mid-palatal raphe. The antero-posterior measurements will be carried out between the canine lines and the third rugae lines bilaterally, to assess the rate of canine retraction.

Bone Microstructure (Fractal Dimension)

时间窗: 12 weeks

Using the collected CBCT scans, the region of interest will be selected within the maxillary alveolar process, and the fractal dimension analysis will be performed using a special software for the maxillary canines in the experimental and control groups.

Alveolar bone density

时间窗: 12 weeks

From the acquired pre- and post-retraction CBCTs, bone density will be measured form a coronal cross-section of the maxillary arch around each canine in the experimental and control groups.

Alveolar bone thickness

时间窗: 12 weeks

The buccal bone thickness will also be measured at three points from the buccal bone to the root, at the coronal, mid-root, and apical level for each maxillary canine

Maxillary canine tipping

时间窗: 12 weeks

Tipping of the maxillary canine during retraction was evaluated by drawing vertical lines on the palatal surfaces of the lateral incisor and the canine that extend from the middle of the incisal edge of the lateral incisor and the cusp tip of the maxillary canine to the middle of the cervical line of each, thereby dividing each of them into equal halves. The distance between the lateral incisor and the canine was assessed at two points on their clinical crowns: incisal, and cervical, enabling the detection of crown tipping of the canine during retraction if there was a difference in the measurements between the both the assessed levels.

次要结局

未报告次要终点

研究者

发起方
Nourhan M.Aly
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nourhan M.Aly

Assistant Lecturer of Dental Public Health

University of Alexandria

研究点 (2)

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