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临床试验/NCT03089996
NCT03089996已完成不适用

Piezocision, Corticotomy and Micro-ostoeperforations to Accelerate Orthodontic Tooth Movement

Pontifícia Universidade Católica de Minas Gerais2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Orthodontic Canine Retraction Rate

研究概览

简要总结

This study will compare the techniques of piezocision and alveolar corticotomies in accelerating orthodontic retraction movement of canines. In a second phase, this clinical trial will evaluate the effectiveness of micro-osteoperforations in accelerating the retraction of maxillary incisors.

详细描述

The first phase will consist of a split-mouth study in patients who require the extraction of the first premolars to correct malocclusion. The canine will be retracted using corticotomy and piezocision surgical techniques, as well as without any intervention, being this the control side. In addition, it will be evaluated the inflammatory biomarkers present in the gingival crevicular sulcus during the dental movement, as well as data related to pain and discomfort. The second phase will evaluate the effects of micro-osteoperforations in the retraction of maxillary incisors. The following parameters will be evaluated in the upper arch: anteroposterior incisors and first molars displacement, space closure, inclination and length of central incisors.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with orthodontic need for bilateral upper first premolar extraction.
  • Adequate dento-oral health
  • ASA I and ASA II
  • Compliance with clinic visits every 2 weeks

排除标准

  • History of periodontal disease
  • Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
  • Pregnancy
  • Presence of cleft or any syndrome

结局指标

主要结局

Orthodontic Canine Retraction Rate

时间窗: Up to 6 months

The main objective is to evaluate and compare the canine retraction velocity in the different groups. Digital intra-oral scans will be performed (3Shape A / S®, Kopenhagen, Denmark) as registration method, every 14 days, up to 6 months.

Anteroposterior displacement of the upper incisors

时间窗: Up to 4 months

The anteroposterior displacement of the upper incisors was assessed on superimposed digital models through the distance of points on the incisal edge and palatal cervical margin of these teeth to a coronal reference plan created on the initial CBCT scan.

Space closure

时间窗: Up to 4 months

The space closure was assessed by the distance between the most menial point of the medial surface of the canine to the most distal point of the distal surface of the lateral incisor.

次要结局

  • Changes of the length of the central incisors(Up to 4 months)
  • Duration of the effect of the surgical procedures(Up to 6 months)
  • Evaluation of biomarkers(Up to 6 months)
  • Patient Pain and discomfort(Up to 6 months)
  • Changes of the inclination of the central incisors(Up to 4 months)
  • First molars anchorage loss(Up to 4 months)

研究者

发起方
Pontifícia Universidade Católica de Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodrigo Villamarim Soares

Clinical Professor

Pontifícia Universidade Católica de Minas Gerais

研究点 (2)

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