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临床试验/NCT04902456
NCT04902456Unknown不适用

Evaluation of the Anchorage Loss During En-masse Retraction in Orthodontic Patients With Maxillary Protrusion Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial

Future University in Egypt1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月29日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Anchorage loss

研究概览

简要总结

There is scarcity in literature regarding the effectiveness of friction and frictionless mechanics during ''En-masse retraction''technique on anchorage loss of posterior segment in orthodontic patients with maxillary protrusion. Moreover there is deficiency in studies measuring the patient pain and satisfaction regarding the different techniques of retraction.

The aim of the current study is to evaluate the effects of friction versus frictionless mechanics, implemented during "En-masse retraction", on anchorage loss. Additionally, assessment of both techniques regarding their rates, effects on root resorption as well as patient satisfaction.

详细描述

One of the most common complaints of orthodontic patients is proclination of anterior teeth where there is an increase in facial convexity and as well as incompetent lips. Bimaxillary dentoalveolar protrusion and class II division I cases always have this appearance. Frequently this situation requires extraction of the first premolars followed by fixed orthodontic appliance for space closure and retraction of anterior teeth. Different techniques are used including "Two-step retraction" where canines are retracted as a first step followed by anterior four incisors as a second step and "En-masse retraction" where anterior teeth are retracted as one unit. However, the method of "En-masse retraction" is controversial - whether to use frictionless or friction mechanics.

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)

盲法说明

Only the outcome assessors will be blind. The patients name will be sealed from pre and post radiographs and study models. Then two assessors will carry out, blindly and independently, the measurements and analysis of the study

入排标准

年龄范围
14 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Orthodontic patients (both genders)
  • Age range (14-24)
  • Patients requiring 1st premolars extraction followed by ''En-masse retraction'' (Bimaxillary Protrusion or Class II division 1 cases).
  • Patients with fully erupted permanent teeth (not necessarily including the 3rd molar).
  • Cases requiring maximum anchorage during anterior segment retraction.
  • Cases with minimal crowding (2-3) mm

排除标准

  • Patients suffering from any systemic diseases interfering with tooth movement.
  • Patients with extracted or missing permanent teeth. (except for third molars).
  • Patients with badly decayed teeth.
  • Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc....).
  • Patients with previous orthodontic treatment

结局指标

主要结局

Anchorage loss

时间窗: from pre to post retraction/intervention ( an average of 6-8 months )

Digitally scanned dental models taken pre and post completion of retraction will be measured by identifying landmarks and reference lines and planes ( measured in mm )

次要结局

  • Retraction Rate(from pre to post retraction/intervention ( an average of 6-8 months ))
  • Pain of Intervention(from pre to post retraction/intervention ( an average of 6-8 months ))
  • Anterior teeth torque(from pre to post retraction/intervention ( an average of 6-8 months ))
  • Anterior teeth tip(from pre to post retraction/intervention ( an average of 6-8 months ))
  • Molar Rotation(from pre to post retraction/intervention ( an average of 6-8 months ))
  • Anterior teeth extrusion/intrusion(from pre to post retraction/intervention ( an average of 6-8 months ))

研究者

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

Amr Mahmoud Attia

Principle Investigator

Future University in Egypt

研究点 (1)

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