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临床试验/NCT04376645
NCT04376645已完成不适用

A Comparative Assessment of Occlusal Bite Force Changes After Surgical Correction of the Increased Vertical Dimension in Mandibular Prognathism Subjects: A Prospective Clinical Trial

Jordan University of Science and Technology1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Occlusal bite force

研究概览

简要总结

The aim of this study was to record the OBF changes after surgical correction of mandibular prognathism in patients with or without increased vertical skeletal dimensions at different time intervals (T0: before surgery; T1: at debond; T2: 3 months post-retention).

详细描述

Forty-two patients who presented to orthodontic clinics with severe Class III skeletal malocclusion and were already into orthodontic preparation for orthognathic surgery were selected to participate in thestudy.

Patients were allocated into one of 2 groups as follows: - Group 1: - Class III patients with increased vertical relationship Included 22 patients (8 males, 14 females).These patients were scheduled for bimaxillary surgical procedures (Maxillary advancement and mandibular setback with posterior maxillary impaction) to correct the antero-posterior and vertical skeletal discrepancies.

Group 2: - Class III subjects with normal vertical relationship Included 20 patients (8 males, 12 females).These patients were scheduled for mandibular setback surgical procedure (with no posterior maxillary impaction) to correct the antero-posterior skeletal discrepancy.

Diagnostic records (orthopantomogram, lateral cephalogram, study casts, clinical photographs) were taken for all subjects before surgery. The same records were taken post surgery just before fixed orthodontic appliance debond.

The included patients were treated by orthodontic teaching staff and postgraduate residents at orthodontic clinics/JUST using pre-adjusted edgewise fixed appliance (3M Gemini Uniteks, 0.022" MBT prescription brackets).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Blinding was not possible

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • adults ≥18 years
  • severe skeletal class III malocclusion
  • patients willing to undergo surgery
  • no systematic medical conditions

排除标准

  • poor oral hygiene
  • heavily restored or endodontically treated first molars

结局指标

主要结局

Occlusal bite force

时间窗: 1 year

measured bilaterally in the first molar region using a portable occlusal force gauge

Number of teeth in contact

时间窗: 1 year

measured using double-sided articulation paper strips that was smeared with a thin layer of petroleum jelly

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

Elham Abu Alhaija

Professor

Jordan University of Science and Technology

研究点 (1)

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