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临床试验/NCT02752347
NCT02752347Unknown不适用

An Electromyography Study Comparing the Impact of Using RMEs on Muscle Activity Among Growing Orthodontic Patients (A Prospective Clinical Study)

Riyadh Colleges of Dentistry and Pharmacy2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
measuring the masticatory muscles activity using electromyography device

研究概览

简要总结

Compare the impact of using rapid maxillary expanders on masticatory muscle activities (Masseter and Anterior Temporalis muscles) among different posterior cross-bite patient (unilateral, bilateral) as well as compare the cross-bite side and non-cross-bite sides of the same preadolescent unilateral crossbite patient before the expansion and after one month of the completion treatment period using surface electromyography device.

详细描述

Compare the impact of using rapid maxillary expanders on masticatory muscle activities (Masseter and Anterior Temporalis muscles) between the cross-bite side and non-cross-bite sides of the same preadolescent orthodontic patient before the expansion and after one month of the completion treatment period.

Two channels surface Electromyography sEMG (BioRadio), will be position to record the activity of anterior temporal (AT) and masseter (MM) muscles in three different statuses:

  • Rest → patients will instruct to not bite on his/her teeth.
  • Clench → patients will instruct to made a maximum voluntary clench on cotton rolls positioned around the first molar, for 5 sec "the cotton clench", and a maximum voluntary clench without the interposed rolls for 5 sec "the "clench".

* This procedure followed the Sforza et al. protocol.

  • During function "mastication" → The patients will instruct to chew on a chewing gum for 20 sec (20 continuous masticatory cycles).

Examination frequency:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

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

入选标准

  • Uni-lateral/ or bilateral posterior cross-bite.
  • Patients with erupted permanent maxillary and mandibular first molars.
  • Will be treated by rapid maxillary expanders, (the appliance planning to be worn for approximately 5 months).
  • Age ranged from 9 to
  • Males and females.
  • Not under any medications.
  • Skeletal Class I or Class II (based on ANB angle, convexity, and Wits appraisal).
  • No active caries.
  • Healthy periodontal tissues.
  • Subjects with no signs of TMD or condylar problems.

排除标准

  • History of any functional appliance treatment.
  • Oral, systemic disease or any syndromes.
  • Patients under any medications.
  • 6. Patients with symptoms of Temporomandibular disorders.
  • Neuropathic conditions.
  • Open and deep-bite.

结局指标

主要结局

measuring the masticatory muscles activity using electromyography device

时间窗: Test 1: before cementation of rapid maxillary expander, Test 2: after removal of rapid maxillary expander by 1 month

the muscle activities of masticatory muscles using surface Electromyography device before and compare it after the maxillary expansion using Rapid Maxillary Expanders (to study the impact of the expanders on the muscles), the muscle activity will be in form of micro volt/second (mV/sec), the data will aggregated then exported on excel sheet in a form of numbers for statistical analysis

次要结局

未报告次要终点

研究者

发起方
Riyadh Colleges of Dentistry and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nancy Ajwa

Resident

Riyadh Colleges of Dentistry and Pharmacy

研究点 (2)

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