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临床试验/NCT03180671
NCT03180671Unknown不适用

The Effectiveness of Anterior Deprogrammers as a Tool for Reducing Pain and Masticatory Muscles Tension

Lukasz Adamczyk1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Electromyography

研究概览

简要总结

The study will be conducted in four groups of 20 patients in age of 20-30 years with complete dentition or single tooth loss in lateral regions, with masticatory muscle pain in the history or during examination and overuse and/or chronic tensing of the masticatory muscles. Patients will be randomly assigned to the groups.

Each person will be measured twice before and after use of selected anterior deprogrammer. The following assessment tools will be applied:

  • surface electromyography of masseter and temporal muscles,
  • intraoral pin-supported registration to draw a gothic arch.

Measurements will be made before and after intervention to assess the effect of anterior deprogrammer application on the tone of the selected masticatory muscles and condyles position in mandibular fossa. The first group (control) will be counsel with an explanation of the pathomechanism of masticatory muscles pain and preventive principles. In the second group, the Sliding Guide will be used for a period of 12-15 minutes, in the third Dawson B-Splint for 7 days, and in the fourth Kois deprogrammer for 14 days. Devices in group 3 and 4 will be used by patients for 24 hours a day, with breaks for oral hygiene procedures and eating/drinking.

The aim of the study is to evaluate the effectiveness of selected anterior deprogrammers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •age 20-30 years old
  • •complete dentition or single tooth loss in the lateral regions
  • •no severe systemic diseases
  • •masticatory muscle pain in the history or during examination
  • •increased masticatory muscles tension

排除标准

  • 未提供

研究组 & 干预措施

Group 1 Control

No Intervention

Counselling with explanation of preventive procedures.

Group 2 deprogramer Sliding Guide

Active Comparator

Intervention using the Deprogrammer Sliding Guide for 12-15 minutes.

干预措施: Deprogramer Sliding Guide (Device)

Group 3 deprogrammer Dawson B-Splint

Active Comparator

Intervention using the Dawson B-Splint for 7 days with breaks for eating/drinking and oral hygiene procedures.

干预措施: Deprogrammer Dawson B-Splint (Device)

Group 4 deprogrammer Kois

Active Comparator

Intervention using the Kois deprogrammer for 14 days with breaks for eating/drinking and oral hygiene procedures.

干预措施: Deprogrammer Kois (Device)

结局指标

主要结局

Electromyography

时间窗: 2 min

Examination of masseters and temporal muscles tension

次要结局

  • Centric relation(5 min)

研究者

发起方
Lukasz Adamczyk
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lukasz Adamczyk

Principal investigator

Wroclaw Medical University

研究点 (1)

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