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临床试验/NCT03057262
NCT03057262已完成不适用

The Efficiency of Anterior Repositioning Splint for the Management of Pain Related to Temporomandibular Joint Disc Displacement With Reduction

Jagiellonian University0 个研究点目标入组 112 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
112
主要终点
Pain relief related to temporomandibular joint disc displacement with reduction

研究概览

简要总结

Intra-articular temporomandibular disorders are often related to pain in the area of temporomandibular joint, ear and temple. The aim of the study was to investigate the efficiency of anterior repositioning splints for the management of pain related to temporomandibular joint disc displacement with reduction.

详细描述

The research material consisted of 112 patients, aged 24 to 45 years, of both genders, who reported to the treatment in Consulting Room of Temporomandibular Joint Dysfunctions at the Jagiellonian University in Cracow, between 2014-2016, due to the pain and clicking of temporomandibular joints with comorbid hypertension of masticatory muscles. Subjects were examined according to the Diagnostic Criteria for Temporomandibular Disorders protocol and after inclusion with painful disc displacement with reduction and masticatory muscle contracture assigned randomly to the study or control group (56 patients in each). In the study group was used the anterior repositioning splint on the lower arch for 20 hour usage per 4 months. In the control group a non-invasive therapy was applied using biostimulation laser in the form of 12 session, performed every second day, on the area of the temporomandibular joints with opened mouth and performing muscles self-exercises with a dominant protrusive position of the mandible. Pain intensity was evaluated using verbal numerical rating scale (VNRS) immediately before the treatment and then after 4 and 16 weeks. The obtained data were analyzed using U Mann-Whitney test (p ≤ 0,005).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • unilateral or bilateral presence of clicking, popping and/or snapping noise(s) detected with palpation during opening or closing or lateral or protrusive movements in TMJ(s),
  • in the previous 30 days, any TMJ noise(s) present with jaw movement or function,
  • unilateral or bilateral pain in the area of temporomandibular joint,
  • presence of masticatory muscles contracture,
  • full dentition or single tooth loss,
  • good general health,
  • positive mandible protrusion test,
  • no contraindications for laser therapy
  • patient consent to be involved in the study.

排除标准

  • partial tooth loss or edentulism,
  • contraindications for laser therapy
  • absence of appropriate symptoms
  • absence of consent to be involved in the study

结局指标

主要结局

Pain relief related to temporomandibular joint disc displacement with reduction

时间窗: 16 weeks

Repositioning splint was applied to check its efficiency of pain relieving in a case of temporomandibular joint disc displacement with reduction.

次要结局

未报告次要终点

研究者

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Malgorzata Pihut

Associate Professor

Jagiellonian University

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