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临床试验/NCT03139994
NCT03139994已完成不适用

One Habitual Chewing Side May Contribute to Chronic Temporomandibular Joint Disorder Pain

University of Santiago de Compostela1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年5月2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
30
试验地点
1
主要终点
Presence or not of symptoms of temporomandibular joint disorders according to DC/TMD

研究概览

简要总结

The cause of temporomandibular joint disorders remains unknown. It is considered multifactorial and includes physical (peripheral) and psychosocial (central) factors. It has been showed an association: a steeper condylar path, flatter lateral anterior guidance, and habitual chewing on the symptomatic side. This finding argues the possibility of causation of some of these characteristics. This double blind longitudinal study aims to assess if the presence of one habitual chewing side could contribute to temporomandibular joint disorders over time.

Method. Young adults with no signs or symptoms of TMD will be assessed. Participants with one chewing side (observed and interview); with steeper condylar path and lower lateral guidance angles will be considered consistent one side chewers, and this side will be considered more susceptible to suffer TMD. Mouth opening, hemispheric dominance and hemimandibular retrognathia will be considered as secondary pre-specified outcomes. Four years later, both TMJs of each participant presenting signs and/or symptoms will be evaluated according to DC/TMD.

研究设计

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

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

  • healthies
  • full dentates
  • normal occlusion
  • One habitual chewing side

排除标准

  • Severe malocclusion, dental decay, severe periodontal disease.
  • Pains from other origins or Orthodontics are not criteria for exclusion

结局指标

主要结局

Presence or not of symptoms of temporomandibular joint disorders according to DC/TMD

时间窗: At 3 years follow-up

Pain-intensity (0-10 VAS scale, Von Korf)

Change of maximal unassited jaw opening

时间窗: Baseline and 3 years follow-up

Maximum unassisted jaw opening or interincisal distance (from edge to edge) measured by a Boley gauge. Up 38 in females and up 40 mm in males are considered limited.

次要结局

  • Change of condylar paths angles inclination(Baseline and 3-4-years follow-up (end of the study))
  • Alteration of lateral dental guidance angles(Baseline and 4-years follow-up (end of the study))
  • Change of maximal comfortable jaw opening(Baseline and 4-years follow-up (end of the study))
  • Change of the habitual chewing side(Baseline and 3-4-years follow-up (end of the study))
  • Change of lateral deviation during maximal unassisted jaw opening(Baseline, 3 years follow-up)

研究者

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

Urbano Santana Penin, MD, DDS, PhD

PROFESSOR

University of Santiago de Compostela

研究点 (1)

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