Factors Affecting Patients With Myofascial Temporomandibular Disorders
2021年4月8日 更新者：Aysenur Tuncer、Hasan Kalyoncu University
Comparison of Factors Affecting Patients With a Myofascial Temporomandibular Disorder With and Without Sleep Bruxism
The aim of the study was to assess and compare the relationship between jaw function, neck disability, sleep quality, fatigue, and headache in patients with myofascial Temporomandibular Disorder (TMD) with Sleep Bruxism (SB) and without (non-SB).
研究概览
地位
完全的
干预/治疗
详细说明
The study was conducted on TMD patients who were willing to participate in the study between January and December 2020.
The case-control study included patients diagnosed with myofascial TMD by dental practitioners at regional hospitals referred for physiotherapy. Total of 200 myofascial TMD patients, comprising 91 identified as SB and 109 as non-SB were included in the study.
The Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales and indexes were used for both groups.
The effect of Sleep Bruxism (SB) on jaw function, neck problems, sleep quality, fatigue, and tension headache were evaluated.
The interactions of these factors and the importance of taking SB into consideration when evaluating and treating patients with TMD were examined.
研究类型
观察性的
注册 (实际的)
200
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Gaziantep、火鸡
- Abdulkadir Konukoglu Healthy Life Center
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Şanlıurfa、火鸡
- Umut Rehabilitation Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients with a chief complaint of pain and functional limitation at the temporomandibular region were assessed by dentists at regional hospitals.
Those who were diagnosed with myofascial TMD according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) participated in the study.
描述
Inclusion Criteria:
- diagnosis of myofascial TMD according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- pain for more than 6 months
- no therapeutic interventions reported for TMD or the neck in the last 6 months
- intellectual capacity to provide informed consent
Exclusion Criteria:
- not meeting the DC/TMD criteria
- diagnosis of psychiatric disease
- history of surgery related to the cervical region and/or TMJ
- cervical and/or TMJ malignancy
- trauma history
- proven specific pathologies such as fracture, or rheumatoid disease
- history of facial paralysis
- pregnancy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Myofascial Temporomandibular Disorder (TMD) with Sleep Bruxism (SB)
Patients with Myofascial TMD and with sleep bruxism with the diagnosis of regular or frequent teeth grinding sounds during the sleep, and one or more following clinical signs, such as jaw muscle pain or fatigue on waking up in the morning, temporal headache, hypertrophy of the masseter muscle, abnormal tooth wear, and/or jaw locking were included in the group.
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Patients with TMD regardless of diagnosis with sleep bruxism were assessed with the Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales.
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|
Myofascial Temporomandibular Disorder (TMD) without Sleep Bruxism (SB)
Patients with Myofascial TMD without sleep bruxism were included in the group.
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Patients with TMD regardless of diagnosis with sleep bruxism were assessed with the Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Visual Analogue Scale
大体时间：Baseline
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The severity of pain in muscles was measured in centimeters using a 0-10 Visual Analogue Scales (VAS).
The scale ranges from 0 = "no pain at all" to 10 = "intolerable pain"
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Baseline
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Jaw Functional Limitation Scale
大体时间：Baseline
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The Jaw Functional Limitation Scale-20 was used to assess jaw function in the masticatory system.
The scale consists of a total of 20 items with three constructs.
Each item is scored from 0-10, with 0 indicating no restriction and 10, severe restriction.
A total of ≥5 indicates jaw function limitation.
|
Baseline
|
|
Neck Disability Index
大体时间：Baseline
|
Neck problems were assessed with Neck Disability Index (NDI).
It is a scale of 10 sections with total points ranging from 0-50.
Higher scores indicate severe pain, and a score of ≥5 indicates a neck disorder.
|
Baseline
|
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Pittsburgh Sleep Quality Index
大体时间：Baseline
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The sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI).
The scale comprises a total of 24 items in 7 sub-scales.
The total points of the 19 items that score from 0-21, with a total of ≥5 indicating poor sleep quality.
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Baseline
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Fatigue Severity Scale
大体时间：Baseline
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The effect of fatigue on functional and behavioral aspects was evaluated by the Fatigue Severity Scale (FSS).
The total score is calculated as the average of the 9 item scores -the lower the total score, the lower the fatigue level.
A cut-off value of ≥4 has been defined for fatigue
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Baseline
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Headache Impact Test
大体时间：Baseline
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The Headache Impact Test-6 (HİT-6) was used to assess the headache.
The 6 items scale evaluating the frequency, the degree of restriction to daily life and social life, and changes in the mood because of headache.
The total score 50-59 reflects important impact, and scores ≥60 indicate severe impact.
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Baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Aysenur Tuncer、Hasan Kalyoncu University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年1月13日
初级完成 (实际的)
2020年12月18日
研究完成 (实际的)
2021年2月25日
研究注册日期
首次提交
2021年4月8日
首先提交符合 QC 标准的
2021年4月8日
首次发布 (实际的)
2021年4月13日
研究记录更新
最后更新发布 (实际的)
2021年4月13日
上次提交的符合 QC 标准的更新
2021年4月8日
最后验证
2021年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.