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临床试验/NCT05077189
NCT05077189已完成不适用

Temporomandibular Joint Complains in Patients With COVID-19

Recep Tayyip Erdogan University Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
1
主要终点
DC/TMD scale - Jaw Functional Limitation Scale-20

研究概览

简要总结

There is evidence that CV-19 is associated with joint symptoms, but there are no specific data on the temporomandibular joint (TMJ). It is also known that the systemic health status can impact the immune system. Given all this, this study aimed to investigate the effect of CV-19 and systemic health status, as determined by the American Society of Anesthesiologists (ASA) Physical Status Classification System 12, on TMJ in patients with TMJ complaints using the DC/TMD scale.

详细描述

This study investigates the effect of systemic status, according to American Society of Anesthesiologist (ASA), and COVID-19 on temporomandibular joint (TMJ) disorders using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) scale, shown to be valid for assessing TMJ disorders. The study included 76 patients who presented to our clinic with TMJ. Participants were divided into two groups: those with COVID-19 (CV-19, study group) and those without (non-CV-19, control group). These two groups were both further divided into subgroups according to ASA 1 and ASA 2 classification. Power analyses were performed using G*Power software to determine the required number of patients. Groups were compared using the Symptom Questionnaire, a demographics survey, the Graded Chronic Pain Scale (GCPS), and the Jaw Functional Limitation Scale-20 (JFLS-20) of the DC/TMD. The statistical software program version 1.6.23 was used for statistical analysis. Although joint complaints were more common in ASA 2 patients with CV-19, the groups were not significantly different. The CV-19 ASA 2 group had the highest JFLS-20 score (mean: 1.3±1.5) and the non-CV-19 ASA 1 group had the lowest JFLS-20 score (mean: 0.7±0.8), but the differences were again not significant. Joint complaints were more common and more severe in ASA 2 patients with CV-19, albeit not with statistical significance. More studies are needed to better understand our results.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •applied to our clinic with TMJ discomfort
  • •ASA 1 and ASA 2 patients

排除标准

  • •patients with acute CV-19
  • •Patients who are not in ASA 1 or ASA 2 classification
  • •Patients under 18 year-old
  • •Pregnants

结局指标

主要结局

DC/TMD scale - Jaw Functional Limitation Scale-20

时间窗: through study completion an average of 3 months

This scale consists of three subscales that address limitations of mastication, vertical mobility, and verbal and non-verbal communication. These three subscales are ideal for both research purposes and patient assessment of various functional limitations of the jaw. It is a global scale that consists of 20 items and the three aforementioned subscales (mastication, vertical mobility, and verbal and non-verbal communication)

DC/TMD scale - Demographics Survey

时间窗: through study completion an average of 3 months

This survey consisted of 6 items concerning marital status, socioeconomic status, profession, education, and children.

DC/TMD scale - DC/TMD Symptom Questionnaire

时间窗: through study completion an average of 3 months

This 14-item questionnaire aims to determine the duration and causes of pain and the associated symptoms.

DC/TMD scale - Graded Chronic Pain Scale

时间窗: through study completion an average of 3 months

This 8-item scale is graded on a scale of 0-10 points. It includes 3 questions on pain intensity, 4 questions on function, and 1 question on the number of days with facial pain. The GCPS consists of two subscales. As the first subscale, Characteristic Pain Intensity is measured, where a score of ≥50 out of 100 possible points indicates high-intensity pain. The Interference Score is then calculated as the second subscale based on scores concerning interference in daily activities and work and the number of days with interference

次要结局

  • ASA 1(through study completion an average of 3 months)
  • ASA 2(through study completion an average of 3 months)

研究者

发起方
Recep Tayyip Erdogan University Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazife Begüm KARAN

Associated Professor, DDS, PhD

Recep Tayyip Erdogan University Training and Research Hospital

研究点 (1)

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