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Completed

NCT Number: NCT05077189

Temporomandibular Joint and COVID-19

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) scale

Other

4 items of the DC/TMD scale were used in this study to evaluate the TMJ disorders.

  • Demographics Survey
  • DC/TMD Symptom Questionnaire (SQ)
  • Graded Chronic Pain Scale (GCPS)
  • Jaw Functional Limitation Scale-20 (JFLS-20)

Primary outcomes

  1. DC/TMD scale - Demographics Survey

    Time frame: through study completion an average of 3 months

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

  2. DC/TMD scale - DC/TMD Symptom Questionnaire

    Time frame: 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.

  3. DC/TMD scale - Graded Chronic Pain Scale

    Time frame: 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

  4. DC/TMD scale - Jaw Functional Limitation Scale-20

    Time frame: 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)

Secondary outcomes

  1. ASA 1

    Time frame: through study completion an average of 3 months

    American Society of Anesthesiologist 1 - systemically healthy patients

  2. ASA 2

    Time frame: through study completion an average of 3 months

    American Society of Anesthesiologist 2 - A patient with mild systemic disease

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

Temporomandibular Joint Complains in Patients With COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2021
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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