Clinical trial NCT05077189: Temporomandibular Joint and COVID-19
Official title: Temporomandibular Joint Complains in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Temporomandibular Disorder
ASA Triad
Keywords: coronavirus
TMJ disorder
DC/TMD
ASA
Sars-CoV-2
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who live in Rize/Turkey

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: DC/TMD scale - Demographics Survey
timeFrame: through study completion an average of 3 months
measure: DC/TMD scale - DC/TMD Symptom Questionnaire
timeFrame: through study completion an average of 3 months
measure: DC/TMD scale - Graded Chronic Pain Scale
timeFrame: through study completion an average of 3 months
measure: DC/TMD scale - Jaw Functional Limitation Scale-20
timeFrame: through study completion an average of 3 months
Secondary outcomes:
measure: ASA 1
timeFrame: through study completion an average of 3 months
measure: ASA 2
timeFrame: through study completion an average of 3 months
Other outcomes:
Locations:
city: Ri̇ze
country: Turkey
facility: Nazife Begüm Karan
state: Eyalet/Yerleşke
Study officials:
affiliation: Recep Tayyip Erdogan University
name: Nazife B Karan
role: PRINCIPAL_INVESTIGATOR
References: