Temporomandibular Joint and COVID-19

COVID-19 Clinical Trial

Official title:

Temporomandibular Joint Complains in Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077189
• Other study ID #: 2020/224
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: October 2021
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ASA Triad
• COVID-19
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) scale
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)

Locations

Country	Name	City	State
Turkey	Nazife Begüm Karan	Ri?ze	Eyalet/Yerleske

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DC/TMD scale - Demographics Survey	This survey consisted of 6 items concerning marital status, socioeconomic status, profession, education, and children.	through study completion an average of 3 months
Primary	DC/TMD scale - DC/TMD Symptom Questionnaire	This 14-item questionnaire aims to determine the duration and causes of pain and the associated symptoms.	through study completion an average of 3 months
Primary	DC/TMD scale - Graded Chronic Pain Scale	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	through study completion an average of 3 months
Primary	DC/TMD scale - Jaw Functional Limitation Scale-20	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)	through study completion an average of 3 months
Secondary	ASA 1	American Society of Anesthesiologist 1 - systemically healthy patients	through study completion an average of 3 months
Secondary	ASA 2	American Society of Anesthesiologist 2 - A patient with mild systemic disease	through study completion an average of 3 months