Temporomandibular Joint and COVID-19

October 13, 2021 updated by: Nazife Begüm KARAN, Recep Tayyip Erdogan University Training and Research Hospital

Temporomandibular Joint Complains in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Eyalet/Yerleşke
      • Ri̇ze, Eyalet/Yerleşke, Turkey, 053100
        • Nazife Begüm Karan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who live in Rize/Turkey

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
Patients with CV-19 and not in the acute period. This group were then divided into two subgroups each according to ASA (American Society of Anesthesiologist) classification (ASA 1 and ASA 2).
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.

  1. Demographics Survey
  2. DC/TMD Symptom Questionnaire (SQ)
  3. Graded Chronic Pain Scale (GCPS)
  4. Jaw Functional Limitation Scale-20 (JFLS-20)
Control Group
Patients without CV-19 This group were then divided into two subgroups each according to ASA (American Society of Anesthesiologist) classification (ASA 1 and ASA 2).
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.

  1. Demographics Survey
  2. DC/TMD Symptom Questionnaire (SQ)
  3. Graded Chronic Pain Scale (GCPS)
  4. Jaw Functional Limitation Scale-20 (JFLS-20)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion an average of 3 months
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.
through study completion an average of 3 months
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
through study completion an average of 3 months
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)
through study completion an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ASA 1
Time Frame: through study completion an average of 3 months
American Society of Anesthesiologist 1 - systemically healthy patients
through study completion an average of 3 months
ASA 2
Time Frame: through study completion an average of 3 months
American Society of Anesthesiologist 2 - A patient with mild systemic disease
through study completion an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Investigators

  • Principal Investigator: Nazife B Karan, Recep Tayyip Erdogan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 14, 2021

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data that support the other findings in this study are available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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