Temporomandibular Joint and COVID-19

Sponsor
Recep Tayyip Erdogan University Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05077189
Collaborator
(none)
76
1
6
12.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Diagnostic Criteria for Temporomandibular Disorders (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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
76 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Temporomandibular Joint Complains in Patients With COVID-19
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. DC/TMD scale - Demographics Survey [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 [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 [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 [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 Outcome Measures

  1. ASA 1 [through study completion an average of 3 months]

    American Society of Anesthesiologist 1 - systemically healthy patients

  2. ASA 2 [through study completion an average of 3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nazife Begüm Karan Ri̇ze Eyalet/Yerleşke Turkey 053100

Sponsors and Collaborators

  • Recep Tayyip Erdogan University Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nazife Begüm KARAN, Associated Professor, DDS, PhD, Recep Tayyip Erdogan University Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05077189
Other Study ID Numbers:
  • 2020/224
First Posted:
Oct 14, 2021
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nazife Begüm KARAN, Associated Professor, DDS, PhD, Recep Tayyip Erdogan University Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 21, 2021