Temporomandibular Joint and COVID-19

NCT05077189 | Completed DMC

• 1 other identifier: 2020/224
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Temporomandibular Disorder; ASA Triad

Keywords

coronavirus; TMJ disorder; DC/TMD; ASA; Sars-CoV-2

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• ASA 1

  through study completion an average of 3 months

• ASA 2

  through study completion an average of 3 months

Study Arms (2)

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

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

Interventions

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. 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; Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who live in Rize/Turkey

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

Nazife Begüm Karan

Rize, Eyalet/Yerleşke, 053100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Temporomandibular Joint Disorders; Asthma, Nasal Polyps, And Aspirin Intolerance; Coronavirus Infections

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Nazife B Karan

  Recep Tayyip Erdogan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor, DDS, PhD

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 14, 2021
• Study Start: December 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

TU (1)