COVID-19NCT05077189
Temporomandibular Joint and COVID-19
An observational study of COVID-19 and Temporomandibular Disorder, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Temporomandibular Disorder, ASA Triad
- What is being tested?
- Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) scale
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 1 Jun 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who live in Rize/Turkey
Who may be able to join
- applied to our clinic with TMJ discomfort
- ASA 1 and ASA 2 patients
Who cannot join
- patients with acute CV-19
- Patients who are not in ASA 1 or ASA 2 classification
- Patients under 18 year-old
- Pregnants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nazife Begüm Karan
Rize, Eyalet/Yerleşke, 053100
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Temporomandibular Disorder, ASA Triad
- Being tested
- Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) scale
- Keywords
- coronavirus, TMJ disorder, DC/TMD, ASA, Sars-CoV-2
- Medical subject headings
- COVID-19, Temporomandibular Joint Disorders, Asthma, Nasal Polyps, And Aspirin Intolerance, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) scaleOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
DC/TMD scale - Demographics Survey
This survey consisted of 6 items concerning marital status, socioeconomic status, profession, education, and children.
Measured: 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.
Measured: 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
Measured: 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)
Measured: through study completion an average of 3 months
Secondary outcomes (2)
ASA 1
American Society of Anesthesiologist 1 - systemically healthy patients
Measured: through study completion an average of 3 months
ASA 2
American Society of Anesthesiologist 2 - A patient with mild systemic disease
Measured: through study completion an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Dec 2020
- Primary completion1 Mar 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazife Begüm KARAN, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Nazife B Karan, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077189
- Sponsor's protocol ID
- 2020/224
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data that support the other findings in this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporomandibular Joint Complains in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05077189
- Acronym / sponsor ID
- 2020/224
- Conditions
- COVID-19, Temporomandibular Disorder, ASA Triad
- Keywords
- coronavirus, TMJ disorder, DC/TMD, ASA, Sars-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) scalePatients 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). |
| Control Group | – | Other: Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) scalePatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who live in Rize/Turkey
Key inclusion criteria (2 listed)
- applied to our clinic with TMJ discomfort
- ASA 1 and ASA 2 patients
Key exclusion criteria (4 listed)
- patients with acute CV-19
- Patients who are not in ASA 1 or ASA 2 classification
- Patients under 18 year-old
- Pregnants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) scale4 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) | Other | Control Group, Study Group |
Primary outcome
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.
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.
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
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)
2 secondary outcomes
ASA 1
Time frame: through study completion an average of 3 months
ASA 2
Time frame: through study completion an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: Undecided. Data that support the other findings in this study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazife B Karan principal investigator
Recep Tayyip Erdogan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Temporomandibular Disorder, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DC/TMD scale - Demographics Survey (time frame: through study completion an average of 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.