Temporomandibular DisorderNCT05183503
Determination of Chronic Pain, Anxiety, Depression and Perceived Stress in Adults With Temporomandibular Disorders
An observational study of Temporomandibular Disorder and Depression, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
The aim of the study was to asses levels and relationship of chronic pain, anxiety, depression and perceived stress in TMD patients . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Temporomandibular Disorder, Depression, Anxiety
- What is being tested?
- DC/TMD examination
- How many people
- 219 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the Outpatient Clinic for Temporomandibular Disorders at the Medical University in Wroclaw diagnosed with TMD using Diagnostic Criteria for Temporomandibular Disorders (DC / TMD).
Who may be able to join
- Inclusion criteria for this study were age equal or above 18 years old and diagnosis of TMD based on DC/TMD examination form.
Who cannot join
- The exclusion were severe neurological or mental diseases, taking medications that significantly affect the neuromuscular function, alcohol and/or drug addiction, active cancer diagnosis, pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of the study was to asses levels and relationship of chronic pain, anxiety, depression and perceived stress in TMD patients .
Read the detailed description
Temporomandibular disorders (TMD) is an umbrella term describing a heterogenic group of conditions concerning masticatory muscles, temporomandibular joints and surrounding hard and soft structures. Most common signs and symptoms of TMD are: orofacial pain, joint sounds such as clicking or crepitus and limitation in jaw movements . Temporomandibular disorder (TMD) is the most common cause of orofacial pain and after chronic low back pain, it is the second cause of pain and disability in the musculoskeletal system. TMDs are considered as a global problem decreasing quality of life and potentially causing chronic pain, in daily activity limitation, anxiety, depression, general health problems, decreased work productivity and can lead to work absences.
The etiology of TMD is complex, multifactorial, and in many cases unclear. The biopsychosocial model tends to cover a broad spectrum of different conditions and aspects that may play a role in TMD occurrence. It integrates biological factors (structural disorders and disturbance in function) with psychosocial aspects (emotions, cognition, behaviors, reaction to stress and pain in context of family, workplace and community) .
The prevalence of TMD is estimated between 5-12% of the general population . About 26-30% of young adults present at least one symptom of TMD . The prevalence of TMD in adults over 45 years old is estimated between 2-7%.and in patients over 65 years old 3-5% . It is often suggested that women are more often affected by TMD than men.
Many studies conducted so far indicate the existence of a strong relationship between TMD and psychosocial impairment including depression, somatization and anxiety. Patients with chronic pain condition have been found to exhibit high level of psychosocial impairments compared with painless controls . Many authors also indicate that the psychosocial factors reduce the response to the conservative treatment used among patients with TMD (occlusal splint therapy) and may increase the risk of the chronic form of this disorders.Therefore, the diagnosis of various types of psychosocial disorders among TMD patients is very important, because it will influence the appropriate clinical decisions and correct management protocol.
The available data on the relationship between TMD and psychosocial impairment contribute a lot to both the diagnosis and management of TMD. Unfortunately, the above data do not concern the prevalence and epidemiology of chronic pain, depression, anxiety and perceived stress in the polish population. Therefore, the data collected by the cited authors cannot be compared and the conclusions drawn from them cannot be used to the Polish population.
Based on these premises, the objectives of this study are to determine the level and prevalence of chronic pain, anxiety, depression and perceived stress among adult TMD patients from western Poland, and to use these data to identify and management of TMD.
A total of 219 adult patients from outpatient clinic for temporomandibular disorders participated in this retrospective study. All patients filled GCPS, GAD-7, PHQ-9 and PSS-10 questionnaires, and had TMD diagnosis based on DC/TMD examination carried out by an experienced dentist. After that statistical analysis was conducted.
- Conditions
- Temporomandibular Disorder, Depression, Anxiety, Pain, Stress
- Being tested
- DC/TMD examination
- Medical subject headings
- Temporomandibular Joint Disorders, Depression, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC/TMD examinationDiagnostic test
Clinical examination by examiners- experienced dentists (minimum 5 years of practice) and trained and calibrated in accordance with the protocol available on the official website of the International Network for Orofacial Pain and Related Disorders Methodology
| Study group | Role | What they receive |
|---|---|---|
| TMD group | Patients diagnosed with TMD Receives: Diagnostic Test: DC/TMD examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between TMD and pain assessed by Graded Chronic Pain Scale.
Each participant will fill in Graded Chronic Pain Scale. Scoring Criteria for Grading Chronic Pain Severity:
Characteristic Pain Intensity is a 0 to 100 score derived from Questions 1 through 3:Mean (Pain Right Now, Worst Pain, Average Pain) X 10. Disability Score is 0 to 100score derived from Questions 4 through 6:Mean (Daily Activities, Social Activities, Work Activities) X 10. Disability Points: Add the indicated points for Disability Days (Question 7)and for Disability Score. Classification: GRADE 0- No TMD pain in prior 6 months. GRADE I-Low Intensity Characteristic Pain Intensity<50, Low Disability<3 Disability Point. GRADE II -High Intensity Characteristic Pain Intensity >50, LowDisability<3 Disability Points. GRADE III- High Disability3 to 4 Disability Points, Moderately Limiting (Regardless of Characteristic Pain Intensity). GRADE IV- High Disability 5 to 6 Disability Points, Severely Limiting (Regardless of Characteristic Pain Intensity).
Measured: 1.12.2018-1.12.2021
Relationship between TMD and depression assessed by Patient Health Questionnaire - 9.
Each participant will fill in Patient Health Questionnaire - 9. PHQ-9 total score for the nine items ranges from 0 to 27.Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Measured: 1.12.2018-1.12.2021
Relationship between TMD and perceived stress assessed by Perceived Stress Scale - 10.
Each participant will fill in Perceived Stress Scale -10. Scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. It can range from 0 to 40. Scores ranging from 0-13 would be considered low stress,14-26 would be considered moderate stress, 27-40 would be considered high perceived stress.
Measured: 1.12.2018-1.12.2021
Relationship between TMD and anxiety assessed by Generalized Anxiety Disorder -7
Each participant will fill in Generalized Anxiety Disorder -7 that consists of 7 items. Total score ranges 0-21 points.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: 1.12.2018-1.12.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Nov 2018
- Primary completion1 Dec 2020
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Smardz, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183503
- Sponsor's protocol ID
- WMU3/2021
- Status last verified
- Jul 2026
- First submitted
- 20 Dec 2021
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wieckiewicz M, Jenca A Jr, Seweryn P, Orzeszek S, Petrasova A, Grychowska N, Winocur-Arias O, Emodi-Perlman A, Kujawa K. Determination of pain intensity, pain-related disability, anxiety, depression, and perceived stress in Polish adults with temporomandibular disorders: A prospective cohort study. Front Integr Neurosci. 2022 Nov 2;16:1026781. doi: 10.3389/fnint.2022.1026781. eCollection 2022.
PubMed 36407294
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Chronic Pain, Anxiety, Depression and Perceived Stress in Adults With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT05183503
- Acronym / sponsor ID
- WMU3/2021
- Conditions
- Temporomandibular Disorder, Depression, Anxiety, Pain, Stress
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jan 2022 (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.
The aim of the study was to asses levels and relationship of chronic pain, anxiety, depression and perceived stress in TMD patients .
Detailed description
Temporomandibular disorders (TMD) is an umbrella term describing a heterogenic group of conditions concerning masticatory muscles, temporomandibular joints and surrounding hard and soft structures. Most common signs and symptoms of TMD are: orofacial pain, joint sounds such as clicking or crepitus and limitation in jaw movements . Temporomandibular disorder (TMD) is the most common cause of orofacial pain and after chronic low back pain, it is the second cause of pain and disability in the musculoskeletal system. TMDs are considered as a global problem decreasing quality of life and potentially causing chronic pain, in daily activity limitation, anxiety, depression, general health problems, decreased work productivity and can lead to work absences.
The etiology of TMD is complex, multifactorial, and in many cases unclear. The biopsychosocial model tends to cover a broad spectrum of different conditions and aspects that may play a role in TMD occurrence. It integrates biological factors (structural disorders and disturbance in function) with psychosocial aspects (emotions, cognition, behaviors, reaction to stress and pain in context of family, workplace and community) .
The prevalence of TMD is estimated between 5-12% of the general population . About 26-30% of young adults present at least one symptom of TMD . The prevalence of TMD in adults over 45 years old is estimated between 2-7%.and in patients over 65 years old 3-5% . It is often suggested that women are more often affected by TMD than men.
Many studies conducted so far indicate the existence of a strong relationship between TMD and psychosocial impairment including depression, somatization and anxiety. Patients with chronic pain condition have been found to exhibit high level of psychosocial impairments compared with painless controls . Many authors also indicate that the psychosocial factors reduce the response to the conservative treatment used among patients with TMD (occlusal splint therapy) and may increase the risk of the chronic form of this disorders.Therefore, the diagnosis of various types of psychosocial disorders among TMD patients is very important, because it will influence the appropriate clinical decisions and correct management protocol.
The available data on the relationship between TMD and psychosocial impairment contribute a lot to both the diagnosis and management of TMD. Unfortunately, the above data do not concern the prevalence and epidemiology of chronic pain, depression, anxiety and perceived stress in the polish population. Therefore, the data collected by the cited authors cannot be compared and the conclusions drawn from them cannot be used to the Polish population.
Based on these premises, the objectives of this study are to determine the level and prevalence of chronic pain, anxiety, depression and perceived stress among adult TMD patients from western Poland, and to use these data to identify and management of TMD.
A total of 219 adult patients from outpatient clinic for temporomandibular disorders participated in this retrospective study. All patients filled GCPS, GAD-7, PHQ-9 and PSS-10 questionnaires, and had TMD diagnosis based on DC/TMD examination carried out by an experienced dentist. After that statistical analysis was conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMD group | – | Diagnostic Test: DC/TMD examinationPatients diagnosed with TMD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the Outpatient Clinic for Temporomandibular Disorders at the Medical University in Wroclaw diagnosed with TMD using Diagnostic Criteria for Temporomandibular Disorders (DC / TMD).
Key inclusion criteria (1 listed)
- Inclusion criteria for this study were age equal or above 18 years old and diagnosis of TMD based on DC/TMD examination form.
Key exclusion criteria (1 listed)
- The exclusion were severe neurological or mental diseases, taking medications that significantly affect the neuromuscular function, alcohol and/or drug addiction, active cancer diagnosis, pregnancy.
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 |
|---|---|---|
| DC/TMD examinationClinical examination by examiners- experienced dentists (minimum 5 years of practice) and trained and calibrated in accordance with the protocol available on the official website of the International Network for Orofacial Pain and Related Disorders Methodology | Diagnostic test | TMD group |
Primary outcome
Relationship between TMD and pain assessed by Graded Chronic Pain Scale.
Time frame: 1.12.2018-1.12.2021
Each participant will fill in Graded Chronic Pain Scale. Scoring Criteria for Grading Chronic Pain Severity: Characteristic Pain Intensity is a 0 to 100 score derived from Questions 1 through 3:Mean (Pain Right Now, Worst Pain, Average Pain) X 10. Disability Score is 0 to 100score derived from Questions 4 through 6:Mean (Daily Activities, Social Activities, Work Activities) X 10. Disability Points: Add the indicated points for Disability Days (Question 7)and for Disability Score. Classification: GRADE 0- No TMD pain in prior 6 months. GRADE I-Low Intensity Characteristic Pain Intensity<50, Low Disability<3 Disability Point. GRADE II -High Intensity Characteristic Pain Intensity >50, LowDisability<3 Disability Points. GRADE III- High Disability3 to 4 Disability Points, Moderately Limiting (Regardless of Characteristic Pain Intensity). GRADE IV- High Disability 5 to 6 Disability Points, Severely Limiting (Regardless of Characteristic Pain Intensity).
Relationship between TMD and depression assessed by Patient Health Questionnaire - 9.
Time frame: 1.12.2018-1.12.2021
Each participant will fill in Patient Health Questionnaire - 9. PHQ-9 total score for the nine items ranges from 0 to 27.Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Relationship between TMD and perceived stress assessed by Perceived Stress Scale - 10.
Time frame: 1.12.2018-1.12.2021
Each participant will fill in Perceived Stress Scale -10. Scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. It can range from 0 to 40. Scores ranging from 0-13 would be considered low stress,14-26 would be considered moderate stress, 27-40 would be considered high perceived stress.
Relationship between TMD and anxiety assessed by Generalized Anxiety Disorder -7
Time frame: 1.12.2018-1.12.2021
Each participant will fill in Generalized Anxiety Disorder -7 that consists of 7 items. Total score ranges 0-21 points. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Derived from this study: PubMed 36407294Wieckiewicz M, Jenca A Jr, Seweryn P, Orzeszek S, Petrasova A, Grychowska N, Winocur-Arias O, Emodi-Perlman A, Kujawa K. Determination of pain intensity, pain-related disability, anxiety, depression, and perceived stress in Polish adults with temporomandibular disorders: A prospective cohort study. Front Integr Neurosci. 2022 Nov 2;16:1026781. doi: 10.3389/fnint.2022.1026781. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Temporomandibular Disorder and Depression, run by Wroclaw Medical University at 1 site in Poland.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 10 Jul 2026. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Relationship between TMD and pain assessed by Graded Chronic Pain Scale. (time frame: 1.12.2018-1.12.2021). 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?
On the ClinicalTrials.gov record for NCT05183503, which also lists 1 linked publication.
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 10 Jul 2026.