Myofascial Temporomandibular DisorderNCT04842136
Factors Affecting Patients With Myofascial Temporomandibular Disorders
An observational study of Myofascial Temporomandibular Disorder and Bruxism, Sleep, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of the study was to assess and compare the relationship between jaw function, neck disability, sleep quality, fatigue, and headache in patients with myofascial Temporomandibular Disorder (TMD) with Sleep Bruxism (SB) and without (non-SB). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Temporomandibular Disorder, Bruxism, Sleep, Sleep Disturbance
- What is being tested?
- Scales and indexes
- How many people
- 200 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 13 Jan 2020to 25 Feb 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a chief complaint of pain and functional limitation at the temporomandibular region were assessed by dentists at regional hospitals. Those who were diagnosed with myofascial TMD according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) participated in the study.
Who may be able to join
- diagnosis of myofascial TMD according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- pain for more than 6 months
- no therapeutic interventions reported for TMD or the neck in the last 6 months
- intellectual capacity to provide informed consent
Who cannot join
- not meeting the DC/TMD criteria
- diagnosis of psychiatric disease
- history of surgery related to the cervical region and/or TMJ
- cervical and/or TMJ malignancy
- trauma history
- proven specific pathologies such as fracture, or rheumatoid disease
- history of facial paralysis
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Abdulkadir Konukoglu Healthy Life Center
Gaziantep
Umut Rehabilitation Center
Sanliurfa
About this study
Official title: Comparison of Factors Affecting Patients With a Myofascial Temporomandibular Disorder With and Without Sleep Bruxism
The aim of the study was to assess and compare the relationship between jaw function, neck disability, sleep quality, fatigue, and headache in patients with myofascial Temporomandibular Disorder (TMD) with Sleep Bruxism (SB) and without (non-SB).
Read the detailed description
The study was conducted on TMD patients who were willing to participate in the study between January and December 2020.
The case-control study included patients diagnosed with myofascial TMD by dental practitioners at regional hospitals referred for physiotherapy. Total of 200 myofascial TMD patients, comprising 91 identified as SB and 109 as non-SB were included in the study.
The Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales and indexes were used for both groups.
The effect of Sleep Bruxism (SB) on jaw function, neck problems, sleep quality, fatigue, and tension headache were evaluated.
The interactions of these factors and the importance of taking SB into consideration when evaluating and treating patients with TMD were examined.
- Conditions
- Myofascial Temporomandibular Disorder, Bruxism, Sleep, Sleep Disturbance, Jaw Spasm, Headache
- Being tested
- Scales and indexes
- Keywords
- Temporomandibular Disorders, Sleep bruxism, Neck Disability, Sleep, Headache
- Medical subject headings
- Sleep Bruxism, Parasomnias, Tetanus, Headache, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scales and indexesOther
Patients with TMD regardless of diagnosis with sleep bruxism were assessed with the Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Temporomandibular Disorder (TMD) with Sleep Bruxism (SB) | Patients with Myofascial TMD and with sleep bruxism with the diagnosis of regular or frequent teeth grinding sounds during the sleep, and one or more following clinical signs, such as jaw muscle pain or fatigue on waking up in the morning, temporal headache, hypertrophy of the masseter muscle, abnormal tooth wear, and/or jaw locking were included in the group. Receives: Other: Scales and indexes | |
| Myofascial Temporomandibular Disorder (TMD) without Sleep Bruxism (SB) | Patients with Myofascial TMD without sleep bruxism were included in the group. Receives: Other: Scales and indexes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The severity of pain in muscles was measured in centimeters using a 0-10 Visual Analogue Scales (VAS). The scale ranges from 0 = "no pain at all" to 10 = "intolerable pain"
Measured: Baseline
Jaw Functional Limitation Scale
The Jaw Functional Limitation Scale-20 was used to assess jaw function in the masticatory system. The scale consists of a total of 20 items with three constructs. Each item is scored from 0-10, with 0 indicating no restriction and 10, severe restriction. A total of ≥5 indicates jaw function limitation.
Measured: Baseline
Neck Disability Index
Neck problems were assessed with Neck Disability Index (NDI). It is a scale of 10 sections with total points ranging from 0-50. Higher scores indicate severe pain, and a score of ≥5 indicates a neck disorder.
Measured: Baseline
Pittsburgh Sleep Quality Index
The sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). The scale comprises a total of 24 items in 7 sub-scales. The total points of the 19 items that score from 0-21, with a total of ≥5 indicating poor sleep quality.
Measured: Baseline
Fatigue Severity Scale
The effect of fatigue on functional and behavioral aspects was evaluated by the Fatigue Severity Scale (FSS). The total score is calculated as the average of the 9 item scores -the lower the total score, the lower the fatigue level. A cut-off value of ≥4 has been defined for fatigue
Measured: Baseline
Headache Impact Test
The Headache Impact Test-6 (HİT-6) was used to assess the headache. The 6 items scale evaluating the frequency, the degree of restriction to daily life and social life, and changes in the mood because of headache. The total score 50-59 reflects important impact, and scores ≥60 indicate severe impact.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start13 Jan 2020
- Primary completion18 Dec 2020
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Tuncer, Hasan Kalyoncu University
- Investigators
- Aysenur Tuncer, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842136
- Sponsor's protocol ID
- 2020/026
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Factors Affecting Patients With a Myofascial Temporomandibular Disorder With and Without Sleep Bruxism
- ClinicalTrials.gov ID
- NCT04842136
- Acronym / sponsor ID
- 2020/026
- Conditions
- Myofascial Temporomandibular Disorder, Bruxism, Sleep, Sleep Disturbance, Jaw Spasm, Headache
- Keywords
- Temporomandibular Disorders, Sleep bruxism, Neck Disability, Sleep, Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 13 Apr 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.
The aim of the study was to assess and compare the relationship between jaw function, neck disability, sleep quality, fatigue, and headache in patients with myofascial Temporomandibular Disorder (TMD) with Sleep Bruxism (SB) and without (non-SB).
Detailed description
The study was conducted on TMD patients who were willing to participate in the study between January and December 2020.
The case-control study included patients diagnosed with myofascial TMD by dental practitioners at regional hospitals referred for physiotherapy. Total of 200 myofascial TMD patients, comprising 91 identified as SB and 109 as non-SB were included in the study.
The Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales and indexes were used for both groups.
The effect of Sleep Bruxism (SB) on jaw function, neck problems, sleep quality, fatigue, and tension headache were evaluated.
The interactions of these factors and the importance of taking SB into consideration when evaluating and treating patients with TMD were examined.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial Temporomandibular Disorder (TMD) with Sleep Bruxism (SB) | – | Other: Scales and indexesPatients with Myofascial TMD and with sleep bruxism with the diagnosis of regular or frequent teeth grinding sounds during the sleep, and one or more following clinical signs, such as jaw muscle pain or fatigue on waking up in the morning, temporal headache, hypertrophy of the masseter muscle, abnormal tooth wear, and/or jaw locking were included in the group. |
| Myofascial Temporomandibular Disorder (TMD) without Sleep Bruxism (SB) | – | Other: Scales and indexesPatients with Myofascial TMD without sleep bruxism were included in the group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a chief complaint of pain and functional limitation at the temporomandibular region were assessed by dentists at regional hospitals. Those who were diagnosed with myofascial TMD according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) participated in the study.
Key inclusion criteria (4 listed)
- diagnosis of myofascial TMD according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- pain for more than 6 months
- no therapeutic interventions reported for TMD or the neck in the last 6 months
- intellectual capacity to provide informed consent
Key exclusion criteria (8 listed)
- not meeting the DC/TMD criteria
- diagnosis of psychiatric disease
- history of surgery related to the cervical region and/or TMJ
- cervical and/or TMJ malignancy
- trauma history
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 |
|---|---|---|
| Scales and indexesPatients with TMD regardless of diagnosis with sleep bruxism were assessed with the Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales. | Other | Myofascial Temporomandibular Disorder (TMD) with Sleep Bruxism (SB), Myofascial Temporomandibular Disorder (TMD) without Sleep Bruxism (SB) |
Primary outcome
Visual Analogue Scale
Time frame: Baseline
The severity of pain in muscles was measured in centimeters using a 0-10 Visual Analogue Scales (VAS). The scale ranges from 0 = "no pain at all" to 10 = "intolerable pain"
Jaw Functional Limitation Scale
Time frame: Baseline
The Jaw Functional Limitation Scale-20 was used to assess jaw function in the masticatory system. The scale consists of a total of 20 items with three constructs. Each item is scored from 0-10, with 0 indicating no restriction and 10, severe restriction. A total of ≥5 indicates jaw function limitation.
Neck Disability Index
Time frame: Baseline
Neck problems were assessed with Neck Disability Index (NDI). It is a scale of 10 sections with total points ranging from 0-50. Higher scores indicate severe pain, and a score of ≥5 indicates a neck disorder.
Pittsburgh Sleep Quality Index
Time frame: Baseline
The sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). The scale comprises a total of 24 items in 7 sub-scales. The total points of the 19 items that score from 0-21, with a total of ≥5 indicating poor sleep quality.
Fatigue Severity Scale
Time frame: Baseline
The effect of fatigue on functional and behavioral aspects was evaluated by the Fatigue Severity Scale (FSS). The total score is calculated as the average of the 9 item scores -the lower the total score, the lower the fatigue level. A cut-off value of ≥4 has been defined for fatigue
Headache Impact Test
Time frame: Baseline
The Headache Impact Test-6 (HİT-6) was used to assess the headache. The 6 items scale evaluating the frequency, the degree of restriction to daily life and social life, and changes in the mood because of headache. The total score 50-59 reflects important impact, and scores ≥60 indicate severe impact.
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 13 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Myofascial Temporomandibular Disorder
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
RecruitingObservational study
Masticatory Muscle Activity Using a 24-Hour Wearable Device
Chronic Masticatory Myofascial Pain
RecruitingPhase 2
Clinical Evaluation of Botulinum Toxin a in the Management of Temporomandibular Myofascial Pain
Temporomandibular Disorder
Recruiting
Temporomandibular Joint (TMJ) Positioning Accuracy and Efficiency Using a Dental Compass.
Temporomandibular Joint Syndrome
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.
Aysenur Tuncer study director
Hasan Kalyoncu University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myofascial Temporomandibular Disorder and Bruxism, Sleep, run by Hasan Kalyoncu University at 2 sites 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 4 inclusion and 8 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 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Visual Analogue Scale (time frame: Baseline). The study lists 6 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 13 Apr 2021.