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Factors Affecting Patients With Myofascial Temporomandibular Disorders

Comparison of Factors Affecting Patients With a Myofascial Temporomandibular Disorder With and Without Sleep Bruxism

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04842136
Enrollment
200
Registered
2021-04-13
Start date
2020-01-13
Completion date
2021-02-25
Last updated
2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism, Sleep, Headache, Jaw Spasm, Myofascial Temporomandibular Disorder, Sleep Disturbance

Keywords

Temporomandibular Disorders, Sleep bruxism, Neck Disability, Sleep, Headache

Brief 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).

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.

Interventions

OTHERScales and indexes

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.

Sponsors

Hasan Kalyoncu University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue ScaleBaselineThe 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 ScaleBaselineThe 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 IndexBaselineNeck 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 IndexBaselineThe 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 ScaleBaselineThe 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 TestBaselineThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026