Clinical trial NCT04842136: Factors Affecting Patients With Myofascial Temporomandibular Disorders
Official title: Comparison of Factors Affecting Patients With a Myofascial Temporomandibular Disorder With and Without Sleep Bruxism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myofascial Temporomandibular Disorder
Bruxism, Sleep
Sleep Disturbance
Jaw Spasm
Headache
Keywords: Temporomandibular Disorders
Sleep bruxism
Neck Disability
Sleep
Headache
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Baseline
measure: Jaw Functional Limitation Scale
timeFrame: Baseline
measure: Neck Disability Index
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Fatigue Severity Scale
timeFrame: Baseline
measure: Headache Impact Test
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Abdulkadir Konukoglu Healthy Life Center
city: Şanlıurfa
country: Turkey
facility: Umut Rehabilitation Center
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur Tuncer
role: STUDY_DIRECTOR
References: