Factors Affecting Patients With Myofascial Temporomandibular Disorders

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).

Study Overview

• Status: Completed
• Conditions: Sleep Disturbance; Headache; Bruxism, Sleep; Myofascial Temporomandibular Disorder; Jaw Spasm
• Intervention / Treatment: Other: Scales and indexes

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Turkey
  • Gaziantep, Turkey
    • Abdulkadir Konukoglu Healthy Life Center
  • Şanlıurfa, Turkey
    • Umut Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Scales 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.
Myofascial Temporomandibular Disorder (TMD) without Sleep Bruxism (SB); Patients with Myofascial TMD without sleep bruxism were included in the group.	Other: Scales 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	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.	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.	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.	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	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.	Baseline

Collaborators and Investigators

• Sponsor: Hasan Kalyoncu University
• Investigators: Study Director: Aysenur Tuncer, Hasan Kalyoncu University

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): February 25, 2021

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Headache; Sleep; Temporomandibular Disorders; Neck Disability; Sleep bruxism
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Wake Disorders; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Tooth Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Disease; Dyssomnias; Parasomnias; Headache; Bruxism; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Sleep Bruxism
• Other Study ID Numbers: 2020/026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No