Factors Affecting Patients With Myofascial Temporomandibular Disorders

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04842136
• Other study ID #: 2020/026
• Status: Completed
• Start date: January 13, 2020
• Est. completion date: February 25, 2021

Study information

• Verified date: April 2021
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 25, 2021
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bruxism
• Bruxism, Sleep
• Disease
• Dyssomnias
• Headache
• Jaw Spasm
• Myofascial Temporomandibular Disorder
• Parasomnias
• Sleep Bruxism
• Sleep Disturbance
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.

Locations

Country	Name	City	State
Turkey	Abdulkadir Konukoglu Healthy Life Center	Gaziantep
Turkey	Umut Rehabilitation Center	Sanliurfa

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Headache Impact Test	The Headache Impact Test-6 (HIT-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