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Completed

NCT Number: NCT04842136

Factors Affecting Patients With Myofascial Temporomandibular Disorders

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).

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Key information

Conditions

Myofascial Temporomandibular Disorder Bacterial Infections Bacterial Infections and Mycoses Bruxism Bruxism, Sleep Clostridium Infections Craniomandibular Disorders Gram-Positive Bacterial Infections Headache Infections Jaw Diseases Jaw Spasm Joint Diseases Mandibular Diseases Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Bruxism Sleep Disturbance Sleep Wake Disorders Stomatognathic Diseases Temporomandibular Joint Disorders Tetanus Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Abdulkadir Konukoglu Healthy Life Center, Gaziantep, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scales and indexes

Other

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.

Primary outcomes

  1. 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"

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 13, 2021
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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