Factors Affecting Patients With Myofascial Temporomandibular Disorders

NCT04842136 | Completed

• 1 other identifier: 2020/026
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Keywords

Temporomandibular Disorders; Sleep bruxism; Neck Disability; Sleep; Headache

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

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

Myofascial Temporomandibular Disorder (TMD) without Sleep Bruxism (SB)

Patients with Myofascial TMD without sleep bruxism were included in the group.

Other: Scales and indexes

Interventions

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.

Myofascial Temporomandibular Disorder (TMD) with Sleep Bruxism (SB); Myofascial Temporomandibular Disorder (TMD) without Sleep Bruxism (SB)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (2)

Abdulkadir Konukoglu Healthy Life Center

Gaziantep, Turkey (Türkiye)

Location

Umut Rehabilitation Center

Sanliurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Bruxism; Parasomnias; Tetanus; Headache; Temporomandibular Joint Disorders

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Aysenur Tuncer

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: January 13, 2020
• Primary Completion: December 18, 2020
• Study Completion: February 25, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)