Skip to main content
OpenTrials
Completed

NCT Number: NCT05839925

Prevalence of Temporomandibular Joint Dysfunction in Patients With Ankylosing Spondylitis

This study included 113 patients diagnosed with ankylosing spondylitis and 110 healthy volunteers. Participants in both groups were evaluated using the 'Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)' diagnostic criteria. In addition, the relationship between temporomandibular joint dysfunction and disease activity was investigated in patients with ankylosing spondylitis.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

Ankylosing spondylitis (AS) is a chronic, inflammatory disease with an unknown etiology that primarily affects the axial spine, especially the sacroiliac joints, and can also involve peripheral joints and extra-articular clinical manifestations. Complaints related to temporomandibular joint pathologies are commonly observed in the general population but more frequent in the group of patients diagnosed with ankylosing spondylitis compared to the average population. Although the mechanism of temporomandibular joint involvement in ankylosing spondylitis is not fully understood, destruction of the joint capsule or disk, synovitis in the joint, and craniovertebral postural changes have been suggested as possible mechanisms. In addition, pain due to temporomandibular joint dysfunction can significantly affect daily life activities, quality of life, social participation, and the emotional status of the individual. Determining the level of relationship between quality of life and psychological status will support the development of new interventions and treatment approaches to improve patient's quality of life further.

The age, gender, body mass index, marital status, duration of ankylosing spondylitis (AS) diagnosis, symptom onset, treatment for AS, occupation, smoking status, and Human Leukocyte Antigen (HLA)-B27 positivity status were recorded for the patient. The 'Diagnostic Criteria for Temporomandibular Disorders (DC/TMD),' published in 2014 and translated into Turkish in 2016, was used to assess the presence of temporomandibular joint dysfunction in the patients. This evaluation system consists of two parts: the clinical evaluation and examination findings of the current pathology on Axis I, and the psychosocial status of the disease on Axis II. The questions in the Symptom Questionnaire on the first axis were directed to the patient, and then the results were recorded by performing the examinations indicated on the examination form. The diagnosis was determined according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) decision tree, and marked on the examination form. Two groups were created based on the decision tree: pain and joint disorders. Pain disorders were further subdivided into muscle pain, joint pain, and TMD-related headaches; muscle pain was further subdivided into local muscle pain, muscle-fascial pain, and referred muscle-fascial pain subgroups. Joint disorders were classified as disc displacement with reduction, disc displacement with reduction-intermittent locking, disc displacement without reduction-limited mouth opening, disc displacement without reduction-limited mouth opening, degenerative joint disease, and dislocation.

On Axis II, the patients were asked to mark the areas where they felt pain on the pain drawing form. The marked area was divided into categories according to its size. The level of experienced pain was evaluated with the Graded Chronic Pain Scale (GCPS), jaw function limitations were assessed with the Jaw Functional Limitation Scale-20 (JFLS-20), depression was evaluated with the Patient Health Questionnaire-9 (PHQ-9), anxiety was assessed with the General Anxiety Disorder 7 (GAD-7), physical symptoms were evaluated with the Patient Health Questionnaire-15 (PHQ-15), and parafunctional activities were evaluated with the Oral Behavior Checklist (OBC). Additionally, the relationship between the identified diagnosis and psychosocial factors, disease activity, and other disease-specific factors was investigated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria between the ages of 18-75.
  • Healthy volunteers between the ages of 18 and 75.

Exclusion criteria

  • Changes in the treatment of ankylosing spondylitis within the last 6 months
  • Patients with pathology related to the temporomandibular joint and associated structures prior to the diagnosis of ankylosing spondylitis
  • Use of medication that affects bone metabolism
  • Presence of neurological or cognitive deficits
  • History of trauma, malignancy, infection, and surgery in the head and neck area
  • Presence of dental or periodontal pain
  • History of orthodontic treatment.

Treatment and study plan

Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I and II

Diagnostic Test

The presence of temporomandibular joint dysfunction was evaluated using the diagnostic criteria for temporomandibular disorders (DC/TMD).

Primary outcomes

  1. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I Symptom questionnaire

    Time frame: A single point in time (1 day)

    The presence of temporomandibular joint dysfunction will be evaluated using the The questionnaire that investigates temporomandibular region pain and characteristics, joint sounds, and headache was used.

  2. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I Clinical Examination Form questionnaire

    Time frame: A single point in time (1 day)

    Clinical Examination form assesses the site of pain, incisal relationships, mouth opening position, mouth opening and closing movements, lateral and protrusive movements, jaw noise, joint locking, and evaluation of muscle and joint pain by palpation.

Secondary outcomes

  1. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: A single point in time (1 day)

    The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to assess the disease activity.

  2. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: A single point in time (1 day)

    Bath Ankylosing Spondylitis Functional Index (BASFI) is a tool used to assess the functional ability of patients with ankylosing spondylitis. It includes questions about the patient's ability to perform daily activities such as dressing, grooming, standing, and bending.

  3. The Bath Ankylosing Spondylitis Metrology Index (BASMI)

    Time frame: A single point in time (1 day)

    The Bath Ankylosing Spondylitis Metrology Index (BASMI) was used to assess spinal mobility. The Bath Ankylosing Spondylitis Metrology Index (BASMI) includes measurements of tragus-to-wall distance, intermalleolar distance, modified Schober's test, lateral flexion, and cervical rotation.

  4. DC/TMD Axis II-Pain Drawing questionnaire

    Time frame: A single point in time (1 day)

    Pain Drawing which assesses pain location and spread.

  5. DC/TMD Axis II-Patient Health Questionnaire-9 (PHQ-9)

    Time frame: A single point in time (1 day)

    Patient Health Questionnaire-9 (PHQ-9), which assesses depressed mood state.

  6. DC/TMD Axis II- Oral Behaviors Checklist (OBC)

    Time frame: A single point in time (1 day)

    Oral Behaviors Checklist (OBC), which assesses parafunctional behaviors

  7. DC/TMD Axis II-Jaw Functional Limitation Scale-20 (JFLS-20)

    Time frame: A single point in time (1 day)

    Jaw Functional Limitation Scale-20 (JFLS-20) , which assesses limitation of mastication, mobility and verbal end emotional expressions.

  8. DC/TMD Axis II-Patient Health Questionnaire-15 (PHQ-15)

    Time frame: A single point in time (1 day)

    Patient Health Questionnaire-15, which assesses non-specific physical symptoms

  9. DC/TMD Axis II-Graded Chronic Pain Scale; GCPS v2.0

    Time frame: A single point in time (1 day)

    Graded Chronic Pain Scale (GCPS) is a tool used to assess the severity and impact of chronic pain on a person's life. It involves rating the intensity of pain, as well as how much pain interferes with daily activities and quality of life.

  10. DC/TMD Axis II- General Anxiety Disorder 7 (GAD-7)

    Time frame: A single point in time (1 day)

    The General Anxiety Disorder 7 (GAD-7) is a brief self-report questionnaire that is used to assess the severity of generalized anxiety disorder

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

Prevalence of Temporomandibular Joint Dysfunction in Patients With Ankylosing Spondylitis and Comparison of the Findings With Healthy Controls

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 3, 2023
Registry last updated
Feb 20, 2024

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.

Published trials that share one or more normalized conditions with this study.