Prevalence of Temporomandibular Joint Dysfunction in Patients With Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05839925
• Other study ID #: IstanbulPRMTRH
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2024
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: April 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Joint Diseases
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Diagnostic Test:
• Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I and II
The presence of temporomandibular joint dysfunction was evaluated using the diagnostic criteria for temporomandibular disorders (DC/TMD).

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine Rehabilitation Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Bilgin E, Bilgin E, Ozdemir O, Kalyoncu U. Temporomandibular disorders in ankylosing spondylitis: a cross-sectional, monocentric study. Rheumatol Int. 2020 Jun;40(6):933-940. doi: 10.1007/s00296-020-04563-y. Epub 2020 Apr 1. — View Citation

Braun J, Sieper J. Ankylosing spondylitis. Lancet. 2007 Apr 21;369(9570):1379-1390. doi: 10.1016/S0140-6736(07)60635-7. — View Citation

Huang YF, Chang CT, Muo CH, Chiu KM, Tsai CH, Liu SP. Bidirectional relationship between temporomandibular disorder and ankylosing spondylitis: a population-based cohort study. Clin Oral Investig. 2021 Nov;25(11):6377-6384. doi: 10.1007/s00784-021-03938-0. Epub 2021 Apr 14. — View Citation

Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17. Erratum In: Ann Rheum Dis. 2019 Jun;78(6):e59. — View Citation

Souza RC, de Sousa ET, Sousa D, Sales M, Dos Santos Oliveira R, Mariano MH, Rushansky E, Amorim Gomes AC, Silva E. Prevalence of Temporomandibular Joint Disorders in Patients with Ankylosing Spondylitis: A Cross-Sectional Study. Clin Cosmet Investig Dent. 2021 Nov 11;13:469-478. doi: 10.2147/CCIDE.S320537. eCollection 2021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I Symptom questionnaire	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.	A single point in time (1 day)
Primary	Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I Clinical Examination Form questionnaire	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.	A single point in time (1 day)
Secondary	The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to assess the disease activity.	A single point in time (1 day)
Secondary	Bath Ankylosing Spondylitis Functional Index (BASFI)	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.	A single point in time (1 day)
Secondary	The Bath Ankylosing Spondylitis Metrology Index (BASMI)	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.	A single point in time (1 day)
Secondary	DC/TMD Axis II-Pain Drawing questionnaire	Pain Drawing which assesses pain location and spread.	A single point in time (1 day)
Secondary	DC/TMD Axis II-Patient Health Questionnaire-9 (PHQ-9)	Patient Health Questionnaire-9 (PHQ-9), which assesses depressed mood state.	A single point in time (1 day)
Secondary	DC/TMD Axis II- Oral Behaviors Checklist (OBC)	Oral Behaviors Checklist (OBC), which assesses parafunctional behaviors	A single point in time (1 day)
Secondary	DC/TMD Axis II-Jaw Functional Limitation Scale-20 (JFLS-20)	Jaw Functional Limitation Scale-20 (JFLS-20) , which assesses limitation of mastication, mobility and verbal end emotional expressions.	A single point in time (1 day)
Secondary	DC/TMD Axis II-Patient Health Questionnaire-15 (PHQ-15)	Patient Health Questionnaire-15, which assesses non-specific physical symptoms	A single point in time (1 day)
Secondary	DC/TMD Axis II-Graded Chronic Pain Scale; GCPS v2.0	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.	A single point in time (1 day)
Secondary	DC/TMD Axis II- General Anxiety Disorder 7 (GAD-7)	The General Anxiety Disorder 7 (GAD-7) is a brief self-report questionnaire that is used to assess the severity of generalized anxiety disorder	A single point in time (1 day)