NCT05839925

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

April 21, 2023

Last Update Submit

February 18, 2024

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing SpondylitisTemporomandibular Joint DisordersTemporomandibular DisordersTMJSpondyloarthropathy

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (10)

  • The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    A single point in time (1 day)

  • Bath Ankylosing Spondylitis Functional Index (BASFI)

    A single point in time (1 day)

  • The Bath Ankylosing Spondylitis Metrology Index (BASMI)

    A single point in time (1 day)

  • DC/TMD Axis II-Pain Drawing questionnaire

    A single point in time (1 day)

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

    A single point in time (1 day)

  • +5 more secondary outcomes

Study Arms (2)

Ankylosing spondylitis group

The patients were selected on a randomized form among the patients with a diagnosis of AS according to the modified New York criteria who referred to Istanbul Physical Medicine Rehabilitation Training and Research Hospital.

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

Healthy volunteers

Healthy volunteers between the ages of 18-75 were selected randomly.

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

Interventions

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

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

Ankylosing spondylitis groupHealthy volunteers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

113 patients with ankylosing spondylitis were diagnosed and 110 healthy volunteers.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 32239320BACKGROUND

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

    PMID: 17448825BACKGROUND

  • 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.

    PMID: 33855657BACKGROUND

  • 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.

    PMID: 19297344BACKGROUND

  • 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.

    PMID: 34795532BACKGROUND

  • Ahisha BS, Kesiktas FN. Prevalence of temporomandibular joint dysfunction in patients with ankylosing spondylitis and comparison of the findings with healthy controls. Rev Assoc Med Bras (1992). 2024 Sep 30;70(10):e20240807. doi: 10.1590/1806-9282.20240807. eCollection 2024.

    PMID: 39356963DERIVED

MeSH Terms

Conditions

Spondylitis, AnkylosingTemporomandibular Joint DisordersSpondylarthropathies

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisCraniomandibular DisordersMandibular DiseasesJaw DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Fatma Nur Kesiktaş, Prof

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 3, 2023

Study Start

April 1, 2022

Primary Completion

July 1, 2022

Study Completion

April 1, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

TU(1)