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Temporomandibular DisorderNCT04867044

Prevalence of Temporomandibular Disorders in Patients With Fibromyalgia Syndrome

An observational study of Temporomandibular Disorder and Fibromyalgia, run by Yerkoy State Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 150 healthy woman volunteers will be included.Demographic data (age, gender, height, weight, marital status, education level) and duration of fibromyalgia diagnosis will be… Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Temporomandibular Disorder, Fibromyalgia
What is being tested?
STUDY
How many people
300 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 May 2021to 27 Aug 2021
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Our study consists of 300 female participants aged between 18 and 65 years who applied to the physical therapy and rehabilitation outpatient clinic.. One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 150 healthy woman volunteers were included.Because fibromyalgia is a disease that mostly affects women, we designed our study so that all participants were women.

Who may be able to join

  • One hundred fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria
  • One hundred fifty womanhealthy volunteers

Who cannot join

  • Patients with temporomandibular region surgery
  • Congenital teporomandibular joint pathologies
  • Previous temporomandibular region trauma were excluded from the study.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Basak Cigdem karacay

    Yozgat, Yerkoy, 66900

  • Basak CigdemKaracay

    Yozgat, Yerkoy, 66900

Other trials in Turkey (Türkiye)

About this study

One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 150 healthy woman volunteers will be included.Demographic data (age, gender, height, weight, marital status, education level) and duration of fibromyalgia diagnosis will be recorded. Patients will be evaluated according to the Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments (DCTMD: AI ). Patients will be evaluated by Diagnostic Criteria for Temporomandibular Disorders: Temporomandibular Disorders (TMD) Pain Screener, Symptom questionnaire, Clinical Examination Form from Assessment Instruments Axis I. Pain Drawing, Graded Chronic Pain (version 2), Jaw Functional Limitation Scale-8 (JFLS-8), Patient Health Questionnaire (PHQ-4), Oral Behaviors Checklist will be applied within the scope of Axis II.

Read the detailed description

In our study, the investigators aim to compare the frequency of temporomandibular disorders between healthy female participants and female patients diagnosed with fibromyalgia.

Our study will consists of 300 female participants aged between 18 and 65 years who applied to the physical therapy and rehabilitation outpatient clinic between May 2021 and August 2021. This case-control study will conducted according to the Declaration of Helsinki. Participants gave written voluntary consent and enrolled in this case-control study. One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 150 healthy woman volunteers will be included. Patients with temporomandibular region surgery, congenital teporomandibular joint pathologies, and previous temporomandibular region trauma were will be excluded from the study. Because fibromyalgia is a disease that mostly affects women, the investigators designed our study so that all participants were women. In addition, demographic data (age, gender, height, weight, marital status, education level) and duration of fibromyalgia diagnosis will be recorded. Patients will be evaluated according to the Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments ( DCTMD: AI ). Patients will be evaluated by Diagnostic Criteria for Temporomandibular Disorders: TMD Pain Screener, Symptom questionnaire, Clinical Examination Form from Assessment Instruments Axis I. Pain Drawing, Graded Chronic Pain (version 2), Jaw Functional Limitation Scale-8 (JFLS-8), Patient Health Questionnaire (PHQ-4),Oral Behaviors Checklist will be applied within the scope of Axis II.

Being tested
STUDY, Control
Keywords
fibromiyalgia syndrome, Temporomandibular Disorders
Medical subject headings
Temporomandibular Joint Disorders, Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STUDYOther

    Also called Fibromiyalgia Patient

    One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria

  • ControlOther

    Also called healthy participant

    healthy woman volunteers

Study groups in NCT04867044
Study groupRoleWhat they receive
STUDY GROUPpatient diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria
Receives: Other: STUDY
CONTROL GROUPhealthy women volunteers
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DCTMD: AI Axis I Pain Screener

    TMD Pain Screener which is a simple, reliable, and valid self-report instrument used to assess for the presence of any pain-related TMD, with sensitivity and specificity ≥ 0.95 which is recommended for all patients in any clinical setting. A positive screen is followed by further evaluation to arrive at the specific TMD pain-related diagnoses.

    Measured: 0 DAY

  2. DCTMD: AI Axis I Symptom questionnaire

    Symptom questionnaire which assess pain characteristics as well as history of jaw noise, jaw locking, and headache.

    Measured: 0 DAY

  3. DCTMD: AI Axis I Clinical Examination Form

    Clinical Examination Form- The clinical examination includes provocation tests for TMJ arthralgia of pain with any jaw movement (ie, opening, lateral, and protrusive) and TMJ palpation. For myalgia, the tests include pain with opening jaw movements and palpation of the temporalis and masseter muscles.

    Measured: 0 DAY

Secondary outcomes (5)

  1. DCTMD: AI Axis II-Pain Drawing

    Pain Drawing-pain drawing of the head, jaw, and body, and it allows the patient to report the location of all pain complaints

    Measured: 0 DAY

  2. DCTMD: AI Axis II-Graded Chronic Pain (version 2)

    Graded Chronic Pain (version 2) is a short, reliable, and valid instrument that assesses pain intensity and pain-related disability.10 The two GCPS subscales are: Characteristic Pain Intensity (CPI), which reliably measures pain intensity, with ≥ 50/100 considered "high intensity," and the pain-disability rating, which is based on number of days that pain interferes with activity and on extent of interference with social, work, or usual daily activities

    Measured: 0 DAY

  3. DCTMD: AI Axis II-Jaw Functional Limitation Scale-8 (JFLS-8)

    Jaw Functional Limitation Scale-8 (JFLS-8) which assesses global limitations across mastication, jaw mobility, and verbal and emotional expression

    Measured: 0 DAY

  4. DCTMD: AI Axis II-Patient Health Questionnaire (PHQ-4)

    Patient Health Questionnaire (PHQ-4) is a short, reliable, and valid screening instrument for detecting "psychological distress" due to anxiety and/or depression in patients in any clinical setting.A cutoff of > 6, suggesting moderate psychological stress, should be interpreted as warranting observation, while a cutoff of > 9, suggesting severe psychological distress, should be interpreted as warranting either further assessment or referral

    Measured: 0 DAY

  5. DCTMD: AI Axis II- Oral Behaviors Checklist (OBC)

    Oral Behaviors Checklist (OBC), which assesses the frequency of oral parafunctional behaviors.

    Measured: 0 DAY

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2021
  2. Study start1 May 2021
  3. Primary completion1 Jun 2021
  4. Study completion27 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
300 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT04867044
Sponsor's protocol ID
2017-KAEK-189_2021.03.10_17
Status last verified
Jul 2022
First submitted
22 Apr 2021
Last updated
13 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Moreno-Fernandez AM, Jimenez-Castellanos E, Iglesias-Linares A, Bueso-Madrid D, Fernandez-Rodriguez A, de Miguel M. Fibromyalgia syndrome and temporomandibular disorders with muscular pain. A review. Mod Rheumatol. 2017 Mar;27(2):210-216. doi: 10.1080/14397595.2016.1221788. Epub 2017 Feb 1.

    PubMed 27539739

  • Fujarra FJ, Kaziyama HH, Siqueira SR, Yeng LT, Camparis CM, Teixeira MJ, Siqueira JT. Temporomandibular disorders in fibromyalgia patients: are there different pain onset? Arq Neuropsiquiatr. 2016 Mar;74(3):195-200. doi: 10.1590/0004-282X20160017.

    PubMed 27050847

  • Pimentel MJ, Gui MS, Martins de Aquino LM, Rizzatti-Barbosa CM. Features of temporomandibular disorders in fibromyalgia syndrome. Cranio. 2013 Jan;31(1):40-5. doi: 10.1179/crn.2013.006.

    PubMed 23461261

Questions about this trial

What is this clinical trial studying?

An observational study of Temporomandibular Disorder and Fibromyalgia, run by Yerkoy State Hospital at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DCTMD: AI Axis I Pain Screener (time frame: 0 DAY). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04867044, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.

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