Temporomandibular Disorders (TMD)NCT06722833
Physiotherapy Investigation in Patient With Temporomandibular Joint Dysfunction
An observational study of Temporomandibular Disorders (TMD), run by Uskudar University.
Trial summary
Knowing the associated factors for people suffering from TMD may help to develop preventive, therapeutic and health strategies. The aim of this study was to present the assessments of audiovestibular symptoms in people with TMD. The main question it aims to answer is the questions are as follows: 1. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 1 May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
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 35 years
- All sexes
- Adult
Study population: Young adults diagnosed with TMD
Who may be able to join
- Volunteer to participate in the study between the ages of 18-35
- Diagnosed with unilateral TMJ disorder at least 1 month ago according to the - Research Diagnostic Criteria of Temporomandibular Disorders (RDC/TMD) classification (Dworkin et al., 1992)
- Having muscle tenderness and pain in the temporomandibular joint region
Who cannot join
- Traumatic injuries in the same area other than TMD
- Ear diseases that cause hearing loss
- Dentofacial Anomalies
- Receiving orthodontic treatment
- Neurological diseases, vestibular or visual problems
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of Pain, Function and Audiovestibular System Features in Individuals With Temporomandibular Joint Dysfunction
Knowing the associated factors for people suffering from TMD may help to develop preventive, therapeutic and health strategies. The aim of this study was to present the assessments of audiovestibular symptoms in people with TMD. The main question it aims to answer is the questions are as follows:
- Is there a relationship between TMJ symptoms and audiovestibular assessment in people with TMD?
Participants will:
Participants diagnosed with TMD will be informed about the study and informed consent will be obtained. Data obtained after the TMJ and vestibular system evaluation of the participants will be analyzed.
Read the detailed description
Temporomandibular dysfunction (TMD) is a health condition affecting the temporomandibular joint (TMJ) and related structures. The prevalence of TMD in adults affects a very large portion of the world's population. TMD is complex and multifactorial due to its etiology with neuromuscular, traumatic, degenerative and sociodemographic aspects. The aim of this study is to reveal audiovestibular assessments in individuals with TMD. After obtaining voluntary consent forms, participants are subjected to assessments. The "Statistical Package for Social Sciences (SPSS) Statistics 23.0 (SPSS Inc, Chicago, USA) program will be used in the analysis of the study data. Before starting the analysis of the data, the Kolmogorv Smirnov test will be used to check whether the data is suitable for normal distribution. Data that are suitable for normal distribution will be analyzed with parametric tests, and those that are not suitable for normal distribution will be analyzed with non-parametric tests. Descriptive statistics for quantitative variables will be shown as mean and standard deviation, and for qualitative variables determined by counting, descriptive statistics will be shown as numbers and percentages. T-test/chi square/Mann Whitney U will be used in two-group comparisons, and one-way variance analysis/Kruskal Wallis test will be used in three-group comparisons.
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- temporomandibular dysfunction, pain
- Medical subject headings
- Temporomandibular Joint Disorders, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual analog scale (VAS) will be used to assess the pain intensity of individuals related to TMJD. The individual will be asked to mark the perceived pain intensity on a 10 cm long horizontal line. The individual's pain intensity will be recorded by measuring the distance the individual marks on the line in millimeters.
Measured: 1 day (The evaluation will be done one-time)
Evaluation of Temporomandibular Joint Functional Status
Mandibular Dysfunction Questionnaire (MFBA) was administered to individuals to assess the functional status of the joint and the level of functional impairment that its dysfunction may cause.
Measured: 1 day (The evaluation will be done one-time)
Secondary outcomes (2)
Measurement of Temporomandibular Joint Mobility
Individuals will be instructed to open their mouths as wide as possible without causing pain and joint mobility will be measured and recorded using a millimetric ruler. TMJ movements in all directions will be measured three times and the average of the measurements will be recorded and noted.
Measured: 1 day (The evaluation will be done one-time)
Immittancemetric Evaluation
Before tympanometric evaluation, otoscopic examination is performed. Tympanometry, acoustic reflex and eustachian tube function tests are performed with the Interacoustics® Titan Handheld (Denmark) device.
Measured: 1 day (The evaluation will be done one-time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start30 Dec 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FİLİZ EYÜBOĞLU, Uskudar University
- Investigators
- Filiz Eyüboğlu, PhD, Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722833
- Sponsor's protocol ID
- tmjstudy1
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No