Temporomandibular Joint DisordersNCT04780711
Prevalance of Temporomandibular Joint Disease
An observational study of Temporomandibular Joint Disorders, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Temporomandibular joint (TMJ) disorders are common problems in the society and involve the masticator muscles, jaw joint and related structures. Since TMJ disorders affect functions such as eating and speaking, they can cause important problems in the daily life of the patient. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2021to 1 Aug 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We planned to include 500 volunteer students between the ages of 18-35, studying at Bolu Abant Izzet Baysal University Faculty of Medicine, with or without TMJ symptoms and agreeing to participate in the study.
Who may be able to join
- Being a medical student
- Being between the ages of 18-35
Who cannot join
- Students who do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalance of Temporomandibular Joint Disease in Medical School Students
Temporomandibular joint (TMJ) disorders are common problems in the society and involve the masticator muscles, jaw joint and related structures. Since TMJ disorders affect functions such as eating and speaking, they can cause important problems in the daily life of the patient. Therefore, its diagnosis and treatment are of great importance. In the treatment of these patients, methods such as analgesic and anti-inflammatory drugs, splint, exercise, physical therapy modalities can be applied.
Read the detailed description
Although the prevalence of TMJ disease detected in the community is between 40-60%, the rate of symptoms or clinical findings was reported to be 87% in a study including 1040 people. Incomplete clarification of the etiology and pathogenesis, the lack of standard diagnostic and treatment approaches cause patients to learn to live with this problem, and severe pain and limitation of movement cause a decrease in quality of life and loss of workforce. Specific pathologies such as systemic inflammatory diseases, tumor, fracture, developmental anomaly cause temporomandibular joint diseases. It also causes a wider group of non-specific TMB originating from the musculoskeletal system.When the literature was reviewed, no publications on the frequency of TMJ joint disease were found in medical faculty students.
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Temporomandibular Joint Disorders
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Group | Demographic data, symptoms for TMJ of the students will be recorded. Physical examination will be included range of motion of temporomandibular joint, right and left TMJ lateral range of motion, whether there is a gradual opening, during deflection and deviation during the opening and subluxation for palpation and measurements. Opening and closing clicks, crepitation and popping will be recorded during palpation. Deep palpation of the skin, masseter and temporal muscles will be determined, posture analysis will be recorded and dental interventions, missing teeth, orthodontic treatments and bruxism histories will be taken. An appropriate diagnosis will be determined for students who are found to have pathology as a result of all these examinations and information about this diagnosis will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouth opening
The patient opens her mouth to the maximum, the lower border of the anterior upper teeth and the distance to the upper border of the lower teeth are measured.
Measured: Baseline
Tenderness in the masseter and temporal muscles on deep palpation
Tenderness in the masseter and temporal muscles on deep palpation
Measured: Baseline
Click in the temporomandibular joint
The patient's temporomandibular joint is palpated, and it is checked whether there is click or popping when opening or closing the mouth.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start20 Mar 2021
- Primary completion28 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif yaksi, Abant Izzet Baysal University
- Investigators
- Elif Yakşi, MD, Principal investigator, Abant İzzet Baysal University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780711
- Sponsor's protocol ID
- AIBU-FTR-EY-01
- Status last verified
- Aug 2021
- First submitted
- 21 Feb 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalance of Temporomandibular Joint Disease in Medical School Students
- ClinicalTrials.gov ID
- NCT04780711
- Acronym / sponsor ID
- AIBU-FTR-EY-01
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Temporomandibular Joint Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Temporomandibular joint (TMJ) disorders are common problems in the society and involve the masticator muscles, jaw joint and related structures. Since TMJ disorders affect functions such as eating and speaking, they can cause important problems in the daily life of the patient. Therefore, its diagnosis and treatment are of great importance. In the treatment of these patients, methods such as analgesic and anti-inflammatory drugs, splint, exercise, physical therapy modalities can be applied.
Detailed description
Although the prevalence of TMJ disease detected in the community is between 40-60%, the rate of symptoms or clinical findings was reported to be 87% in a study including 1040 people. Incomplete clarification of the etiology and pathogenesis, the lack of standard diagnostic and treatment approaches cause patients to learn to live with this problem, and severe pain and limitation of movement cause a decrease in quality of life and loss of workforce. Specific pathologies such as systemic inflammatory diseases, tumor, fracture, developmental anomaly cause temporomandibular joint diseases. It also causes a wider group of non-specific TMB originating from the musculoskeletal system.When the literature was reviewed, no publications on the frequency of TMJ joint disease were found in medical faculty students.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Group | – | –Demographic data, symptoms for TMJ of the students will be recorded. Physical examination will be included range of motion of temporomandibular joint, right and left TMJ lateral range of motion, whether there is a gradual opening, during deflection and deviation during the opening and subluxation for palpation and measurements. Opening and closing clicks, crepitation and popping will be recorded during palpation. Deep palpation of the skin, masseter and temporal muscles will be determined, posture analysis will be recorded and dental interventions, missing teeth, orthodontic treatments and bruxism histories will be taken. An appropriate diagnosis will be determined for students who are found to have pathology as a result of all these examinations and information about this diagnosis will be provided. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We planned to include 500 volunteer students between the ages of 18-35, studying at Bolu Abant Izzet Baysal University Faculty of Medicine, with or without TMJ symptoms and agreeing to participate in the study.
Key inclusion criteria (2 listed)
- Being a medical student
- Being between the ages of 18-35
Key exclusion criteria (1 listed)
- Students who do not want to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mouth opening
Time frame: Baseline
The patient opens her mouth to the maximum, the lower border of the anterior upper teeth and the distance to the upper border of the lower teeth are measured.
Tenderness in the masseter and temporal muscles on deep palpation
Time frame: Baseline
Tenderness in the masseter and temporal muscles on deep palpation
Click in the temporomandibular joint
Time frame: Baseline
The patient's temporomandibular joint is palpated, and it is checked whether there is click or popping when opening or closing the mouth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Temporomandibular Joint Disorders
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Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
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Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
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Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Yakşi, MD principal investigator
Abant İzzet Baysal University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorders, run by Abant Izzet Baysal University at 1 site 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 1 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Mouth opening (time frame: Baseline). 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?
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 3 Aug 2021.