Temporomandibular Joint Dysfunction SyndromeNCT05271396
Respiratory Functions and Respiratory Muscle Strength in Patients With Temporomandibular Joint Dysfunction
An observational study of Temporomandibular Joint Dysfunction Syndrome, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
In our study, it was aimed to evaluate respiratory functions and respiratory muscle strength in patients diagnosed with temporomandibular dysfunction (TMD) and to compare them with healthy individuals. Read more about this study
- Who is it for?
- Ages 17 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- Clinical Assessment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Aug 2021to 11 Feb 2022
- 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 17 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The population of the study consists of cases diagnosed with TMD in Batman Training and Research Hospital between August 2021 and December 2021 and individuals who comply with the World Health Organization (WHO) definition of healthy person. The sample size of the study was calculated using the G-Power 3.1 (G-Power, Germany) program. The sample size was found to be 23 individuals in each group and a total of 46 individuals, with effect size 0.75, alpha 5%, and test power 80%.
Who may be able to join
- Volunteer to participate in the study.
- To be diagnosed with TMD for the TMD group,
- To be healthy according to WHO definition for healthy matched group
- Being between the ages of 17-50.
Who cannot join
- Having any previous pulmonary disease.
- To have experienced a TMD problem due to trauma.
- Having covid-19 in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
In our study, it was aimed to evaluate respiratory functions and respiratory muscle strength in patients diagnosed with temporomandibular dysfunction (TMD) and to compare them with healthy individuals. The study was conducted with a total of 46 participants, 23 of whom were diagnosed with TMD and 23 healthy individuals, at Batman Training and Research Hospital between August 2021 and December 2021. In the evaluation, the demographic information and clinical findings of the participants were recorded. Mandible movements were evaluated with a digital caliper. For TMJ, the Visual Analogue Scale (VAS) was used to measure the severity of pain at rest and during activity. Cervical lordosis and shoulder posture assessment was done by distance measurement. Fonseca Anamnestic Index was used for TMD severity classification. Spirometric measurement was performed to evaluate respiratory functions of all participants and intraoral pressure measurement was performed to determine respiratory muscle strength. Statistical analyzes were performed using the IBM SPSS Statistics 26 program. Significance level was accepted as p<0.05.
Read the detailed description
In our study, it was aimed to evaluate respiratory functions and respiratory muscle strength in patients diagnosed with temporomandibular dysfunction (TMD) and to compare them with healthy individuals. The study was conducted with a total of 46 participants, 23 of whom were diagnosed with TMD and 23 healthy individuals, at Batman Training and Research Hospital between August 2021 and December 2021. In the evaluation, the demographic information and clinical findings of the participants were recorded. Mandible movements were evaluated with a digital caliper. For TMJ, the Visual Analogue Scale (VAS) was used to measure the severity of pain at rest and during activity. Cervical lordosis and shoulder posture assessment was done by distance measurement. Fonseca Anamnestic Index was used for TMD severity classification. Spirometric measurement was performed to evaluate respiratory functions of all participants and intraoral pressure measurement was performed to determine respiratory muscle strength. Statistical analyzes were performed using the IBM SPSS Statistics 26 program. Significance level was accepted as p<0.05.
- Being tested
- Clinical Assessment
- Keywords
- Temporomandibular Joint Dysfunction Syndrome
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical AssessmentOther
The demographic information and clinical findings of the participants were recorded. Mandible movements evaluation with a digital caliper. The Visual Analogue Scale (VAS) to measure the severity of pain at rest and during activity. Cervical lordosis and shoulder posture assessment, Fonseca Anamnestic Index for TMD severity classification. Spirometric measurement to evaluate respiratory functions of all participants and intraoral pressure measurement to determine respiratory muscle strength.
| Study group | Role | What they receive |
|---|---|---|
| Temporomandibular Joint Dysfunction Group | Being diagnosed with Temporomandibular Joint Dysfunction Receives: Other: Clinical Assessment | |
| Healthy-matched Group | Being healthy according to WHO criteria Receives: Other: Clinical Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 (liter)
This is the amount of air with pulmonary function test that the patient can force out of their lungs in one second.
Measured: at the enrollment
FEV1 (%-percentage)
This is the percentage of air with pulmonary function test that the patient can force out of their lungs in one second.
Measured: at the enrollment
FVC (liter)
This is the greatest total amount of air patient can forcefully breathe out after breathing in as deeply as possible.
Measured: at the enrollment
FEV1/FVC (percentage)
The FEV1/FVC ratio is a number that represents the percentage of patient lung capacity patient is able to exhale in one second.
Measured: at the enrollment
Inspiratory muscle test
Maximal inspiratory pressure (MIP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
Measured: at the enrollment
Expiratory muscle test
Maximal expiratory pressure (MEP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
Measured: at the enrollment
Secondary outcomes (4)
Evaluation of Mandible Movements
Maximum mouth opening was evaluated with a digital caliper. In the measurement of maximum mouth opening, the patient was asked to open his mouth as wide as possible. The distance between the cutting edge of the upper incisor and the cutting edge of the lower incisor was measured in mm.
Measured: at the enrollment
Cervical Lordosis and Shoulder Posture Evaluation
Auxiliary tools such as double-tri square, caliper, tape measure and ruler were used for distance measurements. While the patient was standing, the wall behind was taken as a reference, and the wall-acromion, wall-tragus, tragus-acromion and chin sternal notch were measured in centimeters (cm) in free posture. Participants were asked to look straight ahead, in the free posture used in daily life, their heels against the wall, their feet open at hip level. Measurements were made on the right and left sides with the help of ruler and tape measure.
Measured: at the enrollment
Pain assessment
The Visual Analogue Scale (VAS) was used to evaluate the pain intensity of the participants at rest and during activity for the temporomandibular joint. The participants were told what the meaning of the number values between 0 and 10 on the horizontal chart, divided into 10 equal parts of 100 mm. "No pain" was 0 points, "Unbearable pain" was 10 points, "Moderate pain" was 5 points. Participants were asked to mark one of the values in line with these explanations and the values were recorded.
Measured: at the enrollment
Temporomandibular joint dysfunction classification (Fonseca Index)
Fonseca Index consists of 10 questions. Participants were asked to answer each question. The scoring method was calculated as 'Yes (10 points)', 'Sometimes (5 points)' and 'No (0 points)'.
Classification; TMD-No (0-15 points), Mild-TMD (20-45 points), Moderate-TMD (50-65 points), and Severe-TMD (70-100 points)
Measured: at the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start6 Aug 2021
- Primary completion1 Dec 2021
- Study completion11 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Dysfunction SyndromeStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Saka, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271396
- Sponsor's protocol ID
- ssaka3
- Status last verified
- Mar 2022
- First submitted
- 17 Feb 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Functions and Respiratory Muscle Strength in Patients With Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT05271396
- Acronym / sponsor ID
- ssaka3
- Keywords
- Temporomandibular Joint Dysfunction Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 9 Mar 2022 (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.
In our study, it was aimed to evaluate respiratory functions and respiratory muscle strength in patients diagnosed with temporomandibular dysfunction (TMD) and to compare them with healthy individuals. The study was conducted with a total of 46 participants, 23 of whom were diagnosed with TMD and 23 healthy individuals, at Batman Training and Research Hospital between August 2021 and December 2021. In the evaluation, the demographic information and clinical findings of the participants were recorded. Mandible movements were evaluated with a digital caliper. For TMJ, the Visual Analogue Scale (VAS) was used to measure the severity of pain at rest and during activity. Cervical lordosis and shoulder posture assessment was done by distance measurement. Fonseca Anamnestic Index was used for TMD severity classification. Spirometric measurement was performed to evaluate respiratory functions of all participants and intraoral pressure measurement was performed to determine respiratory muscle strength. Statistical analyzes were performed using the IBM SPSS Statistics 26 program. Significance level was accepted as p<0.05.
Detailed description
In our study, it was aimed to evaluate respiratory functions and respiratory muscle strength in patients diagnosed with temporomandibular dysfunction (TMD) and to compare them with healthy individuals. The study was conducted with a total of 46 participants, 23 of whom were diagnosed with TMD and 23 healthy individuals, at Batman Training and Research Hospital between August 2021 and December 2021. In the evaluation, the demographic information and clinical findings of the participants were recorded. Mandible movements were evaluated with a digital caliper. For TMJ, the Visual Analogue Scale (VAS) was used to measure the severity of pain at rest and during activity. Cervical lordosis and shoulder posture assessment was done by distance measurement. Fonseca Anamnestic Index was used for TMD severity classification. Spirometric measurement was performed to evaluate respiratory functions of all participants and intraoral pressure measurement was performed to determine respiratory muscle strength. Statistical analyzes were performed using the IBM SPSS Statistics 26 program. Significance level was accepted as p<0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporomandibular Joint Dysfunction Group | – | Other: Clinical AssessmentBeing diagnosed with Temporomandibular Joint Dysfunction |
| Healthy-matched Group | – | Other: Clinical AssessmentBeing healthy according to WHO criteria |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The population of the study consists of cases diagnosed with TMD in Batman Training and Research Hospital between August 2021 and December 2021 and individuals who comply with the World Health Organization (WHO) definition of healthy person. The sample size of the study was calculated using the G-Power 3.1 (G-Power, Germany) program. The sample size was found to be 23 individuals in each group and a total of 46 individuals, with effect size 0.75, alpha 5%, and test power 80%.
Key inclusion criteria (4 listed)
- Volunteer to participate in the study.
- To be diagnosed with TMD for the TMD group,
- To be healthy according to WHO definition for healthy matched group
- Being between the ages of 17-50.
Key exclusion criteria (3 listed)
- Having any previous pulmonary disease.
- To have experienced a TMD problem due to trauma.
- Having covid-19 in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical AssessmentThe demographic information and clinical findings of the participants were recorded. Mandible movements evaluation with a digital caliper. The Visual Analogue Scale (VAS) to measure the severity of pain at rest and during activity. Cervical lordosis and shoulder posture assessment, Fonseca Anamnestic Index for TMD severity classification. Spirometric measurement to evaluate respiratory functions of all participants and intraoral pressure measurement to determine respiratory muscle strength. | Other | Healthy-matched Group, Temporomandibular Joint Dysfunction Group |
Primary outcome
FEV1 (liter)
Time frame: at the enrollment
This is the amount of air with pulmonary function test that the patient can force out of their lungs in one second.
FEV1 (%-percentage)
Time frame: at the enrollment
This is the percentage of air with pulmonary function test that the patient can force out of their lungs in one second.
FVC (liter)
Time frame: at the enrollment
This is the greatest total amount of air patient can forcefully breathe out after breathing in as deeply as possible.
FEV1/FVC (percentage)
Time frame: at the enrollment
The FEV1/FVC ratio is a number that represents the percentage of patient lung capacity patient is able to exhale in one second.
Inspiratory muscle test
Time frame: at the enrollment
Maximal inspiratory pressure (MIP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
Expiratory muscle test
Time frame: at the enrollment
Maximal expiratory pressure (MEP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
4 secondary outcomes
Evaluation of Mandible Movements
Time frame: at the enrollment
Cervical Lordosis and Shoulder Posture Evaluation
Time frame: at the enrollment
Pain assessment
Time frame: at the enrollment
Temporomandibular joint dysfunction classification (Fonseca Index)
Time frame: at the enrollment
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 9 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dysfunction Syndrome, run by Halic 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 4 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 9 Mar 2022. 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?
FEV1 (liter) (time frame: at the enrollment). The study lists 6 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 9 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.