- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05271396
Respiratory Functions and Respiratory Muscle Strength in Patients With Temporomandibular Joint Dysfunction
March 4, 2022 updated by: Seda Saka, Halic University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İstanbul, Turkey
- Haliç University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 50 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
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%.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Having any previous pulmonary disease.
- To have experienced a TMD problem due to trauma.
- Having covid-19 in the last 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Temporomandibular Joint Dysfunction Group
Being diagnosed with Temporomandibular Joint Dysfunction
|
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.
|
Healthy-matched Group
Being healthy according to WHO criteria
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at the enrollment
|
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.
|
at the enrollment
|
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.
|
at the enrollment
|
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.
|
at the enrollment
|
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).
|
at the enrollment
|
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).
|
at the enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Mandible Movements
Time Frame: at the enrollment
|
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.
|
at the enrollment
|
Cervical Lordosis and Shoulder Posture Evaluation
Time Frame: at the enrollment
|
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.
|
at the enrollment
|
Pain assessment
Time Frame: at the enrollment
|
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.
|
at the enrollment
|
Temporomandibular joint dysfunction classification (Fonseca Index)
Time Frame: at the enrollment
|
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) |
at the enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 6, 2021
Primary Completion (ACTUAL)
December 1, 2021
Study Completion (ACTUAL)
February 11, 2022
Study Registration Dates
First Submitted
February 17, 2022
First Submitted That Met QC Criteria
March 4, 2022
First Posted (ACTUAL)
March 9, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 9, 2022
Last Update Submitted That Met QC Criteria
March 4, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ssaka3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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