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

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.

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

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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