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Completed

NCT Number: NCT05271396

Respiratory Functions and Respiratory Muscle Strength in Patients With Temporomandibular Joint Dysfunction

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.

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Key information

Conditions

Temporomandibular Joint Dysfunction Syndrome Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

17 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haliç University

Istanbul, Turkey (Türkiye)

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical Assessment

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

Sponsors and collaborators

Lead sponsor

Halic University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 9, 2022
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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