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

NCT05271396 | Completed

• 1 other identifier: ssaka3
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Temporomandibular Joint Dysfunction Syndrome

Keywords

Temporomandibular Joint Dysfunction Syndrome

Outcome Measures

Primary Outcomes (6)

• FEV1 (liter)

  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)

  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)

  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)

  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

  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

  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 Outcomes (4)

• Evaluation of Mandible Movements

  at the enrollment

• Cervical Lordosis and Shoulder Posture Evaluation

  at the enrollment

• Pain assessment

  at the enrollment

• Temporomandibular joint dysfunction classification (Fonseca Index)

  at the enrollment

Study Arms (2)

Temporomandibular Joint Dysfunction Group

Being diagnosed with Temporomandibular Joint Dysfunction

Other: Clinical Assessment

Healthy-matched Group

Being healthy according to WHO criteria

Other: Clinical Assessment

Interventions

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.

Healthy-matched Group; Temporomandibular Joint Dysfunction Group

Eligibility Criteria

• Age: 17 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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%.

You may qualify if:

• 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.

You may not qualify if:

• Having any previous pulmonary disease.
• To have experienced a TMD problem due to trauma.
• Having covid-19 in the last 6 months.

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

Haliç University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 9, 2022
• Study Start: August 6, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 11, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

TU (1)