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

Temporomandibular Joint Dysfunction Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271396
• Other study ID #: ssaka3
• Status: Completed
• Start date: August 6, 2021
• Est. completion date: February 11, 2022

Study information

• Verified date: March 2022
• Source: Halic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 11, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• Clinical Assessment
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.

Locations

Country	Name	City	State
Turkey	Haliç University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Halic University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	at the enrollment
Secondary	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.	at the enrollment
Secondary	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.	at the enrollment
Secondary	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)	at the enrollment