Clinical trial NCT05271396: Respiratory Functions and Respiratory Muscle Strength in Patients With Temporomandibular Joint Dysfunction
Official title: Respiratory Functions and Respiratory Muscle Strength in Patients With Temporomandibular Joint Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Joint Dysfunction Syndrome
Keywords: Temporomandibular Joint Dysfunction Syndrome
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 46
Sex: ALL
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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%.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: FEV1 (liter)
timeFrame: at the enrollment
measure: FEV1 (%-percentage)
timeFrame: at the enrollment
measure: FVC (liter)
timeFrame: at the enrollment
measure: FEV1/FVC (percentage)
timeFrame: at the enrollment
measure: Inspiratory muscle test
timeFrame: at the enrollment
measure: Expiratory muscle test
timeFrame: at the enrollment
Secondary outcomes:
measure: Evaluation of Mandible Movements
timeFrame: at the enrollment
measure: Cervical Lordosis and Shoulder Posture Evaluation
timeFrame: at the enrollment
measure: Pain assessment
timeFrame: at the enrollment
measure: Temporomandibular joint dysfunction classification (Fonseca Index)
timeFrame: at the enrollment
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Haliç University
Study officials:
References: