Impact of Breather Device on Ventilatory Effort in Patient With MTMD
NCT Number: NCT06562556
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: TMD
Interventions: DEVICE: the breather device|OTHER: conventional exercise program
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-05

Summary:
PURPOSE:

The purpose of the study is to investigate the effect of the breather device on ventilatory effort and in patients with myogenic temporomandibular joint disorders To investigate the effect of the breather device on craniocervical angle and oral Health quality in patients with myogenic temporomandibular joint disorders

BACKGROUND:

TMDs affect between 5% and 12% of the population which is presented by symptoms such as pain in the masticatory muscles with a decrease in the mandible's movement. Other symptoms include ear pain, headache, joint sounds with mandible movement, and/or functional limitations in the jaw like swallowing difficulties commonly found. (Hatice ., et al 2023) Increased prevalence of TMDs has been linked to physical, psychological, and hormonal changes throughout pubertal development. The age predisposes to the development of masticatory system problems in students since symptoms peak between the ages of 20 and 40 years. Women of breeding age are the majority of TMD sufferers. The prevalence of TMD increases globally throughout adolescence and may vary from 7% to 30% of the population (Loster ., et al2017). Alterations of body posture, upper thoracic breathing pattern, and mouth breathing constitute causal factors for the overuse of the accessory inspiratory musculature, which generates hyperactivity and consequently, alteration of head position, and mandibular traction. (Kim., et al 2017)

HYPOTHESES:

There will be no significant effect of the breather device on ventilatory effort in patients with myogenic temporomandibular joint disorders.

There will be no significant effect of the breather device on a craniocervical angle and oral Health quality in patients with myogenic temporomandibular joint disorders RESEARCH QUESTION: Does the breather device can improve ventilatory effort in patients with myogenic temporomandibular joint disorders?.

Primary Outcome Measures: spirometer, measure ventilatory function test in percentage

1. Forced expiratory volume in the first second (FEV1)
2. Forced vital capacity (FVC).
3. FEV1/FVC ratio.
4. Maximal Ventilator Volume (MVV), 4 weeks|Surface electromyography (sEMG):, To evaluate nerve-muscle activity during static conditions and active movements of the scalene muscle and sternocleidomastoid muscle, 4 weeks
Secondary Outcome Measures: Fonseca Anamnestic Index (FAI), to diagnose TMD and evaluate the severity of the disorder. FAI is a functional assessment scale, which contains 10 objective questions which there are three possible answers: no 0 points, sometimes 5 points, and yes 10 points. The total score gives the FAI classification as follows: 70-100 points, severe TMD. 45-65 points, moderate TMD. 20-40 points, mild TMD. 0-15 points, TMD-free. TMD is diagnosed on FAI scores of ≥20, 4 weeks|Numeric Pain Rating Scale (NPRS), To assess neck Pain intensity on a scale from 0 to 10 using whole Arabic numbers., 4 weeks|craniocervical angle measuring, Kinovea software, 4 weeks|The Oral Health Impact Profile Questionnaire OHIP-14, to determine oral health quality. comprises 14 items that explore seven dimensions of impact: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. The responses were classified using the Likert scale with five options ranging from "never" (0) to "very often" (4), 4 weeks|Tape Measurement tool and height scale, To measure the waist/ height ratio, preassessment