Health TrialsbyHealthPanel

Impact of Breather Device on Ventilatory Effort in Patient With MTMD

ConditionTMD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorCairo University

About this trial

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?.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Sixty female patients who fulfilled the RDC/TMD criteria of myofascial pain and the presence of parafunctional habits, such as bruxism, teeth grinding, mouth breathing, and lip biting.

The Patient's ages will range from 20 to 40 years.

Disqualifiers

patients undergo surgery or trauma in the orofacial region; systemic or degenerative odontologic disease.

The patient has Surgery or trauma in the spine and upper limb.

Patients suffering from rheumatic diseases and other severe comorbidities.

Patients suffering from any respiratory diseases (restrictive, obstructive, suppurative diseases).

Trial design

Design model

Parallel

Treatments tested in this trial

  • the breather device

    Device

    investigate the effect of the breather device on ventilatory effort and in patients with myogenic temporomandibular joint disorders

  • conventional exercise program

    Other intervention

    -Therapeutic Ultrasound (US): Ultrasound therapy will be applied at the site of pain over the TMJ area with Frequency: 1 MHz, Mode: continuous, Duration: 6 min. each session 2-Myofascial release for masticatory muscles 3-The self-exercise Self exercise: include simplified myo-functional therapy. 10 repetitions, three: five times per day 4-Techniques to correct deglutition: swallowing a small amount of water and speaking while holding a semi-hard small object between the dental arches 5-Relaxation exercise of Masticator Muscle:10 repetitions, three. 6-Strain-counterstain (SCS): applied on the tender or trigger points of neck muscles on improving pain and pressure pain sensitivity in neck muscles

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Participant Group/ArmExperimental treatment 2 interventions
Group B: Control group/ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
4 weeks
2

Surface electromyography (sEMG):

To evaluate nerve-muscle activity during static conditions and active movements of the scalene muscle and sternocleidomastoid muscle

Time frame
4 weeks

Secondary outcomes

1

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

Time frame
4 weeks
2

Numeric Pain Rating Scale (NPRS)

To assess neck Pain intensity on a scale from 0 to 10 using whole Arabic numbers.

Time frame
4 weeks
3

craniocervical angle measuring

Kinovea software

Time frame
4 weeks
4

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)

Time frame
4 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Misr University for Science and Technology

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: