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NCT Number: NCT06562556

Impact of Breather Device on Ventilatory Effort in Patient With MTMD

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?.

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Key information

Conditions

TMD

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Randomized controlled trial which will be conducted on sixty female patients with chronic pain myogenous TMD for more than three months will be included in our study., their ages will range from 20 to 30 years. They will be selected from students of Misr University for Science and Technology to be enrolled in this study. They will participate in this study for 4 weeks The patients will participate and randomly be assigned into two equal groups. Group A: (Experimental group) Thirty patients, will receive a combined treatment program containing respiratory muscle training by the breather device with a conventional exercise program for MTMD for four consecutive weeks (3 sessions/ week).

Group B: (Control group) Thirty patients, who will receive a conventional exercise program for MTMD for four consecutive weeks (3 sessions/ week)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria:
  • 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.

4- Patients with a waist-height ratio measuring less than 0.5. 5- Patients with a craniocervical angle measuring from 30 to 50° (Bo-Been et al., 2016).

6- the patients have points from 20-65 on the Fonseca Anamnestic Index (FAI) 7- the patients have the willingness to participate in this study. 8- All patients will sign a consent form before starting the study.

Exclusion criteria

Patients will meet one of the following criteria will be excluded from the study:

  • 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).
  • Patients suffering from neurological disorders affecting respiratory muscles or any muscular dystrophies

Treatment and study plan

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

-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

Primary outcomes

  1. spirometer

    Time frame: 4 weeks

    measure ventilatory function test in percentage

    • Forced expiratory volume in the first second (FEV1)
    • Forced vital capacity (FVC).
    • FEV1/FVC ratio.
    • Maximal Ventilator Volume (MVV)

  2. Surface electromyography (sEMG):

    Time frame: 4 weeks

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

Secondary outcomes

  1. Fonseca Anamnestic Index (FAI)

    Time frame: 4 weeks

    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

  2. Numeric Pain Rating Scale (NPRS)

    Time frame: 4 weeks

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

  3. craniocervical angle measuring

    Time frame: 4 weeks

    Kinovea software

  4. The Oral Health Impact Profile Questionnaire OHIP-14

    Time frame: 4 weeks

    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)

  5. Tape Measurement tool and height scale

    Time frame: preassessment

    To measure the waist/ height ratio

Study contacts

Contact information is provided by the study sponsor or research team.

Hany Ezzat, Assistant professor

CONTACT

[email protected]

01001746517

weaam Hasaneen, assistant lecturer

CONTACT

[email protected]

010111421509

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Impact of Breather Device on Ventilatory Effort in Patient With Myogenic Temporomandibular Joint Disorders

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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