TMDNCT06562556
Impact of Breather Device on Ventilatory Effort in Patient With MTMD
A study testing the breather device and conventional exercise program in people with TMD, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- TMD
- What is being tested?
- the breather device and conventional exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Breather Device on Ventilatory Effort in Patient With Myogenic Temporomandibular Joint Disorders
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
Read more
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?.
Read the detailed description
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)
- Conditions
- TMD
- Being tested
- the breather device, conventional exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the breather deviceDevice
investigate the effect of the breather device on ventilatory effort and in patients with myogenic temporomandibular joint disorders
conventional exercise programOther
-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
| Study group | Role | What they receive |
|---|---|---|
| Participant Group/Arm | Experimental | rThirty 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) Receives: Device: the breather device; Other: conventional exercise program |
| Control group/Arm | Other | Thirty patients, who will receive a conventional exercise program for MTMD for four consecutive weeks (3 sessions/ week). Receives: Other: conventional exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
spirometer
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)
Measured: 4 weeks
Surface electromyography (sEMG):
To evaluate nerve-muscle activity during static conditions and active movements of the scalene muscle and sternocleidomastoid muscle
Measured: 4 weeks
Secondary outcomes (5)
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
Measured: 4 weeks
Numeric Pain Rating Scale (NPRS)
To assess neck Pain intensity on a scale from 0 to 10 using whole Arabic numbers.
Measured: 4 weeks
craniocervical angle measuring
Kinovea software
Measured: 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)
Measured: 4 weeks
Tape Measurement tool and height scale
To measure the waist/ height ratio
Measured: preassessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TMDStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weaam Soliman Hassaneen, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562556
- Sponsor's protocol ID
- breather device for MTMD
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Walczynska-Dragon K, Baron S, Nitecka-Buchta A, Tkacz E. Correlation between TMD and cervical spine pain and mobility: is the whole body balance TMJ related? Biomed Res Int. 2014;2014:582414. doi: 10.1155/2014/582414. Epub 2014 Jun 19.
PubMed 25050363
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Breather Device on Ventilatory Effort in Patient With Myogenic Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT06562556
- Acronym / sponsor ID
- breather device for MTMD
- Conditions
- TMD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?.
Detailed description
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Participant Group/Arm | Experimental | Device: the breather device, Other: conventional exercise programrThirty 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) |
| Control group/Arm | Other | Other: conventional exercise programThirty patients, who will receive a conventional exercise program for MTMD for four consecutive weeks (3 sessions/ week). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the breather deviceinvestigate the effect of the breather device on ventilatory effort and in patients with myogenic temporomandibular joint disorders | Device | Participant Group/Arm |
| conventional exercise program-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 | Other | Control group/Arm, Participant Group/Arm |
Primary outcome
spirometer
Time frame: 4 weeks
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)
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
5 secondary outcomes
Fonseca Anamnestic Index (FAI)
Time frame: 4 weeks
Numeric Pain Rating Scale (NPRS)
Time frame: 4 weeks
craniocervical angle measuring
Time frame: 4 weeks
The Oral Health Impact Profile Questionnaire OHIP-14
Time frame: 4 weeks
Tape Measurement tool and height scale
Time frame: preassessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Results publication: PubMed 25050363Walczynska-Dragon K, Baron S, Nitecka-Buchta A, Tkacz E. Correlation between TMD and cervical spine pain and mobility: is the whole body balance TMJ related? Biomed Res Int. 2014;2014:582414. doi: 10.1155/2014/582414. Epub 2014 Jun 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing the breather device and conventional exercise program in people with TMD, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact weaam Hasaneen, assistant lecturer (010111421509, weaam.hosain@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spirometer (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06562556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.