TMDNCT07351812
Two Treatment Modalities for Myogenous Temporomandibular Disorders
A study testing Stabilization Appliance and Ear Stent in people with TMD, run by Alexandria University at 1 site in Egypt.
Trial summary
Temporomandibular disorder (TMD) is a common condition with multifactorial etiology, including trauma, emotional stress, parafunctional habits, and occlusal discrepancies. TMD may be classified as myogenous, involving the masticatory and cervical muscles, or arthrogenous, affecting the temporomandibular joint… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- TMD
- What is being tested?
- Stabilization Appliance and Ear Stent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants presenting with pain score grading at least 4 out of 10 on NRS.
- Participants with fully dentate type I occlusion.
- Patients experiencing no neurological disorders.
Who cannot join
- Patients with arthrogenous TMJ will be excluded by Magnetic Resonance Imagining (MRI)
- Patients who have clicking or crepitation.
- Previous history of TMD treatment.
- History of recent trauma.
- The presence of systemic diseases (i.e., rheumatoid arthritis, osteoarthritis myologic or arthrological disease).
- Vascular disease (migraine and hypertension).
- Participants with uncontrolled systemic disease (diabetes), hematologic or neurologic disorders or inflammatory diseases.
- Patients who: Underwent trigger point myofascial injection, intramuscular stimulation, or dry needling in the last six months or Underwent neck and/or shoulder surgery in the last year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Faculty of Dentistry
Alexandria
Alaa F Mohamed, MS, alaa127fikrey@gmail.com
Alaa F Mohamed, BDS
About this study
Official title: Evaluation of Two Treatment Modalities for Myogenous Temporomandibular Disorders: A Randomized Controlled Trial
Temporomandibular disorder (TMD) is a common condition with multifactorial etiology, including trauma, emotional stress, parafunctional habits, and occlusal discrepancies. TMD may be classified as myogenous, involving the masticatory and cervical muscles, or arthrogenous, affecting the temporomandibular joint structures. Management approaches range from noninvasive to invasive methods. The intraoral stabilization appliance (SA) is a widely used noninvasive treatment, while the ear stent (ES) has recently been introduced for managing myogenous TMD.
Aim: This randomized clinical trial aims to compare the effectiveness of SA and ES in the management of myogenous TMD.
- Conditions
- TMD
- Being tested
- Stabilization Appliance, Ear Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilization ApplianceOther
Participants will receive a maxillary stabilization appliance fabricated from 2-mm hard thermoplastic material using diagnostic casts. The appliance fit will be verified, and patients will be instructed to wear it for 3 months.
Ear StentOther
Participants will undergo ENT evaluation prior to ear impression taking. Custom ear stents will be fabricated from soft addition silicone and hollowed to prevent hearing impairment.
| Study group | Role | What they receive |
|---|---|---|
| Stabilization appliance | Experimental | Maxillary and mandibular impressions will be taken using irreversible hydrocolloid and poured immediately with Type IV dental stone to obtain study casts. A maxillary stabilization appliance will be fabricated according to Okeson et al. using 2-mm hard thermoplastic sheets. The appliance will have a flat occlusal surface with buccal extensions, and its fit and retention will be verified. Participants will wear the appliance for 3 months. Surface electromyography of the temporalis and masseter muscles will be recorded at baseline and after 3 months to assess changes in muscle activity Receives: Other: Stabilization Appliance |
| Ear stent | Active comparator | Participants will undergo ENT evaluation to exclude ear pathology and remove cerumen. Ear impressions will be taken using soft addition silicone injected with a 3.5-mm syringe and sent to a hearing-aid laboratory for fabrication. The stent will be hollowed longitudinally to prevent hearing impairment. Patients will be instructed to wear the stent full-time, removing it only during meals, showering, or swimming Receives: Other: Ear Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle activity
surface electromyography will be used to assess the temporalis and masseter muscles. The electrodes detect the electrical potentials generated by muscle fibers when they contract. This electrical activity is amplified and recorded by an electromyograph machine
Measured: Baseline and 3 months
Change in mouth opening
Measure the distance (in mm) between the incisal edge of the maxillary and mandibular central incisors
Measured: Baseline and 3 months
Secondary outcomes (1)
Change in pain
NRS will be measured from the patient mark from 0 to 10, where 0 representing no pain and 10 representing the worst pain.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351812
- Sponsor's protocol ID
- 0999_11/2024
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Treatment Modalities for Myogenous Temporomandibular Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07351812
- Acronym / sponsor ID
- 0999_11/2024
- Conditions
- TMD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 20 Jan 2026 (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.
Temporomandibular disorder (TMD) is a common condition with multifactorial etiology, including trauma, emotional stress, parafunctional habits, and occlusal discrepancies. TMD may be classified as myogenous, involving the masticatory and cervical muscles, or arthrogenous, affecting the temporomandibular joint structures. Management approaches range from noninvasive to invasive methods. The intraoral stabilization appliance (SA) is a widely used noninvasive treatment, while the ear stent (ES) has recently been introduced for managing myogenous TMD.
Aim: This randomized clinical trial aims to compare the effectiveness of SA and ES in the management of myogenous TMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilization appliance | Experimental | Other: Stabilization ApplianceMaxillary and mandibular impressions will be taken using irreversible hydrocolloid and poured immediately with Type IV dental stone to obtain study casts. A maxillary stabilization appliance will be fabricated according to Okeson et al. using 2-mm hard thermoplastic sheets. The appliance will have a flat occlusal surface with buccal extensions, and its fit and retention will be verified. Participants will wear the appliance for 3 months. Surface electromyography of the temporalis and masseter muscles will be recorded at baseline and after 3 months to assess changes in muscle activity |
| Ear stent | Active comparator | Other: Ear StentParticipants will undergo ENT evaluation to exclude ear pathology and remove cerumen. Ear impressions will be taken using soft addition silicone injected with a 3.5-mm syringe and sent to a hearing-aid laboratory for fabrication. The stent will be hollowed longitudinally to prevent hearing impairment. Patients will be instructed to wear the stent full-time, removing it only during meals, showering, or swimming |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants presenting with pain score grading at least 4 out of 10 on NRS.
- Participants with fully dentate type I occlusion.
- Patients experiencing no neurological disorders.
Key exclusion criteria (8 listed)
- Patients with arthrogenous TMJ will be excluded by Magnetic Resonance Imagining (MRI)
- Patients who have clicking or crepitation.
- Previous history of TMD treatment.
- History of recent trauma.
- The presence of systemic diseases (i.e., rheumatoid arthritis, osteoarthritis myologic or arthrological disease).
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 |
|---|---|---|
| Stabilization ApplianceParticipants will receive a maxillary stabilization appliance fabricated from 2-mm hard thermoplastic material using diagnostic casts. The appliance fit will be verified, and patients will be instructed to wear it for 3 months. | Other | Stabilization appliance |
| Ear StentParticipants will undergo ENT evaluation prior to ear impression taking. Custom ear stents will be fabricated from soft addition silicone and hollowed to prevent hearing impairment. | Other | Ear stent |
Primary outcome
Change in Muscle activity
Time frame: Baseline and 3 months
surface electromyography will be used to assess the temporalis and masseter muscles. The electrodes detect the electrical potentials generated by muscle fibers when they contract. This electrical activity is amplified and recorded by an electromyograph machine
Change in mouth opening
Time frame: Baseline and 3 months
Measure the distance (in mm) between the incisal edge of the maxillary and mandibular central incisors
1 secondary outcome
Change in pain
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilization Appliance and Ear Stent in people with TMD, run by Alexandria University at 1 site in Egypt.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa F Mohamed, BDS (01018135577, alaa127fikrey@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle activity (time frame: Baseline and 3 months). 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?
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 20 Jan 2026.