BruxismNCT06894472
A Comparative Study of EMG Biofeedback and Pharmacotherapy for the Treatment of Masticatory Muscle Hyperactivity in Bruxism Patients
A study testing Electromyography biofeedback and Pharmacotherapy in people with Bruxism, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This study examines the effect of electromyography biofeedback on masticatory muscles hyperactivity on patients with bruxism. Read more about this study
- Who is it for?
- Ages 20 to 25 years
- Conditions the study is for
- Bruxism
- What is being tested?
- Electromyography biofeedback and Pharmacotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Mar 2025to 1 May 2025
- 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 20 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Twenty adult subjects with definite mild to moderate bruxism examined by a dentist prior to the study.
- Tenderness of masticatory muscles on palpation grade one and two according to the digital palpating scale
- Mild to moderate myofascial pain around the temporomandibular joint causing discomfort in the morning.
Who cannot join
- Took any Botox or PRP injection treatment for this condition for the last six months
- Had any advanced periodontal disease.
- Any intraoral fixed splints.
- Pregnancy.
- Under psychiatric care.
- Parkinson
- Have any visual or auditory impairment.
- Any cervical posture abnormalities.
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
Misr University for Science and Technology
Giza
Sara Abdullah mohamed elsamahy, PhD, +20 11 51401438, Saraaelsamahy@gmail.com
About this study
This study examines the effect of electromyography biofeedback on masticatory muscles hyperactivity on patients with bruxism.
Read the detailed description
Bruxism is a movement disorder characterized by excessive activity of the masticatory muscles, resulting in teeth clenching and grinding. It affects 50% to 95% of the adult population. Unlike normal, voluntary chewing movements associated with eating, bruxism involves involuntary jaw muscle contractions that cause tension, leading to muscle soreness and pain. Common symptoms include localized muscle tenderness, orofacial pain, anxiety, stress, fatigue, headaches (especially in the temporal region), restricted mouth opening, and temporomandibular joint stiffness. These symptoms can disrupt sleep, causing transitions from deep to light sleep, increased micro-arousals, and sleep fragmentation, leading to daytime fatigue that impacts social life and work performance.
Bruxism can also lead to masticatory muscle hypertrophy (especially the masseter), tongue burning, linea alba on the cheeks, excessive tooth wear, damage to dental prosthetics, changes in saliva secretion, severe craniofacial pain, and TMJ stiffness. Common treatments for bruxism-related pain often involve medications like Botox, clonazepam, or diazepam, but these are typically temporary and do not address the underlying causes. Moreover, long-term use of these medications may cause complications, and their high cost can limit accessibility.
Non-pharmacological treatments for bruxism include biofeedback, muscle relaxation exercises, occlusal splint therapy, and psychotherapy. Biofeedback, which provides real-time information on bodily functions, helps individuals recognize and modify harmful behaviors. Electromyography (EMG) biofeedback, recognized as effective for temporomandibular disorders (including bruxism), is endorsed by the American Association of Psychophysiology and Biofeedback (AAPB) as an evidence-based intervention.
This study aims to compare the effects of EMG biofeedback training versus oral medications in reducing masticatory muscle hyperactivity in bruxism patients, focusing on addressing the underlying pathophysiology, a topic that, to the authors' knowledge, has not been explored in previous research.
- Conditions
- Bruxism
- Being tested
- Electromyography biofeedback, Pharmacotherapy
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyography biofeedbackOther
Participants in the experimental group will receive surface electromyography (SEMG) feedback training, targeting the Masseter muscle, for 40 minutes per session according to the Evidence-Based practice since longer practice may become counterproductive due to fatigue and loss of focus. The frequency of the sessions will be 3 sessions/week for 4 weeks.
PharmacotherapyDrug
Pharmacotherapy will be received by all participants in the two groups in the form of multi relaxant (cyclobenzaprine) 10 MG twice daily for 4 weeks \& anti inflammatory (non steroidal anti-inflammatory drugs).
| Study group | Role | What they receive |
|---|---|---|
| Electromyography biofeedback + Pharmacotherapy | Experimental | This group will be treated with electromyography biofeedback for one month with a frequency of 3 sessions/week in addition to the pharmacotherapy which prescribed by the dentist. Receives: Other: Electromyography biofeedback; Drug: Pharmacotherapy |
| Pharmacotherapy | Other | This group will be treated only with the pharmacotherapy which prescribed by the dentist. Receives: Drug: Pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Masseter Hyperactivity
The assessment of Masseter muscle hyperactivity will be carried out by the digital palpating scale according to the following criteria: Grade Zero (0): when the muscle palpated and there is no pain or tenderness reported by the patient. Grade (1): Recorded if the patient response the palpation is uncomfortable (tenderness or soreness). Grade (2): is recorded if the patient experiences definite discomfort or pain. Grade (3): is recorded if the patient shows evasive action or eye tearing or verbalizes a desire not to have the area palpated again.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start26 Mar 2025 (estimated)
- Primary completion26 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdullah mohamed elsamahy, Beni-Suef University
- Investigators
- Sara Abdullah mohamed elsamahy, PhD, Principal investigator, LecturerMohamed Farouk Abdel-Latif, PhD, Principal investigator, LecturerAmal Ahmed Mohamed Morsi, PhD, Principal investigator, LecturerWafaa Atef Abd Allah, PhD, Principal investigator, LecturerMyassar Ayman Amine, M.Sc, Principal investigator, Ass. Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894472
- Sponsor's protocol ID
- FPTBSUREC/0805/2325
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of EMG Biofeedback and Pharmacotherapy for the Treatment of Masticatory Muscle Hyperactivity in Bruxism Patients
- ClinicalTrials.gov ID
- NCT06894472
- Acronym / sponsor ID
- FPTBSUREC/0805/2325
- Conditions
- Bruxism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 26 Mar 2025 (estimated)
- Primary completion
- 26 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 25 Mar 2025 (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.
This study examines the effect of electromyography biofeedback on masticatory muscles hyperactivity on patients with bruxism.
Detailed description
Bruxism is a movement disorder characterized by excessive activity of the masticatory muscles, resulting in teeth clenching and grinding. It affects 50% to 95% of the adult population. Unlike normal, voluntary chewing movements associated with eating, bruxism involves involuntary jaw muscle contractions that cause tension, leading to muscle soreness and pain. Common symptoms include localized muscle tenderness, orofacial pain, anxiety, stress, fatigue, headaches (especially in the temporal region), restricted mouth opening, and temporomandibular joint stiffness. These symptoms can disrupt sleep, causing transitions from deep to light sleep, increased micro-arousals, and sleep fragmentation, leading to daytime fatigue that impacts social life and work performance.
Bruxism can also lead to masticatory muscle hypertrophy (especially the masseter), tongue burning, linea alba on the cheeks, excessive tooth wear, damage to dental prosthetics, changes in saliva secretion, severe craniofacial pain, and TMJ stiffness. Common treatments for bruxism-related pain often involve medications like Botox, clonazepam, or diazepam, but these are typically temporary and do not address the underlying causes. Moreover, long-term use of these medications may cause complications, and their high cost can limit accessibility.
Non-pharmacological treatments for bruxism include biofeedback, muscle relaxation exercises, occlusal splint therapy, and psychotherapy. Biofeedback, which provides real-time information on bodily functions, helps individuals recognize and modify harmful behaviors. Electromyography (EMG) biofeedback, recognized as effective for temporomandibular disorders (including bruxism), is endorsed by the American Association of Psychophysiology and Biofeedback (AAPB) as an evidence-based intervention.
This study aims to compare the effects of EMG biofeedback training versus oral medications in reducing masticatory muscle hyperactivity in bruxism patients, focusing on addressing the underlying pathophysiology, a topic that, to the authors' knowledge, has not been explored in previous research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electromyography biofeedback + Pharmacotherapy | Experimental | Other: Electromyography biofeedback, Drug: PharmacotherapyThis group will be treated with electromyography biofeedback for one month with a frequency of 3 sessions/week in addition to the pharmacotherapy which prescribed by the dentist. |
| Pharmacotherapy | Other | Drug: PharmacotherapyThis group will be treated only with the pharmacotherapy which prescribed by the dentist. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Twenty adult subjects with definite mild to moderate bruxism examined by a dentist prior to the study.
- Tenderness of masticatory muscles on palpation grade one and two according to the digital palpating scale
- Mild to moderate myofascial pain around the temporomandibular joint causing discomfort in the morning.
Key exclusion criteria (8 listed)
- Took any Botox or PRP injection treatment for this condition for the last six months
- Had any advanced periodontal disease.
- Any intraoral fixed splints.
- Pregnancy.
- Under psychiatric care.
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 |
|---|---|---|
| Electromyography biofeedbackParticipants in the experimental group will receive surface electromyography (SEMG) feedback training, targeting the Masseter muscle, for 40 minutes per session according to the Evidence-Based practice since longer practice may become counterproductive due to fatigue and loss of focus. The frequency of the sessions will be 3 sessions/week for 4 weeks. | Other | Electromyography biofeedback + Pharmacotherapy |
| PharmacotherapyPharmacotherapy will be received by all participants in the two groups in the form of multi relaxant (cyclobenzaprine) 10 MG twice daily for 4 weeks \& anti inflammatory (non steroidal anti-inflammatory drugs). | Drug | Electromyography biofeedback + Pharmacotherapy, Pharmacotherapy |
Primary outcome
Assessment of Masseter Hyperactivity
Time frame: 4 weeks
The assessment of Masseter muscle hyperactivity will be carried out by the digital palpating scale according to the following criteria: Grade Zero (0): when the muscle palpated and there is no pain or tenderness reported by the patient. Grade (1): Recorded if the patient response the palpation is uncomfortable (tenderness or soreness). Grade (2): is recorded if the patient experiences definite discomfort or pain. Grade (3): is recorded if the patient shows evasive action or eye tearing or verbalizes a desire not to have the area palpated again.
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 25 Mar 2025.
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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.
Sara Abdullah mohamed elsamahy, PhD principal investigator
Lecturer
Mohamed Farouk Abdel-Latif, PhD principal investigator
Lecturer
Amal Ahmed Mohamed Morsi, PhD principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyography biofeedback and Pharmacotherapy in people with Bruxism, run by Beni-Suef 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: opening soon, as of the sponsor's last update on 25 Mar 2025. 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 Sara Abdullah mohamed elsamahy, PhD (+20 11 51401438, Saraaelsamahy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Masseter Hyperactivity (time frame: 4 weeks). 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 25 Mar 2025.