BruxismNCT07051876
Feasibility of a Clinical Trial on Physiotherapy and Mouthguards for Bruxism Using Posture and EMG Analysis
A study testing Mouthguard and Physiotherapy and Mouthguard Only in people with Bruxism and Manual Theapy, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
The purpose of this research is to determine whether a clinical trial assessing the impact of physiotherapy and mouthguards on bruxism is feasible. This includes evaluating the feasibility of participant recruitment, implementing the interventions, and collecting data using appropriate techniques. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Manual Theapy
- What is being tested?
- Mouthguard and Physiotherapy and Mouthguard Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteLebanon
- Study dates
- 21 May 2023to 2 Jul 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Confirmed diagnosis of bruxism by a qualified member of the occlusion unit department
- No history of temporomandibular disorders or other craniofacial pain conditions
- No history of neurological or psychiatric disorders
- No current use of medications that affect muscle tone or sleep
Who cannot join
- - The presence of any systemic or neuromuscular disorder affecting the jaw muscles or posture.
- Use of medications, substances, or drugs that may affect jaw muscle activity, such as muscle relaxants or stimulants.
- Lifestyle: sleep disorder, anxiety
- Presence of any oral pathology or dental prostheses that may interfere with the use of a mouthguard.
- Inability to tolerate the EMG electrodes or posture angle analysis.
- Patient who has recently undergone physiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Mouthguard and Physiotherapy on Bruxism: An EMG and Posture Angle Analysis
The purpose of this research is to determine whether a clinical trial assessing the impact of physiotherapy and mouthguards on bruxism is feasible. This includes evaluating the feasibility of participant recruitment, implementing the interventions, and collecting data using appropriate techniques. The study will focus on posture angle analysis to assess changes in posture associated with bruxism, and electromyography (EMG) to measure muscular activity. By examining these elements, the study aims to lay the groundwork for a larger clinical trial that could provide conclusive evidence regarding the efficacy of these therapies in treating bruxism.
Participants will be recruited from the USJ dental clinics following their consultation. They will be screened for bruxism using a questionnaire and a clinical examination based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
Read more
The mouthguard-only group will receive a custom-fitted mouthguard, fabricated by a qualified dentist. Participants will be instructed to wear the mouthguard during sleep for six weeks, to clean it daily, and to store it in a cool, dry place.
The mouthguard and physiotherapy group will receive both a custom-fitted mouthguard and physiotherapy. The home physiotherapy program will include posture improvement exercises, relaxation techniques, and muscle therapy targeting the head, neck, and shoulders. Participants will perform the exercises daily at home, record themselves, and submit the videos each day via a social platform (e.g., Microsoft Teams or WhatsApp, depending on patient preference) for a period of six weeks.
Read the detailed description
Participant recruitment was conducted at USJ dental clinics with support from the occlusal department and private clinic following patient consultations. Screening for bruxism involved a clinical examination and the DC/TMD questionnaire. Ethical approval was granted by the Saint Joseph University of Beirut (approval number USJ-2023-200), and informed consent was obtained from all participants.
Electromyographic (EMG) assessments were carried out by the principal investigator using a portable EMG machine (KM560). Electrodes were placed bilaterally on the masseter muscles. Participants were instructed to bite in maximum intercuspation six times for five seconds each, with rest intervals in between. The device recorded muscle activity during both contraction and relaxation phases to evaluate bruxism-related muscle function.
Forward head posture was analyzed through photogrammetry. Markers were placed at the tragus of the ear and the C7 vertebra. Lateral photographs were taken, and the craniovertebral angle was measured using image analysis software to assess postural alignment.
The physiotherapy protocol consisted of a six-week home program performed daily. It included awareness of the mandibular rest position, relaxation techniques, diaphragmatic breathing, self-massage of the masseter and temporalis muscles, stretching, coordination, and resistance exercises. Participants recorded and submitted daily videos via Teams or WhatsApp to ensure compliance.
Custom mouthguards were fabricated by the researcher. Dental impressions were taken using alginate (Hydrogum 5®), and casts were made. Mouthguards were then vacuum-formed using thermoplastic material (3A MEDES®), followed by trimming and polishing to ensure a comfortable fit.
- Conditions
- Bruxism, Manual Theapy
- Being tested
- Mouthguard and Physiotherapy, Mouthguard Only
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouthguard and PhysiotherapyDevice
Also called MANUAL THERAPY, MOUTHGUARD
The mouthguard and physiotherapy group will receive a custom-fitted mouthguard along with a physiotherapy program. The home-based physiotherapy exercises will include posture improvement routines, relaxation techniques, and targeted therapy for the muscles of the head, neck, and shoulders. These sessions will be performed daily at home for a duration of six weeks. Each participant will sign a consent form approved by the Ethics Committee of Saint Joseph University.
Mouthguard OnlyDevice
The mouthguard only group will receive a custom-fitted mouthguard, which will be fabricated by a qualified dentist. The mouthguard will be worn during sleep for 6 weeks. Participants will be instructed to clean the mouthguard daily and to store it in a cool, dry place.
| Study group | Role | What they receive |
|---|---|---|
| Mouthguard Only | Experimental | participants in this arm receive a custom-fitted thermoplastic mouthguard (3A MEDES®) fabricated by a dentist. The mouthguard is worn nightly during sleep for 6 weeks. Participants are instructed on daily cleaning and proper storage. No additional treatments are provided in this arm. Receives: Device: Mouthguard Only |
| Mouthguard and Physiotherapy | Experimental | Participants in this arm receive the same custom-fitted mouthguard as in the first arm, worn nightly for 6 weeks, along with a daily home-based physiotherapy protocol that includes:
Postural correction exercises
Mandibular awareness training
Relaxation techniques (e.g., Bae method)
Diaphragmatic breathing (5 minutes daily or 15 repetitions)
Self-massage of masseter and temporalis muscles
Stretching and jaw coordination exercises
Jaw muscle strengthening with resistance
Participants perform exercises once daily for 6 weeks and submit daily video recordings via a messaging platform (e.g., Teams or WhatsApp) to ensure compliance. Receives: Device: Mouthguard and Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Masseter Muscle Activity and Cervical Posture Angle from Baseline to 6 Weeks Measured by Surface EMG and Postural Assessment Tools.
Surface electromyography (sEMG) will be used to measure muscle activity of the masseter and temporalis during rest and clenching. A posture assessment tool will evaluate changes in head and cervical posture using digital angle measurements. Measurements will be taken at baseline and after 6 weeks of intervention.
Measured: From enrollment to the end of treatment at 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start21 May 2023
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
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 BruxismStudies of the same condition, open and under way.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051876
- Sponsor's protocol ID
- Usj-2023-200
- Status last verified
- Jul 2025
- First submitted
- 16 Apr 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barros Vde M, Seraidarian PI, Cortes MI, de Paula LV. The impact of orofacial pain on the quality of life of patients with temporomandibular disorder. J Orofac Pain. 2009 Winter;23(1):28-37.
PubMed 19264033
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mouthguard and Physiotherapy on Bruxism: An EMG and Posture Angle Analysis
- ClinicalTrials.gov ID
- NCT07051876
- Acronym / sponsor ID
- Usj-2023-200
- Conditions
- Bruxism, Manual Theapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 21 May 2023 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 4 Jul 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.
The purpose of this research is to determine whether a clinical trial assessing the impact of physiotherapy and mouthguards on bruxism is feasible. This includes evaluating the feasibility of participant recruitment, implementing the interventions, and collecting data using appropriate techniques. The study will focus on posture angle analysis to assess changes in posture associated with bruxism, and electromyography (EMG) to measure muscular activity. By examining these elements, the study aims to lay the groundwork for a larger clinical trial that could provide conclusive evidence regarding the efficacy of these therapies in treating bruxism.
Participants will be recruited from the USJ dental clinics following their consultation. They will be screened for bruxism using a questionnaire and a clinical examination based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
The mouthguard-only group will receive a custom-fitted mouthguard, fabricated by a qualified dentist. Participants will be instructed to wear the mouthguard during sleep for six weeks, to clean it daily, and to store it in a cool, dry place.
The mouthguard and physiotherapy group will receive both a custom-fitted mouthguard and physiotherapy. The home physiotherapy program will include posture improvement exercises, relaxation techniques, and muscle therapy targeting the head, neck, and shoulders. Participants will perform the exercises daily at home, record themselves, and submit the videos each day via a social platform (e.g., Microsoft Teams or WhatsApp, depending on patient preference) for a period of six weeks.
Detailed description
Participant recruitment was conducted at USJ dental clinics with support from the occlusal department and private clinic following patient consultations. Screening for bruxism involved a clinical examination and the DC/TMD questionnaire. Ethical approval was granted by the Saint Joseph University of Beirut (approval number USJ-2023-200), and informed consent was obtained from all participants.
Electromyographic (EMG) assessments were carried out by the principal investigator using a portable EMG machine (KM560). Electrodes were placed bilaterally on the masseter muscles. Participants were instructed to bite in maximum intercuspation six times for five seconds each, with rest intervals in between. The device recorded muscle activity during both contraction and relaxation phases to evaluate bruxism-related muscle function.
Forward head posture was analyzed through photogrammetry. Markers were placed at the tragus of the ear and the C7 vertebra. Lateral photographs were taken, and the craniovertebral angle was measured using image analysis software to assess postural alignment.
The physiotherapy protocol consisted of a six-week home program performed daily. It included awareness of the mandibular rest position, relaxation techniques, diaphragmatic breathing, self-massage of the masseter and temporalis muscles, stretching, coordination, and resistance exercises. Participants recorded and submitted daily videos via Teams or WhatsApp to ensure compliance.
Custom mouthguards were fabricated by the researcher. Dental impressions were taken using alginate (Hydrogum 5®), and casts were made. Mouthguards were then vacuum-formed using thermoplastic material (3A MEDES®), followed by trimming and polishing to ensure a comfortable fit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mouthguard Only | Experimental | Device: Mouthguard Onlyparticipants in this arm receive a custom-fitted thermoplastic mouthguard (3A MEDES®) fabricated by a dentist. The mouthguard is worn nightly during sleep for 6 weeks. Participants are instructed on daily cleaning and proper storage. No additional treatments are provided in this arm. |
| Mouthguard and Physiotherapy | Experimental | Device: Mouthguard and PhysiotherapyParticipants in this arm receive the same custom-fitted mouthguard as in the first arm, worn nightly for 6 weeks, along with a daily home-based physiotherapy protocol that includes: Postural correction exercises Mandibular awareness training Relaxation techniques (e.g., Bae method) Diaphragmatic breathing (5 minutes daily or 15 repetitions) Self-massage of masseter and temporalis muscles Stretching and jaw coordination exercises Jaw muscle strengthening with resistance Participants perform exercises once daily for 6 weeks and submit daily video recordings via a messaging platform (e.g., Teams or WhatsApp) to ensure compliance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- Confirmed diagnosis of bruxism by a qualified member of the occlusion unit department
- No history of temporomandibular disorders or other craniofacial pain conditions
- No history of neurological or psychiatric disorders
- No current use of medications that affect muscle tone or sleep
Key exclusion criteria (6 listed)
- - The presence of any systemic or neuromuscular disorder affecting the jaw muscles or posture.
- Use of medications, substances, or drugs that may affect jaw muscle activity, such as muscle relaxants or stimulants.
- Lifestyle: sleep disorder, anxiety
- Presence of any oral pathology or dental prostheses that may interfere with the use of a mouthguard.
- Inability to tolerate the EMG electrodes or posture angle analysis.
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 |
|---|---|---|
| Mouthguard and PhysiotherapyAlso: MANUAL THERAPY, MOUTHGUARDThe mouthguard and physiotherapy group will receive a custom-fitted mouthguard along with a physiotherapy program. The home-based physiotherapy exercises will include posture improvement routines, relaxation techniques, and targeted therapy for the muscles of the head, neck, and shoulders. These sessions will be performed daily at home for a duration of six weeks. Each participant will sign a consent form approved by the Ethics Committee of Saint Joseph University. | Device | Mouthguard and Physiotherapy |
| Mouthguard OnlyThe mouthguard only group will receive a custom-fitted mouthguard, which will be fabricated by a qualified dentist. The mouthguard will be worn during sleep for 6 weeks. Participants will be instructed to clean the mouthguard daily and to store it in a cool, dry place. | Device | Mouthguard Only |
Primary outcome
Change in Masseter Muscle Activity and Cervical Posture Angle from Baseline to 6 Weeks Measured by Surface EMG and Postural Assessment Tools.
Time frame: From enrollment to the end of treatment at 6weeks
Surface electromyography (sEMG) will be used to measure muscle activity of the masseter and temporalis during rest and clenching. A posture assessment tool will evaluate changes in head and cervical posture using digital angle measurements. Measurements will be taken at baseline and after 6 weeks of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Background: PubMed 19264033Barros Vde M, Seraidarian PI, Cortes MI, de Paula LV. The impact of orofacial pain on the quality of life of patients with temporomandibular disorder. J Orofac Pain. 2009 Winter;23(1):28-37.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouthguard and Physiotherapy and Mouthguard Only in people with Bruxism and Manual Theapy, run by Saint-Joseph University at 1 site in Lebanon.
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 5 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: finished, as of the sponsor's last update on 4 Jul 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 Lebanon. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Masseter Muscle Activity and Cervical Posture Angle from Baseline to 6 Weeks Measured by Surface EMG and Postural Assessment Tools. (time frame: From enrollment to the end of treatment at 6weeks). 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 NCT07051876, 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 4 Jul 2025.