TMJNCT07800338
Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus Therapeutic Ultrasound On Patients With Myofascial Pain Disorder : A Randomized Clinical Trial
A study testing Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain Disorder in people with TMJ, run by Cairo University.
Trial summary
Myofascial pain dysfunction (MPD) is one of the most common causes of chronic orofacial pain, primarily affecting the masticatory muscles such as the masseter and temporalis. It leads to facial pain, muscle tenderness, and restricted mouth opening, significantly impacting patients' quality of life and daily function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TMJ
- What is being tested?
- Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain Disorder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Feb 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients should have one or more signs and symptoms of these
- Symptoms: Patients who report typical symptoms of myofascial pain , such as pain, discomfort, especially when opening or closing the mouth.
- Mouth Opening: Limited range of motion or difficulty with full mouth opening.
- Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.
- Patients who will be free from any systemic diseases that affect temporomandibular joint.
- Patients who will be ready to give informed consent.
Who cannot join
- Blood dyscrasias and systemtic diseases.
- Previous surgery of the affected joint.
- Infection
- Patients with previous facial fracture.
- Patients who will be under another type of treatment for TMD (e.g., occlusal splints, pharmacological drugs, or head and neck surgery).
- Patients who will not attend the proposed treatment sessions or follow-up visits.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Myofascial pain dysfunction (MPD) is one of the most common causes of chronic orofacial pain, primarily affecting the masticatory muscles such as the masseter and temporalis. It leads to facial pain, muscle tenderness, and restricted mouth opening, significantly impacting patients' quality of life and daily function.
Despite the wide range of conservative treatment modalities-such as medications, splint therapy, and physiotherapy-there is still no universally accepted approach that provides consistent and long-lasting relief.
Read more
Low-level laser therapy (LLLT) and therapeutic ultrasound (US) are two non-invasive physical modalities frequently used in dentistry for pain control and tissue healing. Each has shown promising outcomes individually.
Azizi et al. (2007) demonstrated that LLLT at 780 nm can significantly reduce pain and tenderness for up to three months, while Khairy (2018) reported notable pain relief and improved jaw function using pulsed ultrasound at 1.5 W/cm² for 5 minutes over 10 sessions.
However, direct comparative evidence between LLLT and therapeutic ultrasound in patients with myofascial pain dysfunction is still lacking.
This knowledge gap prevents clinicians from identifying which modality offers superior short- and long-term outcomes in terms of pain reduction, muscle function improvement, and patient satisfaction.
Therefore, this study aims to compare the efficacy of low-level laser therapy versus therapeutic ultrasound in the management of myofascial pain dysfunction, using standardized treatment parameters from the most evidence-based protocols in the literature.
Read the detailed description
Myofascial pain dysfunction (MPD) is one of the most common causes of chronic orofacial pain, typically involving the masticatory muscles such as the masseter and temporalis. It is characterized by localized muscle tenderness, trigger points, and functional limitation of jaw movements. The condition affects a significant percentage of adults and can lead to persistent discomfort and impaired quality of life.
The etiology of MPD is multifactorial, including parafunctional habits such as bruxism, psychological stress, trauma, malocclusion, and muscle overuse. Because of this complex etiology, management often requires a multimodal approach combining behavioral, pharmacological, and physical therapies.
- Myofascial Pain and Physical Modalities
Conservative physical modalities are widely used as first-line treatments for MPD because they are non-invasive, safe, and easily applicable. These modalities include ultrasound therapy, low-level laser therapy, transcutaneous electrical nerve stimulation (TENS), and thermotherapy. Among these, therapeutic ultrasound (US) and low-level laser therapy (LLLT) have gained increasing attention for their effectiveness in pain reduction and tissue healing without pharmacological side effects.
- Low-Level Laser Therapy (LLLT)
Low-level laser therapy, also referred to as photobiomodulation therapy, uses light energy at specific wavelengths to produce photochemical and photothermal effects in tissues. These effects lead to enhanced cellular metabolism, increased microcirculation, improved oxygen supply, and stimulation of ATP production, which collectively accelerate healing and reduce inflammation.
Several studies have explored the role of LLLT in treating myofascial pain dysfunction.
Azizi et al. (2007) evaluated the effect of LLLT (780 nm, 10 mW) applied to the masseter, temporalis, medial, and lateral pterygoid muscles. Each region received 1200 mJ of energy per session, with twelve sessions performed over four weeks. The study demonstrated a significant reduction in pain and muscle tenderness and an improvement in mandibular function. Importantly, these therapeutic effects persisted up to three months after the completion of treatment, indicating both short-term and long-term efficacy.
Other research supports these findings, confirming that LLLT promotes analgesia by modulating nerve conduction velocity, reducing bradykinin and histamine release, and stimulating mitochondrial cytochrome oxidase activity. The cumulative evidence suggests that LLLT provides a safe, effective, and sustainable method for managing myofascial pain.
- Therapeutic Ultrasound (US)
Therapeutic ultrasound is a commonly used modality in physiotherapy and dentistry. It transmits acoustic energy through tissues, producing both thermal and mechanical effects. These effects enhance blood flow, increase cell membrane permeability, and promote tissue repair while reducing muscle spasm and pain.
Khairy (2018) conducted a randomized clinical study comparing phonophoresis and ultrasound therapy in myofascial pain dysfunction syndrome. The study applied pulsed ultrasound at 1.5 W/cm² for 5 minutes per session, over ten sessions spanning three weeks. The ultrasound head was moved in circular motions across the affected masseter muscle using coupling gel.
Results showed significant improvements in pain intensity (VAS), maximum mouth opening (MMO), and muscle tenderness compared with baseline values. This confirms the beneficial role of pulsed ultrasound in decreasing pain and improving masticatory muscle function.
The therapeutic benefits of ultrasound are attributed to its mechanical micro-massage effect, which enhances cellular exchange, reduces edema, and improves local metabolism. The pulsed mode, in particular, minimizes thermal buildup and focuses on non-thermal biostimulation, making it suitable for inflamed or tender tissues such as the masseter.
- Comparison between LLLT and Ultrasound Therapy
Both LLLT and ultrasound therapy share common goals-reducing pain, decreasing muscle stiffness, and improving jaw function-but act through different biophysical mechanisms. LLLT works primarily through photochemical cellular activation, while ultrasound acts via mechanical micro-vibration and mild thermal stimulation.
Although both modalities have been proven individually effective, few studies have directly compared their outcomes in myofascial pain dysfunction.
Combining evidence from Azizi (2007) and Khairy (2018) indicates that both approaches are effective within short treatment durations (3-4 weeks) and produce measurable improvements in pain and muscle performance. However, the relative superiority of one modality over the other remains undetermined, justifying the need for a direct head-to-head comparison using standardized settings.
- Conditions
- TMJ
- Being tested
- Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain DisorderDevice
Given that both modalities promote pain relief and muscle recovery through distinct biological pathways-LLLT via photobiomodulation and US via mechanical and thermal stimulation-a direct comparison between them can determine which produces superior clinical outcomes in terms of pain reduction, functional improvement, and duration of therapeutic effect.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation The Effect Of Low-Level Laser Therapy On Masseter Muscle On Patients With Myofascial Pain | Experimental | Low-Level Laser Therapy (LLLT) utilizes light energy, typically in the red or near-infrared spectrum (630-830 nm), to stimulate photochemical reactions in the target tissues. The absorbed photons enhance mitochondrial activity, increase ATP production, improve local blood circulation, and reduce inflammatory mediators such as prostaglandins and bradykinin. These actions contribute to analgesia, relaxation of muscle fibers, and acceleration of tissue repair.
In the study by Azizi et al. (2007), LLLT at 780 nm with a total energy of 1200 mJ per treated region significantly reduced pain and muscle tenderness, and these imp Receives: Device: Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain Disorder |
| Evaluation Of The Effect Of therapeutic Ultrasound On Patients With Myofascial Pain Disorder | Experimental | Therapeutic Ultrasound (US), on the other hand, transmits mechanical acoustic energy through soft tissues, producing micro-vibration and mild thermal effects. These effects increase cellular permeability, stimulate fibroblast activity, enhance microcirculation, and facilitate the resorption of inflammatory exudates. The pulsed mode specifically provides a non-thermal biostimulatory effect, making it suitable for acute or painful conditions.
Khairy (2018) reported that pulsed ultrasound at 1.5 W/cm² for 5 minutes per session over ten sessions produced significant reductions in pain intensity and improvement in mouth opening in patients with myofascial pain dysfunction. Receives: Device: Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
pain severity will be assessed using Visual analogue scale 0-10
Measured: measured at baseline ,1week, 2weeks, 3weeks, 4weeks, 1months,3months, 6months
Secondary outcomes (1)
Maximum interincisal opening
Maximum interincisal opening will be measeured in millimeters using digital caliper
Measured: baseline , 1week, 2weeks,3weeks, 4weeks, 1month,3months, 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed mostafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800338
- Sponsor's protocol ID
- tmj Myofascial Pain Disorder
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus Therapeutic Ultrasound On Patients With Myofascial Pain Disorder : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07800338
- Acronym / sponsor ID
- tmj Myofascial Pain Disorder
- Conditions
- TMJ
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Sep 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.
Myofascial pain dysfunction (MPD) is one of the most common causes of chronic orofacial pain, primarily affecting the masticatory muscles such as the masseter and temporalis. It leads to facial pain, muscle tenderness, and restricted mouth opening, significantly impacting patients' quality of life and daily function.
Despite the wide range of conservative treatment modalities-such as medications, splint therapy, and physiotherapy-there is still no universally accepted approach that provides consistent and long-lasting relief.
Low-level laser therapy (LLLT) and therapeutic ultrasound (US) are two non-invasive physical modalities frequently used in dentistry for pain control and tissue healing. Each has shown promising outcomes individually.
Azizi et al. (2007) demonstrated that LLLT at 780 nm can significantly reduce pain and tenderness for up to three months, while Khairy (2018) reported notable pain relief and improved jaw function using pulsed ultrasound at 1.5 W/cm² for 5 minutes over 10 sessions.
However, direct comparative evidence between LLLT and therapeutic ultrasound in patients with myofascial pain dysfunction is still lacking.
This knowledge gap prevents clinicians from identifying which modality offers superior short- and long-term outcomes in terms of pain reduction, muscle function improvement, and patient satisfaction.
Therefore, this study aims to compare the efficacy of low-level laser therapy versus therapeutic ultrasound in the management of myofascial pain dysfunction, using standardized treatment parameters from the most evidence-based protocols in the literature.
Detailed description
Myofascial pain dysfunction (MPD) is one of the most common causes of chronic orofacial pain, typically involving the masticatory muscles such as the masseter and temporalis. It is characterized by localized muscle tenderness, trigger points, and functional limitation of jaw movements. The condition affects a significant percentage of adults and can lead to persistent discomfort and impaired quality of life.
The etiology of MPD is multifactorial, including parafunctional habits such as bruxism, psychological stress, trauma, malocclusion, and muscle overuse. Because of this complex etiology, management often requires a multimodal approach combining behavioral, pharmacological, and physical therapies.
- Myofascial Pain and Physical Modalities
Conservative physical modalities are widely used as first-line treatments for MPD because they are non-invasive, safe, and easily applicable. These modalities include ultrasound therapy, low-level laser therapy, transcutaneous electrical nerve stimulation (TENS), and thermotherapy. Among these, therapeutic ultrasound (US) and low-level laser therapy (LLLT) have gained increasing attention for their effectiveness in pain reduction and tissue healing without pharmacological side effects.
- Low-Level Laser Therapy (LLLT)
Low-level laser therapy, also referred to as photobiomodulation therapy, uses light energy at specific wavelengths to produce photochemical and photothermal effects in tissues. These effects lead to enhanced cellular metabolism, increased microcirculation, improved oxygen supply, and stimulation of ATP production, which collectively accelerate healing and reduce inflammation.
Several studies have explored the role of LLLT in treating myofascial pain dysfunction.
Azizi et al. (2007) evaluated the effect of LLLT (780 nm, 10 mW) applied to the masseter, temporalis, medial, and lateral pterygoid muscles. Each region received 1200 mJ of energy per session, with twelve sessions performed over four weeks. The study demonstrated a significant reduction in pain and muscle tenderness and an improvement in mandibular function. Importantly, these therapeutic effects persisted up to three months after the completion of treatment, indicating both short-term and long-term efficacy.
Other research supports these findings, confirming that LLLT promotes analgesia by modulating nerve conduction velocity, reducing bradykinin and histamine release, and stimulating mitochondrial cytochrome oxidase activity. The cumulative evidence suggests that LLLT provides a safe, effective, and sustainable method for managing myofascial pain.
- Therapeutic Ultrasound (US)
Therapeutic ultrasound is a commonly used modality in physiotherapy and dentistry. It transmits acoustic energy through tissues, producing both thermal and mechanical effects. These effects enhance blood flow, increase cell membrane permeability, and promote tissue repair while reducing muscle spasm and pain.
Khairy (2018) conducted a randomized clinical study comparing phonophoresis and ultrasound therapy in myofascial pain dysfunction syndrome. The study applied pulsed ultrasound at 1.5 W/cm² for 5 minutes per session, over ten sessions spanning three weeks. The ultrasound head was moved in circular motions across the affected masseter muscle using coupling gel.
Results showed significant improvements in pain intensity (VAS), maximum mouth opening (MMO), and muscle tenderness compared with baseline values. This confirms the beneficial role of pulsed ultrasound in decreasing pain and improving masticatory muscle function.
The therapeutic benefits of ultrasound are attributed to its mechanical micro-massage effect, which enhances cellular exchange, reduces edema, and improves local metabolism. The pulsed mode, in particular, minimizes thermal buildup and focuses on non-thermal biostimulation, making it suitable for inflamed or tender tissues such as the masseter.
- Comparison between LLLT and Ultrasound Therapy
Both LLLT and ultrasound therapy share common goals-reducing pain, decreasing muscle stiffness, and improving jaw function-but act through different biophysical mechanisms. LLLT works primarily through photochemical cellular activation, while ultrasound acts via mechanical micro-vibration and mild thermal stimulation.
Although both modalities have been proven individually effective, few studies have directly compared their outcomes in myofascial pain dysfunction.
Combining evidence from Azizi (2007) and Khairy (2018) indicates that both approaches are effective within short treatment durations (3-4 weeks) and produce measurable improvements in pain and muscle performance. However, the relative superiority of one modality over the other remains undetermined, justifying the need for a direct head-to-head comparison using standardized settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evaluation The Effect Of Low-Level Laser Therapy On Masseter Muscle On Patients With Myofascial Pain | Experimental | Device: Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain DisorderLow-Level Laser Therapy (LLLT) utilizes light energy, typically in the red or near-infrared spectrum (630-830 nm), to stimulate photochemical reactions in the target tissues. The absorbed photons enhance mitochondrial activity, increase ATP production, improve local blood circulation, and reduce inflammatory mediators such as prostaglandins and bradykinin. These actions contribute to analgesia, relaxation of muscle fibers, and acceleration of tissue repair. In the study by Azizi et al. (2007), LLLT at 780 nm with a total energy of 1200 mJ per treated region significantly reduced pain and muscle tenderness, and these imp |
| Evaluation Of The Effect Of therapeutic Ultrasound On Patients With Myofascial Pain Disorder | Experimental | Device: Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain DisorderTherapeutic Ultrasound (US), on the other hand, transmits mechanical acoustic energy through soft tissues, producing micro-vibration and mild thermal effects. These effects increase cellular permeability, stimulate fibroblast activity, enhance microcirculation, and facilitate the resorption of inflammatory exudates. The pulsed mode specifically provides a non-thermal biostimulatory effect, making it suitable for acute or painful conditions. Khairy (2018) reported that pulsed ultrasound at 1.5 W/cm² for 5 minutes per session over ten sessions produced significant reductions in pain intensity and improvement in mouth opening in patients with myofascial pain dysfunction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients should have one or more signs and symptoms of these
- Symptoms: Patients who report typical symptoms of myofascial pain , such as pain, discomfort, especially when opening or closing the mouth.
- Mouth Opening: Limited range of motion or difficulty with full mouth opening.
- Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.
- Patients who will be free from any systemic diseases that affect temporomandibular joint.
Key exclusion criteria (6 listed)
- Blood dyscrasias and systemtic diseases.
- Previous surgery of the affected joint.
- Infection
- Patients with previous facial fracture.
- Patients who will be under another type of treatment for TMD (e.g., occlusal splints, pharmacological drugs, or head and neck surgery).
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 |
|---|---|---|
| Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain DisorderGiven that both modalities promote pain relief and muscle recovery through distinct biological pathways-LLLT via photobiomodulation and US via mechanical and thermal stimulation-a direct comparison between them can determine which produces superior clinical outcomes in terms of pain reduction, functional improvement, and duration of therapeutic effect. | Device | Evaluation Of The Effect Of therapeutic Ultrasound On Patients With Myofascial Pain Disorder, Evaluation The Effect Of Low-Level Laser Therapy On Masseter Muscle On Patients With Myofascial Pain |
Primary outcome
pain
Time frame: measured at baseline ,1week, 2weeks, 3weeks, 4weeks, 1months,3months, 6months
pain severity will be assessed using Visual analogue scale 0-10
1 secondary outcome
Maximum interincisal opening
Time frame: baseline , 1week, 2weeks,3weeks, 4weeks, 1month,3months, 6months
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 2 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain Disorder in people with TMJ, 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 6 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: opening soon, as of the sponsor's last update on 2 Sep 2026. 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?
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 mohamed mostafa dentist, bachelor's degree (01060249544, Mohamed-elsebaie@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: measured at baseline ,1week, 2weeks, 3weeks, 4weeks, 1months,3months, 6months). 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 2 Sep 2026.