Myofascial Pain SyndromeLLLTsEMGNCT07069764
Efficacy of Photobiomodulation Therapy Using 980nm Versus 635nm Diode Lasers for Treatment of Myofascial Pain
A study testing Doctor smile 635nm For Arm 1 and Doctor smile 980 nm For Arm2 in people with Myofascial Pain Syndrome, run by National Institute of Laser Enhanced Sciences at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to evaluate the efficacy of low-level laser therapy (LLLT) using two different diode laser wavelengths (980 nm and 635 nm) in the treatment of myofascial pain associated with temporomandibular disorders (TMD). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Doctor smile 635nm For Arm 1 and Doctor smile 980 nm For Arm2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 29 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - patients with myofascial pain due to stress, medically free, not to resort to self-medication during the study period with no chronic diseases.
Who cannot join
- Patients with TMJ disorders either due to bony degeneration changes or soft tissue changes.
- Patients with pain of dental etiology were excluded, pregnancy, lactation, cardiac arrhythmia, diabetic patients, erosions and medically free.
- Patient with history of malignancy or a history of previous surgery of neck and/ shoulder within the past year of the study were excluded.
- Any patients had treatment that can affect muscles will be excluded, either pharmacological treatment (e.g, opioids, morphine, muscles relaxants or anti-depressants), physiotherapy management and occlusal splints.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
National Institute for Laser Enhanced Sciences
Cairo, Cairo Governorate, 11562
About this study
This randomized controlled clinical trial aims to evaluate the efficacy of low-level laser therapy (LLLT) using two different diode laser wavelengths (980 nm and 635 nm) in the treatment of myofascial pain associated with temporomandibular disorders (TMD). The study compares pain reduction and muscle activity improvement using surface electromyography (sEMG) before and after laser application. Participants are randomly assigned to receive either 980 nm or 635 nm laser treatment twice per week for five weeks. The primary outcomes include pain intensity and functional mandibular movements, while secondary outcomes assess changes in sEMG recordings.
Read the detailed description
This randomized controlled clinical trial investigates the effectiveness of low-level laser therapy (LLLT) using two diode laser wavelengths-980 nm and 635 nm-for the treatment of myofascial pain syndrome (MPS) in patients with temporomandibular disorders (TMD). The study is conducted at the National Institute of Laser Enhanced Sciences (NILES), Cairo University.
Participants who meet the inclusion criteria are randomly assigned to two intervention groups. Group 1 receives LLLT using a 635 nm diode laser, while Group 2 receives LLLT using a 980 nm diode laser. Both groups undergo treatment twice per week for a total of five weeks, following a standardized protocol.
The primary outcomes include pain intensity assessed using a visual analog scale (VAS), and evaluation of mandibular range of motion including lateral and protrusive movements. Secondary outcomes involve the assessment of masseter and temporalis muscle activity using surface electromyography (sEMG) before and after the treatment period.
The study aims to provide evidence-based comparison between the two wavelengths in terms of pain reduction and neuromuscular improvement, contributing to the optimization of non-invasive laser protocols for TMD-related myofascial pain.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Doctor smile 635nm For Arm 1, Doctor smile 980 nm For Arm2
- Keywords
- Low-Level Laser Therapy
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doctor smile 635nm For Arm 1Device
Also called device_LLLT
Participants will receive low-level laser therapy using a diode laser with a wavelength of 635 nanometers. The treatment will be applied twice weekly for five weeks to the affected temporomandibular joint muscles to reduce myofascial pain and improve muscle function.
Doctor smile 980 nm For Arm2Device
Also called device _LLLT
Participants will receive low-level laser therapy using a diode laser with a wavelength of 980 nanometers. The treatment will be applied twice weekly for five weeks to the affected temporomandibular joint muscles to reduce myofascial pain and improve muscle function.
| Study group | Role | What they receive |
|---|---|---|
| Low-Level Laser Therapy at 635 nm for Arm 1 | Experimental | Participants will receive low-level laser therapy using a diode laser with 635 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint. Receives: Device: Doctor smile 635nm For Arm 1 |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Experimental | Participants will receive low-level laser therapy using a diode laser with 980 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint. Receives: Device: Doctor smile 980 nm For Arm2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Reduction
"Pain intensity was assessed in patients with myofascial pain syndrome of the temporomandibular joint using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Measurements were recorded at baseline, after 10 sessions of low-level laser therapy (5 weeks), and at 1-month follow-up. Data are reported in the tables below. Lower scores reflect reduced pain intensity
Measured: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
Secondary outcomes (4)
Maximum Mouth Opening (MMO)
"Maximum Mouth Opening (MMO) was assessed in millimeters at three time points: baseline, after 10 sessions of low-level laser therapy (5 weeks), and at 1-month follow-up. Data are reported as mean ± standard deviation in the tables below. No conclusions or comparisons are included in this description."
Measured: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
Lateral Jaw Movements
Lateral jaw movements (side-to-side excursion) were measured in millimeters to assess changes in temporomandibular joint function. Measurements were recorded at baseline, after 10 sessions of low-level laser therapy (5 weeks), and at 1-month follow-up. Higher values indicate a greater range of mandibular motion.
Measured: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
Changes in Muscle Activity Measured by Surface Electromyography (sEMG)
Surface electromyography (sEMG) was used to assess the electrical activity of the masseter and anterior temporalis muscles during maximum voluntary clenching. Recordings were obtained at baseline and after 10 sessions of low-level laser therapy (5 weeks). Results are expressed as mean amplitude values in microvolts (µV). Lower values indicate reduced muscle activity, which reflects clinical improvement.
Measured: At baseline and after 10 treatment sessions (5 weeks)
Protrusive Movements
Protrusive mandibular movements were measured in millimeters to evaluate the functional improvement of the temporomandibular joint. Measurements were taken at baseline, after 5 weeks of low-level laser therapy, and at 1-month follow-up. Higher values indicate greater range of mandibular protrusive motion.
Measured: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Aug 2024
- Primary completion29 Mar 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromeStudies 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
- Model description
- "Randomized controlled trial with two parallel groups comparing the effect of low-level diode laser therapy at 980 nm and 635 nm wavelengths on myofascial pain in temporomandibular disorders. Participants receive treatment sessions over a defined period with outcomes measured by surface electromyography and pain scales."
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Laser Enhanced Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hala Shaaban, National Institute of Laser Enhanced Sciences
- Investigators
- hala SH Attiyah, BDS, Principal investigator, National Institute of Laser Enhanced Sciences (NILES), Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069764
- Sponsor's protocol ID
- NILES-TMD-LLLT-2024
- Other IDs
- TMD-NILES-STUDY-LASER-TRIAL-20
- Acronym
- LLLTsEMG
- Status last verified
- Sep 2025
- First submitted
- 7 Jul 2025
- Last updated
- 23 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the data will be used only within the study team for internal analysis, and no external data sharing is planned.
Publications
Attiyah HS, Moharrum HS, El Dakrory UAERM. Efficacy of photobiomodulation therapy using 980 nm versus 635 nm diode lasers for treatment of myofascial pain : a randomized controlled trial. BMC Oral Health. 2025 Oct 2;25(1):1511. doi: 10.1186/s12903-025-06971-7.
PubMed 41039333
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Photobiomodulation Therapy Using 980nm Versus 635nm Diode Lasers for Treatment of Myofascial Pain
- ClinicalTrials.gov ID
- NCT07069764
- Acronym / sponsor ID
- LLLTsEMG / NILES-TMD-LLLT-2024
- Conditions
- Myofascial Pain Syndrome
- Keywords
- Low-Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute of Laser Enhanced SciencesUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 29 Mar 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 17 Jul 2025 (actual)
- Results
- Posted 23 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled clinical trial aims to evaluate the efficacy of low-level laser therapy (LLLT) using two different diode laser wavelengths (980 nm and 635 nm) in the treatment of myofascial pain associated with temporomandibular disorders (TMD). The study compares pain reduction and muscle activity improvement using surface electromyography (sEMG) before and after laser application. Participants are randomly assigned to receive either 980 nm or 635 nm laser treatment twice per week for five weeks. The primary outcomes include pain intensity and functional mandibular movements, while secondary outcomes assess changes in sEMG recordings.
Detailed description
This randomized controlled clinical trial investigates the effectiveness of low-level laser therapy (LLLT) using two diode laser wavelengths-980 nm and 635 nm-for the treatment of myofascial pain syndrome (MPS) in patients with temporomandibular disorders (TMD). The study is conducted at the National Institute of Laser Enhanced Sciences (NILES), Cairo University.
Participants who meet the inclusion criteria are randomly assigned to two intervention groups. Group 1 receives LLLT using a 635 nm diode laser, while Group 2 receives LLLT using a 980 nm diode laser. Both groups undergo treatment twice per week for a total of five weeks, following a standardized protocol.
The primary outcomes include pain intensity assessed using a visual analog scale (VAS), and evaluation of mandibular range of motion including lateral and protrusive movements. Secondary outcomes involve the assessment of masseter and temporalis muscle activity using surface electromyography (sEMG) before and after the treatment period.
The study aims to provide evidence-based comparison between the two wavelengths in terms of pain reduction and neuromuscular improvement, contributing to the optimization of non-invasive laser protocols for TMD-related myofascial pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- "Randomized controlled trial with two parallel groups comparing the effect of low-level diode laser therapy at 980 nm and 635 nm wavelengths on myofascial pain in temporomandibular disorders. Participants receive treatment sessions over a defined period with outcomes measured by surface electromyography and pain scales."
| Arm | Type | Receives |
|---|---|---|
| Low-Level Laser Therapy at 635 nm for Arm 1 | Experimental | Device: Doctor smile 635nm For Arm 1Participants will receive low-level laser therapy using a diode laser with 635 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint. |
| Low-Level Laser Therapy at 980 nm for Arm 2 | Experimental | Device: Doctor smile 980 nm For Arm2Participants will receive low-level laser therapy using a diode laser with 980 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- - patients with myofascial pain due to stress, medically free, not to resort to self-medication during the study period with no chronic diseases.
Key exclusion criteria (4 listed)
- Patients with TMJ disorders either due to bony degeneration changes or soft tissue changes.
- Patients with pain of dental etiology were excluded, pregnancy, lactation, cardiac arrhythmia, diabetic patients, erosions and medically free.
- Patient with history of malignancy or a history of previous surgery of neck and/ shoulder within the past year of the study were excluded.
- Any patients had treatment that can affect muscles will be excluded, either pharmacological treatment (e.g, opioids, morphine, muscles relaxants or anti-depressants), physiotherapy management and occlusal splints.
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 |
|---|---|---|
| Doctor smile 635nm For Arm 1Also: device_LLLTParticipants will receive low-level laser therapy using a diode laser with a wavelength of 635 nanometers. The treatment will be applied twice weekly for five weeks to the affected temporomandibular joint muscles to reduce myofascial pain and improve muscle function. | Device | Low-Level Laser Therapy at 635 nm for Arm 1 |
| Doctor smile 980 nm For Arm2Also: device _LLLTParticipants will receive low-level laser therapy using a diode laser with a wavelength of 980 nanometers. The treatment will be applied twice weekly for five weeks to the affected temporomandibular joint muscles to reduce myofascial pain and improve muscle function. | Device | Low-Level Laser Therapy at 980 nm for Arm 2 |
Primary outcome
Pain Intensity Reduction
Time frame: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
"Pain intensity was assessed in patients with myofascial pain syndrome of the temporomandibular joint using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Measurements were recorded at baseline, after 10 sessions of low-level laser therapy (5 weeks), and at 1-month follow-up. Data are reported in the tables below. Lower scores reflect reduced pain intensity
4 secondary outcomes
Maximum Mouth Opening (MMO)
Time frame: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
Lateral Jaw Movements
Time frame: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
Changes in Muscle Activity Measured by Surface Electromyography (sEMG)
Time frame: At baseline and after 10 treatment sessions (5 weeks)
Protrusive Movements
Time frame: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41039333Attiyah HS, Moharrum HS, El Dakrory UAERM. Efficacy of photobiomodulation therapy using 980 nm versus 635 nm diode lasers for treatment of myofascial pain : a randomized controlled trial. BMC Oral Health. 2025 Oct 2;25(1):1511. doi: 10.1186/s12903-025-06971-7.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the data will be used only within the study team for internal analysis, and no external data sharing is planned.
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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.
hala SH Attiyah, BDS principal investigator
National Institute of Laser Enhanced Sciences (NILES), Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doctor smile 635nm For Arm 1 and Doctor smile 980 nm For Arm2 in people with Myofascial Pain Syndrome, run by National Institute of Laser Enhanced Sciences 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 1 inclusion and 4 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 23 Oct 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?
Yes. Results are posted in the registry (first posted 23 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Intensity Reduction (time frame: At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).). 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 NCT07069764, 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 Oct 2025.