Temporomandibular DisordersNCT07626164
Three Photobiomodulation Wavelengths (635, 940, and 1064 nm) on Chronic Myogenic Temporomandibular Disorder
A study testing 635 nm red diode laser, 940 nm NIR diode laser (Biolase) and 1064 nm Nd:YAG laser (Fotona) in people with Temporomandibular Disorders, run by Alexandria University at 1 site in Egypt.
Trial summary
Temporomandibular disorders (TMDs) are among the most common musculoskeletal conditions associated with chronic orofacial pain and functional disability. Chronic Myogenic TMD (MTMD) is the most prevalent subtype and is characterized by persistent masticatory muscle pain driven by peripheral and central sensitization… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- 635 nm red diode laser, 940 nm NIR diode laser (Biolase) and 1064 nm Nd:YAG laser (Fotona)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 30 Dec 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients suffering from chronic myogenic TMD based on diagnostic criteria for diagnosis of temporomandibular joint disorders (DC/TMD) criteria. (pain increases with jaw opening, chewing, or clenching).
- Patients suffering of unilateral or bilateral chronic pain (> 3 months' duration) related to masseter and temporalis muscles(30).
- Patients suffering of moderate-to-severe pain intensity ≥ 4 on a 0-10 VAS
- Patients that have not responded to conservative modes of treatment during the study and up to 3 months after last intervention. (medications, physiotherapy, splints).
Who cannot join
- Patients suffering from chronic systematic conditions that alter pain sensitivity; neurological diseases, pain of dental origin, pregnancy or lactation, high blood pressure, diabetes milletus, rheumatic inflammatory disease, fibromyalgia, obstructive sleep apnea, and restrictions for the use of laser (pacemakers).
- Participants on medications that affect pain sensitivity and perception during the last 2 weeks: anticoagulants, analgesics, or antidepressants.
- History of surgery, arthropathy (joint disorders), facial trauma, malignant tumors or fractures in the orofacial region, neuropsychological or hormonal problems
- Treatments: orthodontics, splints, major occlusal rehabilitation, prosthodontic therapy, previous PBM, TENS therapy, or botox for TMD in the last 6 months.
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
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria
Faculty of Dentistry, (203) 4868308
Ahmed Shafik, BDS
About this study
Official title: Efficacy of Three Photobiomodulation Wavelengths (635, 940, and 1064 nm) on Chronic Myogenic Temporomandibular Disorder A Randomized Clinical Trial
Temporomandibular disorders (TMDs) are among the most common musculoskeletal conditions associated with chronic orofacial pain and functional disability. Chronic Myogenic TMD (MTMD) is the most prevalent subtype and is characterized by persistent masticatory muscle pain driven by peripheral and central sensitization mechanisms. Photobiomodulation (PBM) represents a conservative, non-invasive therapeutic modality within the medical management of TMD; however, the wavelength-dependent clinical and muscular effects remain inadequately defined. Aim: To compare the efficacy of three PBM wavelengths (635, 940, 1,064 nm) on pain intensity, mandibular function, surface electromyographic activity (sEMG), and pressure pain threshold (PPT) in patients with chronic myogenic TMD.
- Conditions
- Temporomandibular Disorders
- Being tested
- 635 nm red diode laser, 940 nm NIR diode laser (Biolase), 1064 nm Nd:YAG laser (Fotona)
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
635 nm red diode laserOther
Participants will receive PBM therapy using a 635 nm red diode laser (Lasotronix), standardized at a fluence of 8 J/cm² for energy density and Irradiance of 0.50 W/cm² power density in continuous wave using PBM applicator (8mm tip) for 16 seconds, near-contact working distance.
940 nm NIR diode laser (Biolase)Other
Participants will receive PBM therapy using a 940 nm NIR diode laser (Biolase), standardized at a fluence of 8 J/cm² and Irradiance of 0.63 W/cm² power density in continuous wave using deep tissue handpiece (10mm tip) for 12.8 seconds.
1064 nm Nd:YAG laser (Fotona)Other
Participants will receive PBM therapy using a 1064 nm Nd:YAG laser (Fotona), standardized at a fluence of 8 J/cm² energy density and Irradiance 0.53 W/cm² power density, using a genova handpiece (11mm tip) stamping technique for 15.2 sec.
| Study group | Role | What they receive |
|---|---|---|
| PBM therapy I | Experimental | Not described Receives: Other: 635 nm red diode laser |
| PBM therapy II | Experimental | Not described Receives: Other: 940 nm NIR diode laser (Biolase) |
| PBM therapy III | Experimental | Not described Receives: Other: 1064 nm Nd:YAG laser (Fotona) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subjective Pain Intensity
It will be assessed using both visual analog scale (VAS) at baseline, 7,14,21 days, and 4, 12 weeks
Measured: up to 12 weeks
Secondary outcomes (4)
Change in maximum mouth opening
Functional maximum mouth opening (MMO) unassisted and in the pain-free opening range (PFO) by digital caliper at baseline, 7,14,21 days, and 4, 12 weeks.
Measured: up to 12 weeks
Change in muscles activity
Surface electromyography (sEMG) activity during rest and maximum voluntary clenching (MVC) activity using surface electrodes
Measured: up to 12 weeks
Change in Number of tender points
by palpation pressure of muscles
Measured: up to 12 weeks
Change in pressure pain threshold
Pressure pain threshold (PPT) over the most tender point of the masseter and temporalis muscles by a pressure algometer (PA) to measure the degree of tenderness over the most tender points at the muscles
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 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
- NCT07626164
- Sponsor's protocol ID
- 1320 - 04 / 2026
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 4 Jun 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Three Photobiomodulation Wavelengths (635, 940, and 1064 nm) on Chronic Myogenic Temporomandibular Disorder A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07626164
- Acronym / sponsor ID
- 1320 - 04 / 2026
- Conditions
- Temporomandibular Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Jun 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 disorders (TMDs) are among the most common musculoskeletal conditions associated with chronic orofacial pain and functional disability. Chronic Myogenic TMD (MTMD) is the most prevalent subtype and is characterized by persistent masticatory muscle pain driven by peripheral and central sensitization mechanisms. Photobiomodulation (PBM) represents a conservative, non-invasive therapeutic modality within the medical management of TMD; however, the wavelength-dependent clinical and muscular effects remain inadequately defined. Aim: To compare the efficacy of three PBM wavelengths (635, 940, 1,064 nm) on pain intensity, mandibular function, surface electromyographic activity (sEMG), and pressure pain threshold (PPT) in patients with chronic myogenic TMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PBM therapy I | Experimental | Other: 635 nm red diode laser |
| PBM therapy II | Experimental | Other: 940 nm NIR diode laser (Biolase) |
| PBM therapy III | Experimental | Other: 1064 nm Nd:YAG laser (Fotona) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients suffering from chronic myogenic TMD based on diagnostic criteria for diagnosis of temporomandibular joint disorders (DC/TMD) criteria. (pain increases with jaw opening, chewing, or clenching).
- Patients suffering of unilateral or bilateral chronic pain (> 3 months' duration) related to masseter and temporalis muscles(30).
- Patients suffering of moderate-to-severe pain intensity ≥ 4 on a 0-10 VAS
- Patients that have not responded to conservative modes of treatment during the study and up to 3 months after last intervention. (medications, physiotherapy, splints).
Key exclusion criteria (4 listed)
- Patients suffering from chronic systematic conditions that alter pain sensitivity; neurological diseases, pain of dental origin, pregnancy or lactation, high blood pressure, diabetes milletus, rheumatic inflammatory disease, fibromyalgia, obstructive sleep apnea, and restrictions for the use of laser (pacemakers).
- Participants on medications that affect pain sensitivity and perception during the last 2 weeks: anticoagulants, analgesics, or antidepressants.
- History of surgery, arthropathy (joint disorders), facial trauma, malignant tumors or fractures in the orofacial region, neuropsychological or hormonal problems
- Treatments: orthodontics, splints, major occlusal rehabilitation, prosthodontic therapy, previous PBM, TENS therapy, or botox for TMD in the last 6 months.
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 |
|---|---|---|
| 635 nm red diode laserParticipants will receive PBM therapy using a 635 nm red diode laser (Lasotronix), standardized at a fluence of 8 J/cm² for energy density and Irradiance of 0.50 W/cm² power density in continuous wave using PBM applicator (8mm tip) for 16 seconds, near-contact working distance. | Other | PBM therapy I |
| 940 nm NIR diode laser (Biolase)Participants will receive PBM therapy using a 940 nm NIR diode laser (Biolase), standardized at a fluence of 8 J/cm² and Irradiance of 0.63 W/cm² power density in continuous wave using deep tissue handpiece (10mm tip) for 12.8 seconds. | Other | PBM therapy II |
| 1064 nm Nd:YAG laser (Fotona)Participants will receive PBM therapy using a 1064 nm Nd:YAG laser (Fotona), standardized at a fluence of 8 J/cm² energy density and Irradiance 0.53 W/cm² power density, using a genova handpiece (11mm tip) stamping technique for 15.2 sec. | Other | PBM therapy III |
Primary outcome
Change in subjective Pain Intensity
Time frame: up to 12 weeks
It will be assessed using both visual analog scale (VAS) at baseline, 7,14,21 days, and 4, 12 weeks
4 secondary outcomes
Change in maximum mouth opening
Time frame: up to 12 weeks
Change in muscles activity
Time frame: up to 12 weeks
Change in Number of tender points
Time frame: up to 12 weeks
Change in pressure pain threshold
Time frame: up to 12 weeks
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 4 Jun 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 635 nm red diode laser, 940 nm NIR diode laser (Biolase) and 1064 nm Nd:YAG laser (Fotona) in people with Temporomandibular Disorders, 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 4 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: opening soon, as of the sponsor's last update on 4 Jun 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 Ahmed Shafik, BDS (01275607044 ext. 002, safwat4dental@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subjective Pain Intensity (time frame: up to 12 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 4 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.