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| ID | Type | Description | Link |
|---|---|---|---|
| TMD-NILES-STUDY-LASER-TRIAL-20 | Other Identifier | NILES, Cairo University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doctor smile 635nm For Arm 1 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline). |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline). |
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Inclusion Criteria:
Exclusion Criteria:
"Eligible for both male and female participants
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| Name | Affiliation | Role |
|---|---|---|
| hala SH Attiyah, BDS | National Institute of Laser Enhanced Sciences (NILES), Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute for Laser Enhanced Sciences | Cairo | Cairo Governorate | 11562 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41039333 | Derived | 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Low-Level Laser Therapy at 635 nm for Arm 1 | 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. Doctor smile 635nm For Arm 1: 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. |
| FG001 | Low-Level Laser Therapy at 980 nm for Arm 2 | 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. Doctor smile 980 nm For Arm2: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All randomized participants (15 in each group) were included in the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Low-Level Laser Therapy at 635 nm for Arm 1 | Participants received low-level laser therapy using a diode laser with a 635 nm wavelength. Treatment was applied twice weekly for five weeks to the masticatory muscles affected by myofascial pain syndrome in the temporomandibular joint region, aiming to reduce pain and improve muscle function. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | "Participant age range at baseline was 18 to 50 years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | "All randomized participants in each arm (15 participants per group) were included in the analysis population. Analyses were conducted according to the intention-to-treat principle, including all participants who received at least one session of low-level laser therapy and had at least one post-baseline assessment." | Posted | Mean | Standard Deviation | "units on scale | At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline). |
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"Adverse event data were collected from baseline, throughout the 5-week treatment period, and at the 1-month follow-up visit."
"The standard definitions of adverse events and serious adverse events, as provided by ClinicalTrials.gov, were used. Data were collected systematically through patient self-reports and clinical observations during treatment sessions and at the follow-up visit."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-Level Laser Therapy at 635 nm for Arm 1 | Participants received photobiomodulation therapy using a diode laser at a wavelength of 635 nm. Treatment was applied twice per week for 5 weeks to the masseter and temporalis muscles associated with temporomandibular disorder. The goal was to reduce myofascial pain and improve mandibular function. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| No adverse events reported | Eye disorders | No formal source voc | Systematic Assessment | "No ocular adverse effects reported due to the use of protective eye goggles during laser therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| None reported | General disorders | MedDRA, Version 27.1 | Systematic Assessment | No adverse events or side effects were observed or reported by participants during or after the low-level laser therapy treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR.hala shaaban attiyah | National Institute of Laser Enhanced Sciences (NILES), Cairo University | 01012894478 | std.halashaaban@niles.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2024 | Aug 20, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2025 | Aug 20, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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"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."
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"This is an open-label study with no masking; both participants and investigators are aware of the treatment assignments."
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| Doctor smile 980 nm For Arm2 | Device | 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. |
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| 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. | 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. | 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. | At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline). |
| BG001 |
| Low-Level Laser Therapy at 980 nm for Arm 2 |
Participants received 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. Doctor smile 980 nm For Arm2: 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex/Gender, Customized | Distribution of participants by sex at baseline. | Count of Participants | Participants |
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| Race (NIH/OMB) | Distribution of participants by race/ethnicity was assessed at baseline according to NIH/OMB standard categories. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Distribution of participants by race/ethnicity was assessed at baseline according to NIH/OMB standard categories. | Count of Participants | Participants |
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| Low-Level Laser Therapy at 635 nm for Arm 1 |
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. Doctor smile 635nm For Arm 1: 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. |
| OG001 | Low-Level Laser Therapy at 980 nm for Arm 2 | 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. Doctor smile 980 nm For Arm2: 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. |
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| Secondary | 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." | "All randomized participants in each arm (15 participants per group) were included in the analysis population. Analyses were conducted according to the intention-to-treat principle, including all participants who received at least one session of low-level laser therapy and had at least one post-baseline assessment." | Posted | Mean | Standard Deviation | millimeters | At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline). |
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| Secondary | 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. | All randomized participants completed the study and were included in the analysis for this outcome measure. | Posted | Mean | Standard Deviation | millimeters | At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline). |
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| Secondary | 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. | sEMG analysis includes participants with valid baseline and post-treatment data. Differences in numbers are due to technical issues, poor signal quality, or withdrawals. Variations in sample size reflect missing data for some muscles or time points | Posted | Mean | Standard Deviation | microvolts | At baseline and after 10 treatment sessions (5 weeks) |
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| Secondary | 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. | randomized participants who completed the study protocol were included in the analysis. No participants were excluded from the outcome measure analysis." | Posted | Mean | Standard Deviation | millimeters | At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline). |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Low-Level Laser Therapy at 980 nm for Arm 2 | Participants received photobiomodulation therapy using a diode laser at a wavelength of 980 nm. Treatment was applied twice per week for 5 weeks to the masseter and temporalis muscles associated with temporomandibular disorder. The goal was to reduce myofascial pain and improve mandibular function. | 0 | 15 | 0 | 15 | 0 | 15 |
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| follow up after 1 month |
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| follow up after one month |
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| Left temporalis M before treatment |
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| Left temporalis M after 10 sessions |
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| Right masster M before treatment |
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| Right masseter M after 10 sessions |
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| Left masseter M before treatment |
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| Left masseter M after 10 sessions |
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| follow up after one month |
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