Temporomandibular Joint DisordersNCT07878247
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
A study testing Low Level Laser Therapy in people with Temporomandibular Joint Disorders, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Temporomandibular disorders (TMDs) cause pain and dysfunction in the masticatory system, often managed with occlusal splint therapy. However, splint therapy alone may yield inconsistent results. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 10 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who had a Diagnosis of TMD, with chronic pain, muscle spasms, myofascial pain syndrome lasts at least 3 months, and challenges while chewing
- Patients who have Bruxism
Who cannot join
- Patients with a history of trauma, fracture, or surgery involving the temporomandibular joint.
- Presence of systemic or neuromuscular diseases (e.g., rheumatoid arthritis, fibromyalgia, Parkinson's disease).
- Ongoing orthodontic treatment or recent prosthodontic rehabilitation affecting occlusion.
- Use of analgesics, muscle relaxants, or anti-inflammatory drugs within two weeks before the study.
- Pregnant or lactating women.
- Poor compliance or inability to attend follow-up visits.
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, 1 recruiting
- Recruiting
Future University in Egypt (FUE)
Cairo
Waleed Fathy Ali Esmael, M.D, +201006614712, Waleed.Fathy@fue.edu.eg
About this study
Official title: Clinical and Electromyographic Assessment of Occlusal Splint Therapy With and Without Low-Level Laser in Temporomandibular Disorders
Temporomandibular disorders (TMDs) cause pain and dysfunction in the masticatory system, often managed with occlusal splint therapy. However, splint therapy alone may yield inconsistent results. Low-level laser therapy (LLLT) has been proposed as an adjunctive treatment to enhance pain relief and muscle function through photo biomodulation. Evidence comparing the efficacy of splint therapy alone versus its combination with LLLT remains limited. This study aims to evaluate, clinically and electromyographically.
The evidence for occlusal splints is mixed: some systematic reviews report possible short-term benefits for muscle pain but overall the evidence is inconclusive and of variable quality. Low-level laser therapy (LLLT) has been studied for TMD and orofacial pain with several systematic reviews and meta-analyses showing potential analgesic and anti-inflammatory effects, though study heterogeneity exists.
EMG will be used for measurement of muscle activity before and after occlusal splint and low level laser in patients with pain in TMJ.
Read the detailed description
Temporomandibular disorders (TMDs) represent a diverse group of conditions involving the masticatory muscles, temporomandibular joint, and related craniofacial structures. These conditions are frequently associated with pain, functional limitations, and a diminished quality of life.
As the second most prevalent cause of orofacial pain following dental pathologies, TMDs are recognized as multifactorial in origin, influenced by genetic, biological, behavioural, and environmental determinants.
The intricate nature of TMD pathogenesis necessitates a comprehensive diagnostic framework and a broad spectrum of therapeutic approaches, underscoring the importance of research into effective management strategies for improved patient outcomes .
Both traditional and modern treatments for TMD range from conservative, reversible approaches as occlusal splints and physiotherapy to more invasive surgical procedures, which are typically reserved for severe or unresponsive cases. Among conservative methods, occlusal splints and low-level laser therapy (LLLT) have gained prominence for their effectiveness in relieving pain, reducing joint sounds, and improving muscular function and mouth opening in TMD patients.
Nevertheless, the underlying mechanisms by which these interventions influence muscle activity and pain perception particularly when assessed through electromyography require further elucidation.
While occlusal splints primarily function by modifying occlusal forces and jaw alignment, low-level laser therapy, also referred to as photo biomodulation therapy (PBMT), exerts its effects at the cellular level, promoting analgesic, anti-inflammatory, and tissue-repair responses.The application of wireless electromyography offers objective data on muscle function, providing a quantitative assessment of the neuromuscular effects of these interventions.
This objective evaluation enables a deeper understanding of whether these therapies produce comparable improvements in muscle coordination and reductions in abnormal muscle activity associated with TMD. Such comparative investigations are vital for determining the most effective conservative management strategies, given the substantial burden TMD imposes on both individuals and healthcare systems. Considering the widespread prevalence of these disorders, a comprehensive understanding of the physiological responses elicited by various treatment modalities is essential for evidence-based clinical decision-making.
Although both occlusal splints and low-level laser therapy have demonstrated efficacy in managing TMD, their differing mechanisms mechanical modification versus photo biomodulation may yield distinct physiological outcomes in the masticatory system . Accordingly, exploring their comparative effectiveness through quantitative tools such as wireless electromyography provides valuable insight into their respective roles in neuromuscular regulation and pain reduction.
Low-level laser therapy, or photo biomodulation therapy, employs specific wavelengths of light to stimulate cellular metabolism, mitigate inflammation, and relieve pain, thereby offering a non-invasive treatment option for a variety of musculoskeletal disorders, including TMD. This modality has demonstrated beneficial outcomes in wound and bone healing, pain management, and temporomandibular joint therapy, with noticeable effects occurring shortly after application.
Classified as a "soft laser" due to its low energy output, it differs from "hard lasers" utilized in surgical contexts.In TMD management, LLLT has been reported to induce alterations in masseter muscle dynamics and to significantly reduce pain intensity.
Its therapeutic potential is attributed to enhanced microcirculation, accelerated cellular regeneration, and modulation of inflammatory mediators, which collectively promote tissue healing and pain relief .
The analgesic, anti-inflammatory, and regenerative effects of LLLT further support its use in addressing myogenic temporomandibular joint disorders.
Conversely, occlusal splints act primarily by modifying occlusal relationships, thereby reducing parafunctional behaviors and evenly distributing occlusal forces across the dental arches. This mechanism alleviates muscle spasm and decreases joint loading.
The effectiveness of occlusal splints in reducing masticatory muscle hyperactivity and orofacial pain is well established, with evidence indicating decreased bruxism and improved comfort. However, while some studies report superior pain relief and functional improvement with stabilization splints, even placebo splints with minimal occlusal alterations have shown partial efficacy, suggesting that factors beyond occlusal changes or condylar positioning contribute to symptom relief.
This underscores the complex interaction of biomechanical, neurological, and psychological components in TMD therapy, implying that the benefits of occlusal splints extend beyond mechanical adjustments alone. Specifically, hard stabilization splints have been shown to effectively reduce TMD pain, though comparisons among different splint types often yield inconsistent findings regarding superiority.
Additionally, splint design and material such as soft versus hard variants can influence therapeutic results, with hard splints often favored for their durability and capacity to facilitate proper condylar positioning.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Low Level Laser Therapy
- 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.
Low Level Laser TherapyProcedure or surgery
Also called Occlusal splint therapy
to evaluate the treatment of Tempromandibular Joint disorders by low-level laser therapy with occlusal splint treatment or occlusal splint therapy alone in reducing pain intensity and improving masticatory muscle activity, as assessed clinically and electromyographically.
| Study group | Role | What they receive |
|---|---|---|
| Occlusal Splint Therapy + Low-Level Laser Therapy (LLLT) | Active comparator | About 12 Patients will receive the same occlusal splint plus adjunctive LLLT applied to the TMJ and masticatory muscles on the masseter and temporalis muscles. for 3 sessions per week for 4 weeks and follow up for 3 months. Receives: Procedure: Low Level Laser Therapy |
| Occlusal Splint Therapy Only | Active comparator | About 12 Patients will receive a Hard splint maxillary appliance.The splint will provide uniform occlusal contact with the opposing teeth in centric relation and canine-guided. the patients must follow these instructions:
* Wear the splint every night during sleep and, if possible, 2-3 hours during the day.
* Maintain oral hygiene and clean the splint with a soft brush and mild soap daily.
* Avoid chewing hard foods or parafunctional habits during the treatment period.
* Follow-up evaluations at 3 months to assess pain, mouth opening, and muscle activity. Receives: Procedure: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Tempromandibular joint Pain
Treatment of pain resulting from Tempromandibular joint disorders by Occlusal splints in combination with low level laser therapy assessed by Visual Analog Scale (VAS) from 0 to10 where 0 is the worse while the 10 is the best results
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion10 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 Joint DisordersStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Mohamed Ebrahim, Future University in Egypt
- Investigators
- Waleed Fathy Ali Esmael, Professor, Study chair, oral and maxillofacial surgery,Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878247
- Sponsor's protocol ID
- Temporomandibular Disorders
- Status last verified
- Dec 2025
- First submitted
- 10 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Electromyographic Assessment of Occlusal Splint Therapy With and Without Low-Level Laser in Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT07878247
- Acronym / sponsor ID
- Temporomandibular Disorders
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 16 Oct 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) cause pain and dysfunction in the masticatory system, often managed with occlusal splint therapy. However, splint therapy alone may yield inconsistent results. Low-level laser therapy (LLLT) has been proposed as an adjunctive treatment to enhance pain relief and muscle function through photo biomodulation. Evidence comparing the efficacy of splint therapy alone versus its combination with LLLT remains limited. This study aims to evaluate, clinically and electromyographically.
The evidence for occlusal splints is mixed: some systematic reviews report possible short-term benefits for muscle pain but overall the evidence is inconclusive and of variable quality. Low-level laser therapy (LLLT) has been studied for TMD and orofacial pain with several systematic reviews and meta-analyses showing potential analgesic and anti-inflammatory effects, though study heterogeneity exists.
EMG will be used for measurement of muscle activity before and after occlusal splint and low level laser in patients with pain in TMJ.
Detailed description
Temporomandibular disorders (TMDs) represent a diverse group of conditions involving the masticatory muscles, temporomandibular joint, and related craniofacial structures. These conditions are frequently associated with pain, functional limitations, and a diminished quality of life.
As the second most prevalent cause of orofacial pain following dental pathologies, TMDs are recognized as multifactorial in origin, influenced by genetic, biological, behavioural, and environmental determinants.
The intricate nature of TMD pathogenesis necessitates a comprehensive diagnostic framework and a broad spectrum of therapeutic approaches, underscoring the importance of research into effective management strategies for improved patient outcomes .
Both traditional and modern treatments for TMD range from conservative, reversible approaches as occlusal splints and physiotherapy to more invasive surgical procedures, which are typically reserved for severe or unresponsive cases. Among conservative methods, occlusal splints and low-level laser therapy (LLLT) have gained prominence for their effectiveness in relieving pain, reducing joint sounds, and improving muscular function and mouth opening in TMD patients.
Nevertheless, the underlying mechanisms by which these interventions influence muscle activity and pain perception particularly when assessed through electromyography require further elucidation.
While occlusal splints primarily function by modifying occlusal forces and jaw alignment, low-level laser therapy, also referred to as photo biomodulation therapy (PBMT), exerts its effects at the cellular level, promoting analgesic, anti-inflammatory, and tissue-repair responses.The application of wireless electromyography offers objective data on muscle function, providing a quantitative assessment of the neuromuscular effects of these interventions.
This objective evaluation enables a deeper understanding of whether these therapies produce comparable improvements in muscle coordination and reductions in abnormal muscle activity associated with TMD. Such comparative investigations are vital for determining the most effective conservative management strategies, given the substantial burden TMD imposes on both individuals and healthcare systems. Considering the widespread prevalence of these disorders, a comprehensive understanding of the physiological responses elicited by various treatment modalities is essential for evidence-based clinical decision-making.
Although both occlusal splints and low-level laser therapy have demonstrated efficacy in managing TMD, their differing mechanisms mechanical modification versus photo biomodulation may yield distinct physiological outcomes in the masticatory system . Accordingly, exploring their comparative effectiveness through quantitative tools such as wireless electromyography provides valuable insight into their respective roles in neuromuscular regulation and pain reduction.
Low-level laser therapy, or photo biomodulation therapy, employs specific wavelengths of light to stimulate cellular metabolism, mitigate inflammation, and relieve pain, thereby offering a non-invasive treatment option for a variety of musculoskeletal disorders, including TMD. This modality has demonstrated beneficial outcomes in wound and bone healing, pain management, and temporomandibular joint therapy, with noticeable effects occurring shortly after application.
Classified as a "soft laser" due to its low energy output, it differs from "hard lasers" utilized in surgical contexts.In TMD management, LLLT has been reported to induce alterations in masseter muscle dynamics and to significantly reduce pain intensity.
Its therapeutic potential is attributed to enhanced microcirculation, accelerated cellular regeneration, and modulation of inflammatory mediators, which collectively promote tissue healing and pain relief .
The analgesic, anti-inflammatory, and regenerative effects of LLLT further support its use in addressing myogenic temporomandibular joint disorders.
Conversely, occlusal splints act primarily by modifying occlusal relationships, thereby reducing parafunctional behaviors and evenly distributing occlusal forces across the dental arches. This mechanism alleviates muscle spasm and decreases joint loading.
The effectiveness of occlusal splints in reducing masticatory muscle hyperactivity and orofacial pain is well established, with evidence indicating decreased bruxism and improved comfort. However, while some studies report superior pain relief and functional improvement with stabilization splints, even placebo splints with minimal occlusal alterations have shown partial efficacy, suggesting that factors beyond occlusal changes or condylar positioning contribute to symptom relief.
This underscores the complex interaction of biomechanical, neurological, and psychological components in TMD therapy, implying that the benefits of occlusal splints extend beyond mechanical adjustments alone. Specifically, hard stabilization splints have been shown to effectively reduce TMD pain, though comparisons among different splint types often yield inconsistent findings regarding superiority.
Additionally, splint design and material such as soft versus hard variants can influence therapeutic results, with hard splints often favored for their durability and capacity to facilitate proper condylar positioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occlusal Splint Therapy + Low-Level Laser Therapy (LLLT) | Active comparator | Procedure: Low Level Laser TherapyAbout 12 Patients will receive the same occlusal splint plus adjunctive LLLT applied to the TMJ and masticatory muscles on the masseter and temporalis muscles. for 3 sessions per week for 4 weeks and follow up for 3 months. |
| Occlusal Splint Therapy Only | Active comparator | Procedure: Low Level Laser TherapyAbout 12 Patients will receive a Hard splint maxillary appliance.The splint will provide uniform occlusal contact with the opposing teeth in centric relation and canine-guided. the patients must follow these instructions: * Wear the splint every night during sleep and, if possible, 2-3 hours during the day. * Maintain oral hygiene and clean the splint with a soft brush and mild soap daily. * Avoid chewing hard foods or parafunctional habits during the treatment period. * Follow-up evaluations at 3 months to assess pain, mouth opening, and muscle activity. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients who had a Diagnosis of TMD, with chronic pain, muscle spasms, myofascial pain syndrome lasts at least 3 months, and challenges while chewing
- Patients who have Bruxism
Key exclusion criteria (6 listed)
- Patients with a history of trauma, fracture, or surgery involving the temporomandibular joint.
- Presence of systemic or neuromuscular diseases (e.g., rheumatoid arthritis, fibromyalgia, Parkinson's disease).
- Ongoing orthodontic treatment or recent prosthodontic rehabilitation affecting occlusion.
- Use of analgesics, muscle relaxants, or anti-inflammatory drugs within two weeks before the study.
- Pregnant or lactating women.
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 |
|---|---|---|
| Low Level Laser TherapyAlso: Occlusal splint therapyto evaluate the treatment of Tempromandibular Joint disorders by low-level laser therapy with occlusal splint treatment or occlusal splint therapy alone in reducing pain intensity and improving masticatory muscle activity, as assessed clinically and electromyographically. | Procedure or surgery | Occlusal Splint Therapy + Low-Level Laser Therapy (LLLT), Occlusal Splint Therapy Only |
Primary outcome
Treatment of Tempromandibular joint Pain
Time frame: 3 months
Treatment of pain resulting from Tempromandibular joint disorders by Occlusal splints in combination with low level laser therapy assessed by Visual Analog Scale (VAS) from 0 to10 where 0 is the worse while the 10 is the best results
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 16 Oct 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.
Waleed Fathy Ali Esmael, Professor study chair
oral and maxillofacial surgery,Future University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Temporomandibular Joint Disorders, run by Future University in Egypt 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 2 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: looking for participants now, as of the sponsor's last update on 16 Oct 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 Salma Mohamed Ebrahim Ali Monsef, B.D.S. (+201012569500, Salma11monsef@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of Tempromandibular joint Pain (time frame: 3 months). 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 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.