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RecruitingNCT07878247Updated Oct 16, 2026

Clinical and Electromyographic Assessment of Occlusal Splint Therapy

An interventional study of Low Level Laser Therapy in Temporomandibular Joint Disorders, sponsored by Future University in Egypt. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Dec 2025, registered Oct 2026).
  • Started Dec 2025; still recruiting 10 months later.
Updated Oct 16, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Temporomandibular Joint Disorders
03

In context

Temporomandibular Joint Disorders

621 studies on the registry are indexed under Temporomandibular Joint Disorders; 161 are open to participants now.

This study's planned enrollment of 24 is below the median of 46 across 439 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Future University in Egypt is the lead sponsor of 103 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    Occlusal Splint Therapy + Low-Level Laser Therapy (LLLT)

    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.

    Procedure: Low Level Laser Therapy

  • Active comparator
    Occlusal Splint Therapy Only

    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.

    Procedure: Low Level Laser Therapy

Interventions

  • ProcedureLow Level Laser 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.

    Also known as: Occlusal splint therapy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Future University in Egypt (FUE)
    Cairo, Egypt
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07878247
Responsible party
Salma Mohamed Ebrahim (Resident of Oral and Maxillofacial Surgery, Future University in Egypt) — Principal investigator
First posted
Oct 16, 2026
Start date
Dec 1, 2025
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 10, 2026 (estimated)
Last update
Oct 16, 2026

Study contacts

Salma Mohamed Ebrahim Ali Monsef, B.D.S.
Contact
Salma11monsef@gmail.com
+201012569500
Aya Magdy Abdel-Rady, M.D
Contact
Aya.magdy@fue.edu.eg
+201000252400
Waleed Fathy Ali Esmael, Professor
study chair · oral and maxillofacial surgery,Future University in Egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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