NCT07878247|RecruitingDMC
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Sponsor study identifier
interventional
24
1 country
1
Study Start
December 1, 2025
Actual (reported)Primary Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 10, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 10, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2025
Actual (reported)October 10, 2026
Actual (reported)October 16, 2026
Actual (reported)December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 10, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
3 months
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Future University in Egypt (FUE)
Cairo, Egypt
Waleed Fathy Ali Esmael, Professor
oral and maxillofacial surgery,Future University in Egypt
First Submitted
October 10, 2026
First Posted
October 16, 2026
Study Start
December 1, 2025
Actual (reported)Primary Completion
December 1, 2026
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 10, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 16, 2026
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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