NCT06915064

Effect of Photobiomodulation in Patients With Temporomandibular Dysfunction Refractory to Botulinum Toxin Treatment.

Effect of Photobiomodulation in Patients With Temporomandibular Dysfunction Refractory to Botulinum Toxin Treatment: A Non-controlled Multicentric Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: University of Coimbra · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this preliminary research was to identify the effect of low-level laser photobiomodulation therapy (LLLT-PBMT) in patients with myofascial temporomandibular disorders (TMDs), refractory to botulinum toxin (BTX) treatment. Specifically, the hypothesis of LLLT-PBMT as a safe, low-cost, painless, and minimally invasive alternative therapy was proposed to improve complete muscle recovery and significantly reduce muscle paralysis in patients with masticatory muscle disorders previously treated with BTX. Additionally, different treatment alternatives were investigated, and a protocol was suggested for the application of LLLT-PBMT in myofascial TMDs and the pain associated with masticatory muscles, also analyzing its complications and negative effects

Conditions

• Temporomandibular Joint Disorder

Interventions

Type	Name	Description
DEVICE	Low- level laser- photobiomodulation therapy	Three patients (30%) received treatment on the left side and seven (70%) on the right side. The treatment was carried out using the EPIC X laser (BIOLASE®), which uses a solid-state diode as a semiconductor source of invisible infrared radiation. The therapy was applied to the masticatory muscles (temporal, masseter, internal pterygoid), to trigger points discovered on palpation and to the intra-articular area of the TMJ (posterior portion through the external ear, superior portion and anterior portion). All patients included in the study underwent four sessions of PBMT-LLL for four consecutive weeks. T

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2025-04-08
• Last updated: 2025-04-08

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study