Effect of Photobiomodulation in Patients With Temporomandibular Dysfunction Refractory to Botulinum Toxin Treatment.
NCT ID: NCT06915064
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2024-03-01
2025-03-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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LLLT-PBMT
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Previous treatment with BTX:
Minimum of 3 doses (100 IU) Applied in masticatory muscles and intracapsular area No favorable results obtained
Exclusion Criteria
* Patients receiving treatment in the Pain Unit.
* Patients undergoing invasive treatments: Open surgery in the cervicofacial region or TMJ arthrocentesis.
18 Years
FEMALE
No
Sponsors
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University of Salamanca
OTHER
University of Coimbra
OTHER
Responsible Party
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Bruno Macedo de Sousa
Professor
Principal Investigators
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Nanci Lopez-Valverde, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Salamanca
Locations
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Department of Maxillofacial Surgery at the University Hospital Complex of Salamanca
Salamanca, Salamanca, Spain
Countries
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Other Identifiers
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USUCLLT2025
Identifier Type: -
Identifier Source: org_study_id
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