Clinical trial NCT06915064: Effect of Photobiomodulation in Patients With Temporomandibular Dysfunction Refractory to Botulinum Toxin Treatment.
Official title: Effect of Photobiomodulation in Patients With Temporomandibular Dysfunction Refractory to Botulinum Toxin Treatment: A Non-controlled Multicentric Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Joint Disorder
Keywords: Temporomandibular disorders
low- level laser- photobiomodulation therapy
TMD
myofascial TMD
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: University of Salamanca
First posted: 2025-04-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ten female patients were included who attended the Department of Maxillofacial Surgery at the University Hospital Complex of Salamanca.

Brief 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


Eligibility criteria: Inclusion Criteria:

* Female patients diagnosed with TMDs. Presence of unilateral or bilateral painful symptoms. Associated conditions: Bruxism, hypertrophy of the masticatory muscles, headaches
* Previous treatment with BTX:

Minimum of 3 doses (100 IU) Applied in masticatory muscles and intracapsular area No favorable results obtained

Exclusion Criteria:

* Patients without prior treatment of this type.
* Patients receiving treatment in the Pain Unit.
* Patients undergoing invasive treatments: Open surgery in the cervicofacial region or TMJ arthrocentesis.

Primary outcomes:
measure: Severity and frequency of the symptoms
timeFrame: Baseline and four weeks after the treatment
measure: Pain Intensity
timeFrame: Baseline and four weeks after the treatment
measure: Pressure pain threshold
timeFrame: Baseline and four weeks after the treatment
Secondary outcomes:
measure: Maximum mouth opening
timeFrame: Baseline and four weeks after the treatment
measure: Depression and anxiety
timeFrame: Baseline and four weeks after the treatment
measure: Satisfaction with the treatment
timeFrame: Four weeks after the treatment
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Department of Maxillofacial Surgery at the University Hospital Complex of Salamanca
Study officials:
affiliation: University of Salamanca
name: Nanci Lopez-Valverde, PhD
role: PRINCIPAL_INVESTIGATOR
References: