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

NCT06915064 | Completed DMC FDA Device

• 1 other identifier: USUCLLT2025
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Temporomandibular Joint Disorder

Keywords

Temporomandibular disorders; low- level laser- photobiomodulation therapy; TMD; myofascial TMD

Outcome Measures

Primary Outcomes (3)

• Severity and frequency of the symptoms

  To evaluate both the severity and the frequency of the symptoms associated with TMJ disorders, the anamnestic index of Fonseca was used, considered a valid tool for diagnostic confirmation.

  Baseline and four weeks after the treatment

• Pain Intensity

  For the evaluation of pain, the visual analog scale (VAS) was used, which provides a subjective evaluation of pain, with a scale of values from 0 to 10 representing the intensity of pain in an ascending manner.

  Baseline and four weeks after the treatment

• Pressure pain threshold

  Pressure pain (PP) was measured using a pressure algometer (Wagner FPI 10®) that shows its strength during manual therapy on pressure points (tip of the algometer perpendicular to the muscle, maintaining the pressure which is progressively increased up to 1 kg/sec).

  Baseline and four weeks after the treatment

Secondary Outcomes (3)

• Maximum mouth opening

  Baseline and four weeks after the treatment

• Depression and anxiety

  Baseline and four weeks after the treatment

• Satisfaction with the treatment

  Four weeks after the treatment

Study Arms (1)

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.

Device: Low- level laser- photobiomodulation therapy

Interventions

Low- level laser- photobiomodulation therapy DEVICE

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

LLLT-PBMT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Coimbra: lead
• University of Salamanca: collaborator

Study Sites (1)

Department of Maxillofacial Surgery at the University Hospital Complex of Salamanca

Salamanca, Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Nanci Lopez-Valverde, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 8, 2025
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)