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

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

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorder
• Intervention / Treatment: Device: Low- level laser- photobiomodulation therapy

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Department of Maxillofacial Surgery at the University Hospital Complex of Salamanca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum mouth opening	To measure the maximum mouth opening (MMO), a digital gauge (Ubermann®) was used, taking two measurements, and the average was used for statistical analysis.	Baseline and four weeks after the treatment
Depression and anxiety	The Depression Anxiety Stress Scales-21 (DASS-21) questionnaire was used to assess affective states through the 21 questions that make up the tool. Scores are reported as a total score (ranging from 0 to 63) and individual scores for three subscales (ranging from 0 to 21). Additionally, percentiles are calculated based on community samples. Each subscale score is classified into five severity levels: normal, mild, moderate, severe, and extremely severe.	Baseline and four weeks after the treatment
Satisfaction with the treatment	The degree of satisfaction with the treatment received was evaluated in the patients. For this purpose, the Likert scale was used, a validated scale consisting of 5 items that evaluates attitudes, perceptions or levels of satisfaction.	Four weeks after the treatment

Collaborators and Investigators

• Sponsor: University of Coimbra
• Collaborators: University of Salamanca
• Investigators: Principal Investigator: Nanci Lopez-Valverde, PhD, University of Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: TMD; Temporomandibular disorders; low- level laser- photobiomodulation therapy; myofascial TMD
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: USUCLLT2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes