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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06915064
Enrollment
10
Registered
2025-04-08
Start date
2024-03-01
Completion date
2025-03-01
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disorder

Keywords

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

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

Interventions

DEVICELow- 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

Sponsors

University of Salamanca
CollaboratorOTHER
University of Coimbra
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Severity and frequency of the symptomsBaseline and four weeks after the treatmentTo 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.
Pain IntensityBaseline and four weeks after the treatmentFor 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.
Pressure pain thresholdBaseline and four weeks after the treatmentPressure 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).

Secondary

MeasureTime frameDescription
Depression and anxietyBaseline and four weeks after the treatmentThe 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.
Maximum mouth openingBaseline and four weeks after the treatmentTo measure the maximum mouth opening (MMO), a digital gauge (Ubermann®) was used, taking two measurements, and the average was used for statistical analysis.
Satisfaction with the treatmentFour weeks after the treatmentThe 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026