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Completed

NCT Number: NCT06915064

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

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

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Key information

Conditions

Temporomandibular Joint Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Maxillofacial Surgery at the University Hospital Complex of Salamanca

Salamanca, 37007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Severity and frequency of the symptoms

    Time frame: Baseline and four weeks after the treatment

    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.

  2. Pain Intensity

    Time frame: Baseline and four weeks after the treatment

    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.

  3. Pressure pain threshold

    Time frame: Baseline and four weeks after the treatment

    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).

Secondary outcomes

  1. Maximum mouth opening

    Time frame: Baseline and four weeks after the treatment

    To measure the maximum mouth opening (MMO), a digital gauge (Ubermann®) was used, taking two measurements, and the average was used for statistical analysis.

  2. Depression and anxiety

    Time frame: Baseline and four weeks after the treatment

    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.

  3. Satisfaction with the treatment

    Time frame: Four weeks after 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.

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Collaborators

  • University of Salamanca

Registry information

Official study title

Effect of Photobiomodulation in Patients With Temporomandibular Dysfunction Refractory to Botulinum Toxin Treatment: A Non-controlled Multicentric Pilot Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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