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

Completed

• Conditions: Temporomandibular Joint Disorder

• Registration Number: NCT06915064
• Lead Sponsor: University of Coimbra

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Study First Submitted: 2025-03-24
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold	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).
Severity and frequency of the symptoms	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.
Pain Intensity	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.

Secondary Outcome Measures

Name	Time	Method
Maximum mouth opening	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.
Depression and anxiety	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.
Satisfaction with the treatment	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.

Trial Locations

Locations (1)

Department of Maxillofacial Surgery at the University Hospital Complex of Salamanca; 🇪🇸 Salamanca, Spain