Photobiomodulation on Pain in Patients With Temporomandibular Dysfunction

NCT06068959 | Unknown

• 1 other identifier: 220824a
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. It is a randomized, controlled, and blind clinical trial, which will consist of n= 36, of both genders, with ages ranging from 18 to 45 years, divided into 2 groups: Group 1 Red and infrared LED cluster, Group 2 placebo. The areas where they will receive photobiomodulation will be the TMJ area, masseter muscles, temporal muscles, scalenes, and trapezius. 6 non-consecutive sessions will be performed over 2 weeks. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to determine TMD and validate participants. To validate the mandibular range of motion (ADM) a pachymeter will be used and for the cervical ADM a goniometer (fleximeter). The pain will be validated using the visual analog scale-VAS. All participants will be evaluated after the first therapeutic intervention, and again at the end, following the same validation procedures used initially.

Conditions

TMJ Pain

Outcome Measures

Primary Outcomes (2)

• Pain Baseline

  Evaluation of Pain using visual analogic scale in centimeters (0-10cm)

  Before an intervention

• Final Pain

  Evaluation of Pain using visual analogic scale in centimeters (0-10cm)

  2 weeks after treatment

Secondary Outcomes (4)

• Cervical spine mobility baseline

  Before an intervention

• Final Cervical spine mobility

  2 weeks after intervention

• Mandibular mobility baseline

  Before an intervention

• Final Mandibular mobility

  2 weeks after intervention

Study Arms (2)

Photobiomodulation

EXPERIMENTAL

Photobiomodulation using a LED cluster

Device: Photobiomodulation using LED

Placebo Photobiomodulation

PLACEBO COMPARATOR

Placebo Photobiomodulation with the equipment turned off

Device: Placebo

Interventions

Photobiomodulation using LED DEVICE

Photobiomodulation Using a Cluster of LEDs in the Red and Infrared Wavelengths in the Cervical Spine Region and Over the Masticatory Muscles

Photobiomodulation

Placebo DEVICE

Photobiomodulation Placebo

Placebo Photobiomodulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• present TMD according Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I
• have all permanent teeth

You may not qualify if:

• be undergoing orthodontic treatment
• be undergoing other treatment for TMD
• present dental caries or gingival disease.
• Initiate or use any type of medication during the phases of the study
• comorbidity

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: February 29, 2024
• Primary Completion: July 10, 2024
• Study Completion: August 10, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-09