Photobiomodulation on Pain in Patients With Temporomandibular Dysfunction

TMJ Pain Clinical Trial

Official title:

Effect of Photobiomodulation With LED Cluster on Pain and Mandibular and Cervical Mobility in Patients With Temporomandibular Dysfunction: Clinical, Randomized, Controlled and Blind Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06068959
• Other study ID #: 220824a
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: August 10, 2024

Study information

• Verified date: September 2023
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The term temporomandibular disorders (TMD), according to the American American Dental Association (ADA), refers to a group of disorders characterized by pain in the temporomandibular joint (TMD) in the periauricular area or in the masticatory muscles, in addition to TMD sounds during jaw function and deviation or restriction of jaw movements. Its multifactorial etiology is related to a heterogeneous group of functional, structural, and psychological factors, making it difficult to identify the association between a single etiological factor and the signs and symptoms of TMD. As a treatment option, it hasphotobiomodulation, using different light sources, alone or in combination. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: August 10, 2024
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• TMJ Pain

Intervention

Device:
• Photobiomodulation using LED
Photobiomodulation Using a Cluster of LEDs in the Red and Infrared Wavelengths in the Cervical Spine Region and Over the Masticatory Muscles
• Placebo
Photobiomodulation Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Baseline	Evaluation of Pain using visual analogic scale in centimeters (0-10cm)	Before an intervention
Primary	Final Pain	Evaluation of Pain using visual analogic scale in centimeters (0-10cm)	2 weeks after treatment
Secondary	Cervical spine mobility baseline	Evaluation of cervical spine mobility using goniometer in degrees	Before an intervention
Secondary	Final Cervical spine mobility	Evaluation of cervical spine mobility using goniometer in degrees	2 weeks after intervention
Secondary	Mandibular mobility baseline	Evaluation of mandibular mobility using caliper in millimeters	Before an intervention
Secondary	Final Mandibular mobility	Evaluation of mandibular mobility using caliper in millimeters	2 weeks after intervention