Administration of Low-level Laser on Muscles of Mastication Following the Induction of Initial Fatigue

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Orofacial pain encompasses painful conditions, such as temporomandibular disorder. Multidisciplinary health teams seek to control such musculoskeletal disorders to improve the quality and functional capacity of the muscles of mastication. The aim of the proposed study is to evaluate the effect of low-level laser therapy as a form of treatment for the prevention of initial fatigue of the muscles of mastication (masseter and anterior temporal muscles) as well as the recovery of these muscles after induced exhaustion (caused by isometric contraction) in young adults. The participants will be 78 (n obtained from calculation of the sample size with p \< 0.05) healthy male and female volunteers between 18 and 34 years of age. The volunteers will be randomly allocated to a laser group (n = 26), sham group (n = 26) and control group (n = 26). All participants will be submitted to a clinical evaluation to record mandibular movements, bite force, muscle sensitivity to palpation and initial muscle fatigue. Initial fatigue will be induced by isometric contraction of the jaws. Maximum voluntary contraction will be performed to record the time until initial exhaustion of the masseter muscle (determined by electromyography). The groups will then be submitted to the interventions: 1) active laser therapy (wavelength: 780 nm; fluence: 134 J/cm2; power: 50 mW; irradiance: 1.675 W/cm2; exposure time: 80 seconds per point) on three points of the masseter and one point on the anterior temporal muscles on each side, 2) sham laser (placebo effect) or 3) no intervention (control). Maximum voluntary contraction will be performed again after the interventions to record the time until initial exhaustion of the masseter muscle (determined by electromyography). Differences in individual time until exhaustion between the pre-intervention and post-intervention evaluations will be measured to determine the effect of low-level laser therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Low-level Laser Prior to the Induction of Fatigue

NCT02928809

Temporomandibular Joint Disorders

UNKNOWN NA

Low-level Laser Therapy on Temporomandibular Disorder

NCT01846000

Temporomandibular Disorder

UNKNOWN NA

Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder

NCT03257748

Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder

UNKNOWN PHASE2

Photobiomodulation in Temporomandibular Disorder

NCT03096301

Pain Temporomandibular Disorder

UNKNOWN NA

Efficacy of Different Low Level Laser Therapy Sessions

NCT06327204

Myofascial Pain Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Muscle Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Tiredness will be induced by isometric contraction occlusion time. Patients will be evaluated in two stages. The first moment will be maximum occlusion in all patients in order to be able to measure the individual time for fatigue of the masseter muscle (evaluation by electromyography). The second will have the application of the laser in a group (at the wavelength of 780nm, 134 J / cm2, power of 50 mW irradiance of 1.675 W / cm2, for 80 seconds per point in 3 points in the masseter muscle and one in the temporal muscle on each side); simulation of the application (placebo-psychic factor), control (without application); after this first moment, we will have maximum occlusion in all the patients in order to be able to measure the individual time for fatigue (evaluation by electromyography).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

In the sham group, the laser will be switched off and a recording of the emission sounds will be used to give the volunteer the auditory sensation of laser therapy.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active laser

Three points on the masseter muscle (upper, middle and lower portions) and one point on the anterior temporal on each side of the face will be irradiated with a wavelength of 780 nm, radiant exposure of 134 J/cm2, power of 50 mW and irradiance of 1.675 W/cm2 for 80 seconds per point, resulting in an energy of 4 J per point and total energy of 32 J per volunteer.20,21 Point application will be performed with a conventional tip in contact with the skin (beam spot: 0.04 cm2).

Group Type ACTIVE_COMPARATOR

Active laser

Intervention Type RADIATION

Three points on the masseter muscle (upper, middle and lower portions) and one point on the anterior temporal on each side of the face will be irradiated with a wavelength of 780 nm, radiant exposure of 134 J/cm2, power of 50 mW and irradiance of 1.675 W/cm2 for 80 seconds per point, resulting in an energy of 4 J per point and total energy of 32 J per volunteer.20,21 Point application will be performed with a conventional tip in contact with the skin (beam spot: 0.04 cm2).

Sham laser

The same procedures will be performed in the sham group, but the device will be switched off and a recording of the emission sounds will be used to give the volunteer the auditory sensation of laser therapy.

Group Type SHAM_COMPARATOR

Sham laser

Intervention Type RADIATION

The same procedures will be performed in the sham group, but the device will be switched off and a recording of the emission sounds will be used to give the volunteer the auditory sensation of laser therapy.

Control group

In this group, no treatment will be done, we will only induce fatigue, for evaluation.

Group Type OTHER

Control group

Intervention Type DIAGNOSTIC_TEST

In this group, we will only induce fatigue.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Active laser

Three points on the masseter muscle (upper, middle and lower portions) and one point on the anterior temporal on each side of the face will be irradiated with a wavelength of 780 nm, radiant exposure of 134 J/cm2, power of 50 mW and irradiance of 1.675 W/cm2 for 80 seconds per point, resulting in an energy of 4 J per point and total energy of 32 J per volunteer.20,21 Point application will be performed with a conventional tip in contact with the skin (beam spot: 0.04 cm2).

Intervention Type RADIATION

Sham laser

The same procedures will be performed in the sham group, but the device will be switched off and a recording of the emission sounds will be used to give the volunteer the auditory sensation of laser therapy.

Intervention Type RADIATION

Control group

In this group, we will only induce fatigue.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* will be included in this study young people in the age range between 18-34 years, without diagnosis of temporomandibular disorder (TMD) and with the signed free informed consent term.

Exclusion Criteria

* will be excluded from the study individuals who are in orthodontic or orthopedic treatment of the jaw, psychological and / or physiotherapy. Also excluded are those who are taking anti-inflammatory drugs and anti-inflammatory drugs and occlusal plaques.

Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes