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

U

University of Nove de Julho

Status

Unknown

Conditions

Temporomandibular Joint Disorders

Treatments

Other: Placebo comparator
Device: low-level laser therapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The objective of this study is to perform an evaluation of the effect of LLLT on the prevention of fatigue in the masseter and anterior temporal muscles in young individuals with and without TMD.

Full description

Male and female individuals aged 18 to 23 years will be evaluated. The Research Diagnostic Criteria for Temporomandibular Disorders will be applied for the determination of the presence or absence of temporomandibular disorder. Each group (with and without temporomandibular disorder) will then be randomly allocated into a control group and experimental group submitted to pre-fatigue low-level laser therapy. Before and after the induction of fatigue, all volunteers will be evaluated with regard to the range of mandibular movement, bite force, sensitivity to palpation of the muscles evaluated and muscle fatigue. Low-level laser therapy will be administered to the masseter and anterior temporal muscles prior to the induction of fatigue, which will be induced with the use of chewing gum. The data will be submitted to descriptive statistical analysis. The chi-square test and Fisher's exact test will be used to establish the associations of the categorical variables. Pearson correlation coefficients will be calculated for the analysis of the correlation of the continuous variables.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 23 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male and female individuals aged 18 to 23 years with a signed statement of informed consent will be included in the study.

Exclusion criteria

  • Individuals in orthodontic or orthopedic treatment for the jaws, psychological treatment or physical therapy and those who make use of muscle relaxants, anti-inflammatory agents or bite plates will be excluded from the study.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

90 participants in 6 patient groups, including a placebo group

TMD control
No Intervention group
Description:
Patients with diagnosis of temporomandibular disorder and that are not submitted to pre-fatigue low-level laser therapy
TMD LLL
Experimental group
Description:
Patients with diagnosis of temporomandibular disorder and that are submitted to pre-fatigue low-level laser therapy
Treatment:
Device: low-level laser therapy
Without TMD control
No Intervention group
Description:
Patients without diagnosis of temporomandibular disorder and that are not submitted to pre-fatigue low-level laser therapy
Without TMD LLL
Experimental group
Description:
Patients without diagnosis of temporomandibular disorder and that are submitted to pre-fatigue low-level laser therapy
Treatment:
Device: low-level laser therapy
TMD placebo
Placebo Comparator group
Description:
Patients with diagnosis of temporomandibular disorder and that are submitted to placebo low-level laser treatment
Treatment:
Other: Placebo comparator
Without TMD placebo
Placebo Comparator group
Description:
Patients without diagnosis of temporomandibular disorder and that are submitted to placebo low-level laser treatment
Treatment:
Other: Placebo comparator

Trial contacts and locations

1

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Central trial contact

Camila HL Godoy, MS; Sandra K Bussadori, PHD

Data sourced from clinicaltrials.gov

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