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

Not Applicable

• Conditions: Temporomandibular Joint Disorders
• Interventions: Other: Placebo comparator; Device: low-level laser therapy

• Registration Number: NCT02928809
• Lead Sponsor: University of Nove de Julho

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-09-30
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-10
• Status Verified: 2016-12
• Study Start: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
TMD placebo	Placebo comparator	Patients with diagnosis of temporomandibular disorder and that are submitted to placebo low-level laser treatment
TMD LLL	low-level laser therapy	Patients with diagnosis of temporomandibular disorder and that are submitted to pre-fatigue low-level laser therapy
Without TMD LLL	low-level laser therapy	Patients without diagnosis of temporomandibular disorder and that are submitted to pre-fatigue low-level laser therapy
Without TMD placebo	Placebo comparator	Patients without diagnosis of temporomandibular disorder and that are submitted to placebo low-level laser treatment

Primary Outcome Measures

Name	Time	Method
Change on Bite Force	6 minutes	A digital dynamometer will be used for the determination of bite force. The measurements will be taken in the region of the 1st molars.

Secondary Outcome Measures

Name	Time	Method
Change on range of mandibular movements	6 minutes	The individuals will be instructed to open their mouths as wide as possible and maximum active vertical mandibular movement (distance between maxillary and mandibular central incisors) will be recorded with the aid of digital calipers. The individuals will then be instructed to repeat the motion with pressure applied to the maxillary and mandibular teeth to obtain maximum passive vertical mandibular movement with the aid of the calipers. These measurements will be made before and after LLLT.

Trial Locations

Locations (1)

Universidade Nove de Julho; 🇧🇷 Sao Paulo, SP, Brazil