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Evaluation of Muscle Activity, Bite Force and Salivary Cortisol in Children With Bruxism

NCT02757261 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2016-05-02

No results posted yet for this study

Summary

Bruxism is a repetitive activity of the masticatory muscles characterized by grinding and/or clenching one's teeth or parafunctional movements of the mandible. The aim of the proposed controlled clinical trial is to evaluate muscle activity, bite force and salivary cortisol in children aged six to eight years with bruxism. The children will be randomly allocated to four groups, each with 19 participants: Group 1 will receive low-level laser therapy at acupuncture points; Group 2 will use an occlusal splint; Group 3 will receive placebo laser therapy; and Group 4 will be the control group without bruxism. Low-level laser (786.94 nm, 0.04 cm2, 70 mW and 20 s per points) will be applied directly on the skin at six acupuncture points on each side. The BTS TMJOINT electromyograph will be used to determine muscle activity and a digital gnathodynamometer will be used to measure bite force. Two saliva collections will be performed in the participant's home at 9 am and prior to going to sleep, with at least one hour of fasting and followed by oral hygiene with water. Evaluations will be performed before as well as one and six months after treatment. The findings will be computed and submitted to statistical analysis. Descriptive statistics will be used first for the determination of point estimates, precision and validation using analysis of variance (ANOVA) for the evaluation of residuals and parametric tests will be used for the determination of pre-treatment conditions. Interval estimates will be used for the variables of interest to determine the prevision of the estimates and perform comparisons. When necessary, transformation methods or non-parametric tests will be used in the data analysis. The chi-square test, Student's t-test and ANOVA will be employed, with the level of significance set at 5% (p \< 0.05).

Conditions

  • Sleep Bruxism

Interventions

DEVICE

Laser

Low-level laser therapy administrated to acupoints

DEVICE

Occlusal splint

Occlusal splint with expander

DEVICE

Placebo laser

Placebo laser (Low-level laser therapy administrated to acupoints)

Sponsors & Collaborators

  • University of Nove de Julho

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-10-31
Completion
2017-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02757261 on ClinicalTrials.gov