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

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ClinicalTrials.gov Identifier: NCT02757261
Recruitment Status : Unknown
Verified April 2016 by Monica Canuto Salgueiro, University of Nove de Julho.
Recruitment status was:  Not yet recruiting
First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Monica Canuto Salgueiro, University of Nove de Julho

Brief 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).

Condition or disease Intervention/treatment Phase
Sleep Bruxism Device: Laser Device: Occlusal splint Device: Placebo laser Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Evaluation of Muscle Activity, Bite Force and Salivary Cortisol in Children With Bruxism Before and After Laser Use of Low Power in Acupoints- Controlled Clinical Trial
Study Start Date : June 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: Application of Low-level laser therapy.
The intervention will be twelve sessions (two per week). Laser parameters: wavelength - 786.94 nm; conventional tip; energy density - 25 J/cm²; intensity - 1.675 mW/cm²; output power - 70 mW (0.070 W); and exposure time - 20 seconds per point. The point application method will be used with direct contact with the skin (spot beam of 0.04 cm²), following the protocol suggested by Carvalho et al.50 and Venezian et al.44 A potentiometer will be used to determine the mean power of the laser equipment to ensure the safety of the operator.
Device: Laser
Low-level laser therapy administrated to acupoints

Experimental: Treatment with Occlusal splint.
The intervention will be a maxillary occlusal splint will be used on the maxilla with palatal and occlusal coverage. Following the protocol established by Hachmann et al., the children will only use the splint at night for two months, with weekly adjustments of a quarter turn.46
Device: Occlusal splint
Occlusal splint with expander

Active Comparator: Placebo laser
Placebo laser will be performed using the same equipment.
Device: Placebo laser
Placebo laser (Low-level laser therapy administrated to acupoints)

No Intervention: Children without bruxism
Control group



Primary Outcome Measures :
  1. Change in ELECTROMYOGRAPHIC EVALUATION OF MASTICATORY AND TRAPEZIUS MUSCLES [ Time Frame: Before and after treatment and follow up 1 month and 6 months ]
    six-channel BTS TMJOINT electromyograph (BTS Engineering)

  2. Change in Bite force [ Time Frame: Before and after treatment and follow up 1 month and 6 months ]
    Bite force will be measured using a digital gnathodynamometer (DMD, Kratos Equipamentos Industriais Ltda, Cotia, São Paulo, Brazil) adapted for oral conditions

  3. Change in Salivary cortisol [ Time Frame: Before and after treatment and follow up 1 month and 6 months ]
    Saliva will be collected on cotton swabs, which will be left in the mouth for two minutes. The cotton will then be placed into a centrifuge tube and the sample will be stored at -20° C until analysis.25 Salivary cortisol will be measured prior to therapy and on Day 50 to measure the degree of stress. Two collections will be performed in the home of the participant at 9 am and prior to going to sleep with at least one hour of fasting prior to the collection and will be followed with oral hygiene with water. The collection will be performed on a Sunday following the manufacturer's recommendations and will be delivered on the following Monday for analysis at University Nove de Julho (Brazil).



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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female children
  • Aged six to eight years
  • No physical or psychiatric limitations
  • Need to have the first molars in Angle Class I
  • Free of dental caries
  • A clinical examination of tooth wear and the reports of parents/caregivers regarding tooth clenching/grinding will be used for the diagnosis of bruxism, following the criteria established by the American Academy of Sleep Medicine1 and the use of a questionnaire adapted by Serra Negra (2014).

Exclusion Criteria:

  • Use of muscle relaxants
  • Temporomandibular disorder
  • Currently undergoing another treatment

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Monica Canuto Salgueiro, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02757261     History of Changes
Other Study ID Numbers: 1.333.636
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Monica Canuto Salgueiro, University of Nove de Julho:
Bruxism
Child
Occlusal splint
Bite force
Acunpuncture
Laser
Muscle actvity
Salivary Cortisol

Additional relevant MeSH terms:
Bruxism
Sleep Bruxism
Tooth Diseases
Stomatognathic Diseases
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Salicylic Acid
Anti-Inflammatory Agents
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents