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

NCT02757261 | Unknown Early Phase 1 DMC

• 1 other identifier: 1.333.636
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Sleep Bruxism

Keywords

Bruxism; Child; Occlusal splint; Bite force; Acunpuncture; Laser; Muscle actvity; Salivary Cortisol

Outcome Measures

Primary Outcomes (3)

• Change in ELECTROMYOGRAPHIC EVALUATION OF MASTICATORY AND TRAPEZIUS MUSCLES

  six-channel BTS TMJOINT electromyograph (BTS Engineering)

  Before and after treatment and follow up 1 month and 6 months

• Change in Bite force

  Bite force will be measured using a digital gnathodynamometer (DMD, Kratos Equipamentos Industriais Ltda, Cotia, São Paulo, Brazil) adapted for oral conditions

  Before and after treatment and follow up 1 month and 6 months

• Change in Salivary cortisol

  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).

  Before and after treatment and follow up 1 month and 6 months

Study Arms (4)

Application of Low-level laser therapy.

EXPERIMENTAL

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

Treatment with Occlusal splint.

EXPERIMENTAL

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

Placebo laser

ACTIVE COMPARATOR

Placebo laser will be performed using the same equipment.

Device: Placebo laser

Children without bruxism

NO INTERVENTION

Control group

Interventions

Laser DEVICE

Low-level laser therapy administrated to acupoints

Application of Low-level laser therapy.

Occlusal splint DEVICE

Occlusal splint with expander

Treatment with Occlusal splint.

Placebo laser DEVICE

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

Placebo laser

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Nove de Julho: lead

Related Publications (1)

• Salgueiro MDCC, Bortoletto CC, Horliana ACR, Mota ACC, Motta LJ, Motta PB, MesquitaFerrari RA, Fernandes KPS, Bussadori SK. Evaluation of muscle activity, bite force and salivary cortisol in children with bruxism before and after low level laser applied to acupoints: study protocol for a randomised controlled trial. BMC Complement Altern Med. 2017 Aug 8;17(1):391. doi: 10.1186/s12906-017-1905-y.

  PMID: 28789647 DERIVED

MeSH Terms

Conditions

Sleep Bruxism; Bruxism

Interventions

Lasers; Occlusal Splints

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Habits; Behavior

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Monica Canuto Salgueiro

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: May 2, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 2, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share