Sleep Hygiene Measures for Sleep Bruxism in Children

Efficacy of Sleep Hygiene Measures in the Occurrence of Sleep Bruxism in Children

The aim of the study is to evaluate the efficacy of sleep hygiene measures for the possible improvement of sleep bruxism in children through a randomized controlled clinical study of children under 8 years of age with probable sleep bruxism. In randomization both groups will receive information about bruxism, and the test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio. The occurrence of sleep bruxism will be assessed through a diary to be completed by the child's responsible party. A randomized, stratified sample of approximately 16 children will be included in the study. One group will be composed of 8 children with probable sleep bruxism who will receive the sleep hygiene intervention, and another group of children who will only receive instructions on sleep bruxism, with causes and consequences. Participants will be followed-up for 30 days. Parents will respond to a questionnaire about socioeconomic, demographic (child's age and gender), as well as parafunctional habits such as nail biting, biting objects, pacifier sucking, finger / thumb sucking and bottle feeding, child's sleep characteristics, screen habits, parental smoking, problems breathing, parental profession and also on psychological issues. Sleep habits will also be answered in this questionnaire, and parents will also answer the Strengths and Difficulties Questionnaire. The children over 6 years old will respond a Child Stress Scale and the Child of stressing sources in child; children less than 6 years will have the questionnaire responded by parents. The children will undergo a clinical examination to assess dental wear, according to the BEWE (Basic Erosive Wear Examination Index). The study evaluations consist of baseline, 1, 7, 15 and 30 days.

Study Overview

• Status: Unknown
• Conditions: Sleep Bruxism, Childhood
• Intervention / Treatment: Behavioral: Bruxers with sleep hygiene instructions

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MArilia L Goettems, PhD; Phone Number: 555332256741; Email: mariliagoettems@gmail.com

Study Locations

• Brazil
  • RS
    • Pelotas, RS, Brazil, 96015560
      • Recruiting
      • School of Dentistry
      • Contact: MArilia L Goettems, PhD; Phone Number: 555332256741; Email: mariliagoettems@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• children with probable sleep bruxism

Exclusion Criteria:

• systemic diseases;
• Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Bruxers without sleep hygiene instructions
Experimental: Bruxers with sleep hygiene instructions	Behavioral: Bruxers with sleep hygiene instructions; the test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire	Strengths and Difficulties Questionnaire	Responded 1 month after intervention in both groups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical evaluation of child teeth	Basic Erosive Wear Examination Index	Analyzed 1 month after intervention in both groups

Collaborators and Investigators

• Sponsor: Federal University of Pelotas

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Stomatognathic Diseases; Parasomnias; Tooth Diseases; Bruxism; Sleep Bruxism
• Other Study ID Numbers: PPGO 032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No