Sleep Hygiene Measures for Sleep Bruxism in Children

Not Applicable

• Conditions: Sleep Bruxism, Childhood
• Interventions: Behavioral: Bruxers with sleep hygiene instructions

• Registration Number: NCT04501237
• Lead Sponsor: Federal University of Pelotas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Last Update Submitted: 2020-08-03
• Study First Posted: 2020-08-06
• Last Update Posted: 2020-08-06
• Study Start: 2020-09-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bruxers with sleep hygiene instructions	Bruxers with sleep hygiene instructions	-

Primary Outcome Measures

Name	Time	Method
Questionnaire	Responded 1 month after intervention in both groups	Strengths and Difficulties Questionnaire

Secondary Outcome Measures

Name	Time	Method
Clinical evaluation of child teeth	Analyzed 1 month after intervention in both groups	Basic Erosive Wear Examination Index

Trial Locations

Locations (1)

School of dentistry; 🇧🇷 Pelotas, RS, Brazil