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Clinical Trials/NCT04501237
NCT04501237
Unknown
Not Applicable

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

Federal University of Pelotas1 site in 1 country20 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Bruxism, Childhood
Sponsor
Federal University of Pelotas
Enrollment
20
Locations
1
Primary Endpoint
Questionnaire
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
May 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Pelotas
Responsible Party
Principal Investigator
Principal Investigator

Maximiliano Sergio Cenci

Professor

Federal University of Pelotas

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Questionnaire

Time Frame: Responded 1 month after intervention in both groups

Strengths and Difficulties Questionnaire

Secondary Outcomes

  • Clinical evaluation of child teeth(Analyzed 1 month after intervention in both groups)

Study Sites (1)

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