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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04501237
Study type Interventional
Source Federal University of Pelotas
Contact Marilia L Goettems, PhD
Phone 555332256741
Email mariliagoettems@gmail.com
Status Recruiting
Phase N/A
Start date September 1, 2020
Completion date May 1, 2021

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05301452 - Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism Phase 2
Completed NCT05323942 - The Effect of Sleep Hygiene and Exercise Therapy in Children With Sleep Bruxism N/A
Not yet recruiting NCT05310162 - Effect of the Intervention "Food, Fun and Family" on Sleep Bruxism in Children N/A