Sleep Hygiene Measures for Sleep Bruxism in Children

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep Bruxism, Childhood

Intervention / Treatment
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* Behavioral: Bruxers with sleep hygiene instructions


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |