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Sleep Hygiene Measures for Sleep Bruxism in Children

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04501237
Enrollment
20
Registered
2020-08-06
Start date
2020-09-01
Completion date
2021-05-01
Last updated
2020-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Bruxism, Childhood

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.

Interventions

BEHAVIORALBruxers with sleep hygiene instructions

the test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio.

Sponsors

Federal University of Pelotas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
QuestionnaireResponded 1 month after intervention in both groupsStrengths and Difficulties Questionnaire

Secondary

MeasureTime frameDescription
Clinical evaluation of child teethAnalyzed 1 month after intervention in both groupsBasic Erosive Wear Examination Index

Countries

Brazil

Contacts

Primary ContactMarilia L Goettems, PhD
mariliagoettems@gmail.com555332256741

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026