Sleep Hygiene Measures for Sleep Bruxism in Children

Sleep Bruxism, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04501237
• Other study ID #: PPGO 032
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: August 2020
• Source: Federal University of Pelotas
• Contact: Marilia L Goettems, PhD
• Phone: 555332256741
• Email: mariliagoettems[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bruxism
• Sleep Bruxism
• Sleep Bruxism, Childhood

Intervention

Behavioral:
• Bruxers with sleep hygiene instructions
the test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio.

Locations

Country	Name	City	State
Brazil	School of dentistry	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire	Strengths and Difficulties Questionnaire	Responded 1 month after intervention in both groups
Secondary	Clinical evaluation of child teeth	Basic Erosive Wear Examination Index	Analyzed 1 month after intervention in both groups