Sleep Hygiene Measures for Sleep Bruxism in Children

NCT04501237 | Unknown

• 1 other identifier: PPGO 032
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Bruxism, Childhood

Outcome Measures

Primary Outcomes (1)

• Questionnaire

  Strengths and Difficulties Questionnaire

  Responded 1 month after intervention in both groups

Secondary Outcomes (1)

• Clinical evaluation of child teeth

  Analyzed 1 month after intervention in both groups

Study Arms (2)

Bruxers without sleep hygiene instructions

NO INTERVENTION

Bruxers with sleep hygiene instructions

EXPERIMENTAL

Behavioral: Bruxers with sleep hygiene instructions

Interventions

Bruxers with sleep hygiene instructions BEHAVIORAL

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

Bruxers with sleep hygiene instructions

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children with probable sleep bruxism

You may not qualify if:

• systemic diseases;
• Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child.

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

School of dentistry

Pelotas, Rio Grande do Sul, 96015560, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Bruxism

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Marilia L Goettems, PhD

CONTACT

555332256741; mariliagoettems@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: September 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: May 1, 2021
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

BR (1)