Sleep Hygiene Measures for Sleep Bruxism in Children

NCT ID: NCT04501237

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bruxers without sleep hygiene instructions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Bruxers with sleep hygiene instructions

Group Type: EXPERIMENTAL

Bruxers with sleep hygiene instructions

Intervention Type: BEHAVIORAL

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

Interventions

Bruxers with sleep hygiene instructions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Pelotas

OTHER

Sponsor Role: lead

Responsible Party

Maximiliano Sergio Cenci

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of dentistry

Pelotas, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Marilia L Goettems, PhD

Role: CONTACT

mariliagoettems@gmail.com

555332256741

Facility Contacts

MArilia L Goettems, PhD

Role: primary

mariliagoettems@gmail.com

555332256741

Other Identifiers

PPGO 032

Identifier Type: -

Identifier Source: org_study_id