Sleep Hygiene Measures for Sleep Bruxism in Children
Primary Purpose
Sleep Bruxism, Childhood
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bruxers with sleep hygiene instructions
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Bruxism, Childhood
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.
Sites / Locations
- School of dentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Bruxers without sleep hygiene instructions
Bruxers with sleep hygiene instructions
Arm Description
Outcomes
Primary Outcome Measures
Questionnaire
Strengths and Difficulties Questionnaire
Secondary Outcome Measures
Clinical evaluation of child teeth
Basic Erosive Wear Examination Index
Full Information
NCT ID
NCT04501237
First Posted
August 3, 2020
Last Updated
August 3, 2020
Sponsor
Federal University of Pelotas
1. Study Identification
Unique Protocol Identification Number
NCT04501237
Brief Title
Sleep Hygiene Measures for Sleep Bruxism in Children
Official Title
Efficacy of Sleep Hygiene Measures in the Occurrence of Sleep Bruxism in Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Pelotas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Bruxism, Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bruxers without sleep hygiene instructions
Arm Type
No Intervention
Arm Title
Bruxers with sleep hygiene instructions
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Bruxers with sleep hygiene instructions
Intervention Description
the test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio.
Primary Outcome Measure Information:
Title
Questionnaire
Description
Strengths and Difficulties Questionnaire
Time Frame
Responded 1 month after intervention in both groups
Secondary Outcome Measure Information:
Title
Clinical evaluation of child teeth
Description
Basic Erosive Wear Examination Index
Time Frame
Analyzed 1 month after intervention in both groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marilia L Goettems, PhD
Phone
555332256741
Email
mariliagoettems@gmail.com
Facility Information:
Facility Name
School of dentistry
City
Pelotas
State/Province
RS
ZIP/Postal Code
96015560
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MArilia L Goettems, PhD
Phone
555332256741
Email
mariliagoettems@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Sleep Hygiene Measures for Sleep Bruxism in Children
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