<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04501237</url>
  </required_header>
  <id_info>
    <org_study_id>PPGO 032</org_study_id>
    <nct_id>NCT04501237</nct_id>
  </id_info>
  <brief_title>Sleep Hygiene Measures for Sleep Bruxism in Children</brief_title>
  <official_title>Efficacy of Sleep Hygiene Measures in the Occurrence of Sleep Bruxism in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Pelotas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Pelotas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the efficacy of sleep hygiene measures for the possible&#xD;
      improvement of sleep bruxism in children through a randomized controlled clinical study of&#xD;
      children under 8 years of age with probable sleep bruxism. In randomization both groups will&#xD;
      receive information about bruxism, and the test group will receive instructions of sleep&#xD;
      hygiene, limited use of screens and a relaxation audio. The occurrence of sleep bruxism will&#xD;
      be assessed through a diary to be completed by the child's responsible party. A randomized,&#xD;
      stratified sample of approximately 16 children will be included in the study. One group will&#xD;
      be composed of 8 children with probable sleep bruxism who will receive the sleep hygiene&#xD;
      intervention, and another group of children who will only receive instructions on sleep&#xD;
      bruxism, with causes and consequences. Participants will be followed-up for 30 days. Parents&#xD;
      will respond to a questionnaire about socioeconomic, demographic (child's age and gender), as&#xD;
      well as parafunctional habits such as nail biting, biting objects, pacifier sucking, finger /&#xD;
      thumb sucking and bottle feeding, child's sleep characteristics, screen habits, parental&#xD;
      smoking, problems breathing, parental profession and also on psychological issues. Sleep&#xD;
      habits will also be answered in this questionnaire, and parents will also answer the&#xD;
      Strengths and Difficulties Questionnaire. The children over 6 years old will respond a Child&#xD;
      Stress Scale and the Child of stressing sources in child; children less than 6 years will&#xD;
      have the questionnaire responded by parents. The children will undergo a clinical examination&#xD;
      to assess dental wear, according to the BEWE (Basic Erosive Wear Examination Index). The&#xD;
      study evaluations consist of baseline, 1, 7, 15 and 30 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>Responded 1 month after intervention in both groups</time_frame>
    <description>Strengths and Difficulties Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical evaluation of child teeth</measure>
    <time_frame>Analyzed 1 month after intervention in both groups</time_frame>
    <description>Basic Erosive Wear Examination Index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Sleep Bruxism, Childhood</condition>
  <arm_group>
    <arm_group_label>Bruxers without sleep hygiene instructions</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Bruxers with sleep hygiene instructions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Bruxers with sleep hygiene instructions</intervention_name>
    <description>the test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio.</description>
    <arm_group_label>Bruxers with sleep hygiene instructions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children with probable sleep bruxism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic diseases;&#xD;
&#xD;
          -  Medical and/or behavioral conditions that requires special considerations regarding&#xD;
             management/treatment of the child.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marilia L Goettems, PhD</last_name>
    <phone>555332256741</phone>
    <email>mariliagoettems@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>School of dentistry</name>
      <address>
        <city>Pelotas</city>
        <state>RS</state>
        <zip>96015560</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MArilia L Goettems, PhD</last_name>
      <phone>555332256741</phone>
      <email>mariliagoettems@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Pelotas</investigator_affiliation>
    <investigator_full_name>Maximiliano Sergio Cenci</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bruxism</mesh_term>
    <mesh_term>Sleep Bruxism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04501237
org study id: PPGO 032
nct id: NCT04501237
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Questionnaire
time frame: Responded 1 month after intervention in both groups
description: Strengths and Difficulties Questionnaire
measure: Clinical evaluation of child teeth
time frame: Analyzed 1 month after intervention in both groups
description: Basic Erosive Wear Examination Index
arm group label: Bruxers without sleep hygiene instructions
arm group type: No Intervention
arm group label: Bruxers with sleep hygiene instructions
arm group type: Experimental
intervention type: Behavioral
intervention name: Bruxers with sleep hygiene instructions
description: the test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio.
arm group label: Bruxers with sleep hygiene instructions
criteria: 
gender: All
minimum age: 2 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marilia L Goettems, PhD
phone: 555332256741
email: mariliagoettems@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Pelotas
investigator full name: Maximiliano Sergio Cenci
investigator title: Professor
mesh term: Bruxism
mesh term: Sleep Bruxism
sharing ipd: Undecided