<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/NCT04407455</url>
  </required_header>
  <id_info>
    <org_study_id>Chewing performance level</org_study_id>
    <nct_id>NCT04407455</nct_id>
  </id_info>
  <brief_title>Determining Chewing Performance Level in Children</brief_title>
  <official_title>Inter-rater Reliability in Determining Chewing Performance Level in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</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 study will investigate to verify whether pediatric dentists could determine chewing&#xD;
      performance level by using Karaduman Chewing Performance Scale in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The KCPS was developed by physical therapists who had expertise in pediatric swallowing&#xD;
      disorders. This scale could be used as a practical tool to define chewing disorders as a&#xD;
      common language for professionals due to its quick and easy to use features. However, its&#xD;
      reliability in other professions has not been verified. The study will investigate to verify&#xD;
      whether pediatric dentists could determine chewing performance level by using Karaduman&#xD;
      Chewing Performance Scale in children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2020</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Karaduman Chewing Performance Scale</measure>
    <time_frame>2 months</time_frame>
    <description>The Karaduman Chewing Performance Scale is a 5 level ordinal scale between 0 to 4. Level 0 indicates Normal chewing, level 4 means No biting and chewing. Higher levels mean worse chewing performance level.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">97</enrollment>
  <condition>Chewing Problem</condition>
  <arm_group>
    <arm_group_label>Children with cerebral palsy</arm_group_label>
    <description>Children who will be referred to pediatric dentistry above the age of 2 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children with typical development</arm_group_label>
    <description>Children who will be referred to pediatric dentistry above the age of 2 years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Karaduman Chewing Performance Scale</intervention_name>
    <description>For chewing evaluation, children will be asked to bite and chew a standardized biscuit. Each chewing evaluation will be scored according to the KCPS.</description>
    <arm_group_label>Children with cerebral palsy</arm_group_label>
    <arm_group_label>Children with typical development</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Typical developing children and children with cerebral palsy (CP) who will be referred to&#xD;
        pediatric dentistry above the age of 2 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Typical developing children&#xD;
&#xD;
          -  Children with cerebral palsy (CP)&#xD;
&#xD;
          -  Above the age of 2 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who were under the age of 2 years&#xD;
&#xD;
          -  Who used any medicine and/or oral appliances that may affect chewing performance&#xD;
&#xD;
          -  Who had a previous evaluation of chewing function and received any chewing training&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>SELEN SEREL ARSLAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacetttepe University</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>SELEN SEREL ARSLAN</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04407455
org study id: Chewing performance level
nct id: NCT04407455
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will investigate to verify whether pediatric dentists could determine chewing
      performance level by using Karaduman Chewing Performance Scale in children.
The KCPS was developed by physical therapists who had expertise in pediatric swallowing
      disorders. This scale could be used as a practical tool to define chewing disorders as a
      common language for professionals due to its quick and easy to use features. However, its
      reliability in other professions has not been verified. The study will investigate to verify
      whether pediatric dentists could determine chewing performance level by using Karaduman
      Chewing Performance Scale in children.
observational model: Cohort
time perspective: Prospective
measure: Karaduman Chewing Performance Scale
time frame: 2 months
description: The Karaduman Chewing Performance Scale is a 5 level ordinal scale between 0 to 4. Level 0 indicates Normal chewing, level 4 means No biting and chewing. Higher levels mean worse chewing performance level.
arm group label: Children with cerebral palsy
description: Children who will be referred to pediatric dentistry above the age of 2 years.
arm group label: Children with typical development
description: Children who will be referred to pediatric dentistry above the age of 2 years.
intervention type: Diagnostic Test
intervention name: Karaduman Chewing Performance Scale
description: For chewing evaluation, children will be asked to bite and chew a standardized biscuit. Each chewing evaluation will be scored according to the KCPS.
arm group label: Children with cerebral palsy
arm group label: Children with typical development
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
last name: SELEN SEREL ARSLAN
role: Principal Investigator
affiliation: Hacettepe University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: SELEN SEREL ARSLAN
investigator title: Principal Investigator
sharing ipd: No