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One-side author of the author and habits of comparative study on work and work efficiency

Status Approved

  • First Submitted Date

    2021/02/25

  • Registered Date

    2021/03/05

  • Last Updated Date

    2021/02/25

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005962
    Unique Protocol ID DKU 2016-10-014
    Public/Brief Title Work and work efficiency
    Scientific Title One-side author of the author and habits of comparative study on work and work efficiency
    Acronym WWE
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number DKU 2016-10-014
    Approval Date 2016-11-10
    Institutional Review Board Name Dankook University Institutional Review Board
    Institutional Review Board Address #433, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungcheongnam-do
    Institutional Review Board Telephone 041-550-1058
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jong-Hwa Jang
    Title professor
    Telephone +82-41-550-1495
    Affiliation Dankook University
    Address 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam, 31116, Korea
    Contact Person for Public Queries
    Name Jong-Hwa Jang
    Title professor
    Telephone +82-41-550-1495
    Affiliation Dankook University
    Address 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam, 31116, Korea
    Contact Person for Updating Information
    Name Jong-Hwa Jang
    Title professor
    Telephone +82-41-550-1495
    Affiliation Dankook University
    Address 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam, 31116, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2016-11-10 Actual
    Target Number of Participant 50
    Primary Completion Date 2016-11-10 , Actual
    Study Completion Date 2017-11-09 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Dankook University
    Recruitment Status Completed
    Date of First Enrollment 2016-11-10 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Dankook University
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Dankook University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This study comparatively analyzed whether there is a significant difference in
    masticatory performance and masticatory efficiency between bilateral masticators
    and habitual unilateral masticators and then inquired into whether there is a
    significant difference in masticatory performance and masticatory efficiency when
    leading habitual unilateral masticators into bilateral chewing for a certain period 
    of time.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Prevention
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation Non-RCT
    Intervention Type Behavioral  
    Intervention Description
    1. Unilateral masticatory group
    1) Measurement of masticatory performance and masticatory efficiency
     -After the 1st crushed sample measurement experiment was conducted, 21 1g xylitol gums were provided each for 2 weeks before the 2nd crushed sample measurement method was performed, 3 times a day for breakfast, lunch and dinner, and mastication exercise and food on the non-macrostic side for 30 minutes. Practice of bilateral mastication when ingested.
    -The experiment before bilateral mastication induction and the experiment after bilateral induction were repeated twice.
    -Regardless of left and right, the main authoring side and the non-masticatory side are each implemented in the same way.
    
    2. Bilateral masticatory group (control group)
    -Participate once in the same way as one-sided masticatory group
    Number of Arms 2
    Arm 1

    Arm Label

    Unilateral masticatory group

    Target Number of Participant

    25

    Arm Type

    Experimental

    Arm Description

    1. Measurement of masticatory performance and masticatory efficiency
     -After the 1st crushed sample measurement experiment was conducted, 21 1g xylitol gums were provided each for 2 weeks before the 2nd crushed sample measurement method was performed, 3 times a day for breakfast, lunch and dinner, and mastication exercise and food on the non-macrostic side for 30 minutes. Practice of bilateral mastication when ingested.
    -The experiment before bilateral mastication induction and the experiment after bilateral induction were repeated twice.
    -Regardless of left and right, the main authoring side and the non-masticatory side are each implemented in the same way.
    Arm 2

    Arm Label

    Bilateral masticatory group (control group)

    Target Number of Participant

    25

    Arm Type

    Active comparator

    Arm Description

    -Participate once in the same way as one-sided masticatory group
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s)    Not Applicable-Etc 

    Healthy adults / Mastication disability
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~30Year

    Description

    1. Those who do not have lost teeth in the oral cavity
    2. Those who do not wear orthodontic devices
    3. Those whose third molar teeth do not occlude
    Exclusion Criteria
    1. Those with lost teeth in the oral cavity
    2. Orthodontic device wearer
    3. Those with occlusal third molar teeth
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    masticatory performance
    Timepoint
    pre-test, post-test(after 2 weeks)
    Primary Outcome(s) 2
    Outcome
    masticatory efficiency
    Timepoint
    pre-test, post-test(after 2 weeks)
    Primary Outcome(s) 3
    Outcome
    Main mastication direction
    Timepoint
    Baseline survey
    Secondary Outcome(s) 1
    Outcome
    Demographic characteristics (sex, age)
    Timepoint
    Baseline survey
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2022. 2
    Way of Sharing Available on Request
    (jhj@dankook.ac.kr)
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