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Development and effectiveness of oral health education for preschool children program

Status Approved

  • First Submitted Date

    2021/02/07

  • Registered Date

    2021/02/19

  • Last Updated Date

    2021/02/07

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
    KCT0005914
    Unique Protocol ID DKU 2018-09-025-001
    Public/Brief Title ORAL HEALTH INTERVENTION PROGRAM ON THE SELF ORAL CARE OF CHILDREN
    Scientific Title Development and effectiveness of oral health education for preschool children program
    Acronym 유사실험연구
    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 2018-09-025-001
    Approval Date 2018-10-24
    Institutional Review Board Name Dankook university Institutional Review Board
    Institutional Review Board Address 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam, 31116, Korea
    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 2018-10-24 Actual
    Target Number of Participant 64
    Primary Completion Date 2018-11-25 , Actual
    Study Completion Date 2019-01-24 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Dankook University
    Recruitment Status Completed
    Date of First Enrollment 2018-10-24 ,
  • 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 R201900806
  • 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 aimed to conduct a quasi-experimental study for assessing the effects of an oral health intervention program (OHIP), on the self-management of oral health in children attending childcare centers. We recruited 83 children from two childcare centers and allocated them to the intervention and control groups. Those in the former group received OHIP. We conducted a self-reported survey of the parents at baseline. Furthermore, we evaluated the oral conditions of the children at baseline and 4 weeks later. Their brushing behavior was assessed once a week and every day during the OHIP intervention period and at home, respectively. We measured the dental plaque index (PI) after a 12-week follow-up and performed a repeated measures ANOVA analysis. The PI of the intervention group significantly decreased at week 4, compared to the baseline (1.90 ± 0.53, P < 0.001). Despite a substantial increase in week 12 (2.67 ± 0.08,  P < 0.001), PI was significantly lower than that of the control group (3.37 ± 0.60). OHIP was effective in reducing the PI and modifying the brushing behavior among children. Therefore, it is necessary to develop and expand a systematic oral health education program to promote self-management of oral health in children.
  • 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
    Others
    (ORAL HEALTH INTERVENTION PROGRAM)
    Phase Not applicable
    Intervention Model Others (quasi-experimental study with a non-equivalent control group, pretest-posttest)
    Blinding/Masking Open
    Allocation Non-RCT
    Intervention Type Behavioral  
    Intervention Description
    1. intervention group
    - audio-visual education on oral health for less than 15 minutes, once a week, for 4 weeks. 
    - The participants practised brushing their teeth while watching a music video ”Let’s Brush Our Teeth as We Sing” every day after lunch in the centers. 
    
    2. control group
    - similar oral health education as the intervention group, 12 weeks after the completion of the follow-up.
    Number of Arms 1
    Arm 1

    Arm Label

    intervention group

    Target Number of Participant

    32

    Arm Type

    Experimental

    Arm Description

    - We also provided audio-visual education on oral health for less than 15 minutes, once a week, for 4 weeks. 
    - The participants practised brushing their teeth while watching a music video ”Let’s Brush Our Teeth as We Sing” every day after lunch in the centers.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (Z00-Z99)Factors influencing health status and contact with health services 
       (Z01.2)Dental examination 

    Communications Personnel / Dental caries
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    3Year~6Year

    Description

    -Preschool children aged 3-6 years attending kindergartens, day care centers and childcare facilities
          -Early school age children whose parents have agreed to the research agreement
          -Preschool children without systemic disease
          -Preschool children who can communicate
    Exclusion Criteria
    -Children under 3 years of age before school age
          -Children between 3 and 5 years of age before school age who do not attend kindergartens, day care centers and daycare
          -Early school age children whose parents do not agree to the research agreement
          -Preschool children with systemic diseases
          -Children of the preschool age who cannot communicate
    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
    dental plaque index
    Timepoint
    Pre / Post (after 4 weeks) / Follow-up (after 12 weeks)
    Secondary Outcome(s) 1
    Outcome
    brushing behavior
    Timepoint
    Pre / Post (after 4 weeks) / Follow-up (after 12 weeks)
  • 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 Yes
    Results Upload
    Final Enrollment Number 83
    Number of Publication 0
    Results Upload Manuscript_final.pdf
    Date of Posting Results 2021/02/19
    Protocol URL or File Upload Manuscript_final1.pdf
    Brief Summary
    - The PI of the intervention group significantly decreased at week 4, compared to the baseline (1.90 ± 0.53, P < 0.001). Despite a substantial increase in week 12 (2.67 ± 0.08,  P < 0.001), PI was significantly lower than that of the control group (3.37 ± 0.60). 
    - OHIP was effective in reducing the PI and modifying the brushing behavior among children. Therefore, it is necessary to develop and expand a systematic oral health education program to promote self-management of oral health in children.
  • 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 2021. 12
    Way of Sharing Available on Request
    (jhj@dankook.ac.kr)
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