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
CRIS Registration Number |
KCT0005914 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Dankook University |
Organization Type | University |
Project ID | R201900806 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Dankook University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (Z00-Z99)Factors influencing health status and contact with health services (Z01.2)Dental examination Communications Personnel / Dental caries |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered |
Yes
Results Upload |
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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 Statement | Yes |
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Time of Sharing | 2021. 12 |
Way of Sharing | Available on Request
(jhj@dankook.ac.kr) |
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