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
CRIS Registration Number |
KCT0005962 |
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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
Board Approval Status | Submitted approval |
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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 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 | 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
1. Source of Monetary/Material Support | |
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Organization Name | Dankook University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Dankook University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
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)
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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2022. 2 |
Way of Sharing | Available on Request
(jhj@dankook.ac.kr) |
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