UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042770 |
|---|---|
| Receipt number | R000048814 |
| Scientific Title | Evaluation study of the effects of mastication on oral and general health |
| Date of disclosure of the study information | 2020/12/16 |
| Last modified on | 2022/07/11 09:18:55 |
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Basic information
Public title
Effects of mastication on oral and systemic health
Acronym
Mastication health function evaluation study
Scientific Title
Evaluation study of the effects of mastication on oral and general health
Scientific Title:Acronym
Mastication saliva evaluation study
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study is to evaluate the effect of mastication on oral and systemic health by analyzing the salivary components with metabolomics, the salivary flow rate, the oral hygiene, the masticatory function and the s-IgA changes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Between the chewing group and the the non-chewing group, the changes of saliva metabolome and salivary flow rate are compared and evaluated 4 weeks after intervention.
The chewing group chews the gum base (7 times / day, about 10 minutes / time, 4 weeks), and the non-chewing group is prohibited from chewing for 4 weeks.
Key secondary outcomes
Between the chewing group and the the non-chewing group, the changes of oral hygiene, masticatory function and s-IgA analysis are compared and evaluated 4 weeks after intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The chewing group chews the gum base (7 times / day, about 10 minutes / time) for 4 weeks.
Interventions/Control_2
The non-chewing group is prohibited from chewing for 4 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students who agree with this study
Key exclusion criteria
Those who have systemic disease, are under dental treatments, are taking medication regularly, are chewing gum frequently.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akane |
| Middle name | |
| Last name | Takenouchi |
Organization
Shinjuku Medical Career College
Division name
Dental Hygiene Course
Zip code
160-0017
Address
5, Samon-cho, Shinjuku-ku, Tokyo
TEL
03-3357-6811
ssjs.takenouchi@gmail.com
Public contact
Name of contact person
| 1st name | Akane |
| Middle name | |
| Last name | Takenouchi |
Organization
Shinjuku Medical Career College
Division name
Dental Hygiene Course
Zip code
160-0017
Address
5, Samon-cho, Shinjuku-ku, Tokyo
TEL
03-3357-6811
Homepage URL
ssjs.takenouchi@gmail.com
Sponsor or person
Institute
Lotte Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Shinjuku Medical Career College
Address
5, Samon-cho, Shinjuku-ku, Tokyo
Tel
03-3357-6811
tonegawa@ssjs.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
82
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 16 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 16 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 16 | Day |
Last modified on
| 2022 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048814
