UMIN-CTR Clinical Trial

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
Email	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
Email	ssjs.takenouchi@gmail.com

Sponsor
Institute	Lotte Co., Ltd
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048814