UMIN-CTR Clinical Trial

Basic information
Public title	Verification of salivary secretion promoting effect by orally disintegrating film.
Acronym	Verification of salivary secretion promoting effect by orally disintegrating film.
Scientific Title	Verification of salivary secretion promoting effect by orally disintegrating film.
Scientific Title:Acronym	Verification of salivary secretion promoting effect by orally disintegrating film.
Region	Japan

Condition
Condition	Elderly people with suspected decrease in salivary secretion due to aging
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the salivary secretion-promoting effect of the orally disintegrating film containing sodium L-glutamate.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	An amount of saliva produced at rest before the start of the study. An amount of saliva after ingesting the orally disintegrating film at the start of study. An amount of saliva produced at rest on the 14th day of the study. An amount of saliva after ingesting the orally disintegrating on the 14th day of the study.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intervention period 14days Intervention frequency Ingest 6 orally disintegrating film a day, 2 in the morning, 2 in the afternoon and 2 in the evening, for 14 days.
Interventions/Control_2
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Elderly people 65 years and older, 10 men and 10 women, whose salivary secretion is expected to decrease due to aging. Those who have received sufficient explanation before participating in this study and who have agreed to participate in the study.
Key exclusion criteria	Subjects who have difficulty communicating. Subjects who cannot ingest the film continuously during the study period due to deterioration of cognitive function or judgment ability.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Haruka Middle name Last name Tohara
Organization	Tokyo Medical and Dental University
Division name	Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences
Zip code	113-8549
Address	1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
TEL	03-5803-5559
Email	harukatohara@hotmail.com

Public contact
Name of contact person	1st name Haruka Middle name Last name Tohara
Organization	Tokyo Medical and Dental University
Division name	Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences
Zip code	113-8549
Address	1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
TEL	03-5803-5559
Homepage URL
Email	harukatohara@hotmail.com

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University, faculty of dentistry
Address	1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
Tel	03-5803-5404
Email	d-hyoka.adm@tmd.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 04 Month 01 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
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	Terminated
Date of protocol fixation	2020 Year 03 Month 23 Day
Date of IRB	2020 Year 07 Month 13 Day
Anticipated trial start date	2020 Year 05 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 28 Day
Last modified on	2021 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044816