臨床研究等提出・公開システム

Date of registration	Oct. 01, 2021
Last modified on	Oct. 01, 2021
Trial ID	jRCT1060210036

Scientific Title	Effects of tastant on salivation flow.
Public Title	Effects of tastant on salivation flow.

Contact for Scientific Queries	Name	HIKARU SUGIMOTO
	Affiliation	Okayama University Hospital
	Address	2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama
	Telephone	+81-862356687
	E-mail	sugimoto.hika@s.okayama-u.ac.jp
Contact for Public Queries	Name	HIKARU SUGIMOTO
	Affiliation	Okayama University Hospital
	Address	2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama
	Telephone	+81-862356687
	E-mail	sugimoto.hika@s.okayama-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 01, 2021
Target sample size		22
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy adults over 20 years old of Okayama University School of Dentistry and staff members of Okayama University Hospital
	Exclusion Criteria	Persons with a history of chemotherapy and radiation therapy for endocrine, immunological disease, liver damage, kidney damage or head and neck cancer and cold and Zinc deficiency and Those receiving medication that may have a direct effect on thirst and those who have saliva of 2g or less when stimulating the Saxon test.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Xerostomia
Intervention(s)		Sustained administration of tastant.The taste solutions are monosodium inosinate, monosodium glutamate, aspartame, sucralose, and acesulfame K. A very small amount of each solution(0.04ml/min) is dropped into the oral cavity for 120 minutes.
Health Condition(s) Keyword		Xerostomia
Primary Outcome(s)		Changes in saliva flow over time.
Secondary Outcome(s)		Subjective evaluation of taste intensity

Primary Sponsor	Okayama University Hospital

Secondary Sponsor

Name of Certified Review Board	Okayama University Ethics Review Committee
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama
Telephone	+81-862356938
E-Mail	mae6605@adm.okayama-u.ac.jp
Approval Status	Approval
Date of approval	Aug. 24, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none