UMIN-CTR Clinical Trial

Public title

Effect of taste on salivary secretion

Acronym

Effect of taste on salivary secretion

Scientific Title

Effect of taste on salivary secretion

Scientific Title:Acronym

Effect of taste on salivary secretion

Region

Japan

Condition

saliva

Classification by specialty

Dental medicine

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Effects of tastants on long-term saliva outflow

Basic objectives2

Others

Basic objectives -Others

Increased salivary outflow due to taste substances

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Saliva outflow is affected by tastants.

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

After gelling purified water and filling it into the depression, it is placed in the oral cavity for 3 hours each in the morning and afternoon, and the saliva outflow is observed every 10 minutes by the spit method.

Interventions/Control_2

After gelling NaCl and filling it into the depression, it is placed in the oral cavity for 3 hours each in the morning and afternoon, and the saliva outflow is observed every 10 minutes by the spit method.

Interventions/Control_3

After gelling Sodium glutamate and filling it into the depression, it is placed in the oral cavity for 3 hours each in the morning and afternoon, and the saliva outflow is observed every 10 minutes by the spit method.

Interventions/Control_4

After gelling glucose and filling it into the depression, it is placed in the oral cavity for 3 hours each in the morning and afternoon, and the saliva outflow is observed every 10 minutes by the spit method.

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

100

years-old

>=

Gender

Male and Female

Key inclusion criteria

Healthy adult

Key exclusion criteria

Systemic disease:endocrine, immunological, or history of chemotherapy and radiation therapy for head and neck cancer. Those who are on medications that may directly affect dry mouth. Person with saliva less than 1 ml at rest for 10 minutes. Those whose saliva is 2g or less when stimulated by the Saxon test.

Target sample size

10

Name of lead principal investigator

1st name	YUKI
Middle name
Last name	TANAKA

Organization

Okayama University Graduate School of Biomedical Sciences

Division name

Occlusion and Denture Prosthesis

Zip code

7008525

Address

Okayama Prefecture Okayama City Kita Ward Shikata-cho 2-5-1

TEL

0862356687

Email

yukitanaka@s.okayama-u.ac.jp

Name of contact person

1st name	YUKI
Middle name
Last name	TANAKA

Organization

Okayama University Graduate School of Biomedical Sciences

Division name

Occlusion and Denture Prosthesis

Zip code

7008525

Address

Okayama Prefecture Okayama City Kita Ward Shikata-cho 2-5-1

TEL

0862356687

Homepage URL

Email

yukitanaka@s.okayama-u.ac.jp

Institute

Okayama University

Institute

Department

Personal name

Organization

Okayama University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Okayama University Ethics Review Committee Secretariat

Address

Okayama Prefecture Okayama City Kita Ward Shikata-cho 2-5-1

Tel

0862356938

Email

mae6605@adm.okayama-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岡山大学病院岡山大学大学院医歯薬学総合研究科
咬合・有床義歯補綴学分野

Date of disclosure of the study information

2020

Year

08

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

5

Results

When an intervention study was conducted on five subjects, contrary to the expected results, no increase in saliva secretion was observed with any of the test taste solutions. The test results were different from past reports. The possible cause was that the concentration set by the supply device could not be maintained and the threshold required for increased saliva secretion was not reached.

Results date posted

2023

Year

10

Month

02

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Healthy adults who do not have dry mouth (Saxon test and resting saliva method are used for screening)

Participant flow

Subjects were recruited according to a protocol approved by the Okayama University Clinical Research Ethics Review Committee, and the research protocol was implemented after obtaining consent.

Adverse events

nothing special

Outcome measures

saxon test
Resting saliva method
increase in saliva

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2020

Year

08

Month

14

Day

Date of IRB

2020

Year

09

Month

10

Day

Anticipated trial start date

2020

Year

08

Month

31

Day

Last follow-up date

2023

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

08

Month

14

Day

Last modified on

2023

Year

10

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047188