UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035005
Receipt number R000039913
Scientific Title A clinical study of taste sensitivities using taste tests in children.
Date of disclosure of the study information 2019/02/15
Last modified on 2023/11/30 09:36:13

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Basic information

Public title

A clinical study of taste sensitivities using taste tests in children.

Acronym

A clinical study of taste sensitivities using taste tests in children.

Scientific Title

A clinical study of taste sensitivities using taste tests in children.

Scientific Title:Acronym

A clinical study of taste sensitivities using taste tests in children.

Region

Japan


Condition

Condition

Dysgeusia

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate taste sensitivities using taste tests in children

Basic objectives2

Others

Basic objectives -Others

Usability

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

taste sensitivities

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Taste tests (The instillation method,Electrogustometry:EGM), Saxon test
One time

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

4 years-old <=

Age-upper limit

12 years-old >=

Gender

Male and Female

Key inclusion criteria

Outpatients treated at the department pediatric dentistry, Nagasaki university hospital

Key exclusion criteria

Patients regarded as ineligible by principal investigator

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Rie
Middle name
Last name Fujiyama

Organization

Nagasaki University Graduate School of Biomedical Science

Division name

Department for Clinical Education in General Dentistry

Zip code

8528588

Address

Sakamoto 1-7-1, Nagasaki city, Nagasaki, Japan

TEL

095-819-7760

Email

rierika@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Rie
Middle name
Last name Fujiyama

Organization

Nagasaki University Graduate School of Biomedical Science

Division name

Department for Clinical Education in General Dentistry

Zip code

8528588

Address

Sakamoto 1-7-1, Nagasaki city, Nagasaki, Japan

TEL

095-819-7760

Homepage URL


Email

rierika@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

JSPS

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Graduate School of Biomedical Science

Address

Sakamoto 1-7-1, Nagasaki city, Nagasaki, Japan

Tel

095-819-7760

Email

rierika@nagasaki-u.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

長崎大学病院(長崎県)


Other administrative information

Date of disclosure of the study information

2019 Year 02 Month 15 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

Delay expected

Results Delay Reason

Due to outpatient restrictions and other factors caused by the spread of corona infection.

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

Open public recruiting

Date of protocol fixation

2019 Year 01 Month 25 Day

Date of IRB

2019 Year 01 Month 22 Day

Anticipated trial start date

2019 Year 01 Month 31 Day

Last follow-up date

2025 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

2018 Year 11 Month 26 Day

Last modified on

2023 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039913


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name