UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028780
Receipt number R000032930
Scientific Title Association between texture sensation in tongue and atrophy of lingual papillae
Date of disclosure of the study information 2018/08/23
Last modified on 2023/09/01 20:47:52

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Basic information

Public title

Association between texture sensation in tongue and atrophy of lingual papillae

Acronym

Texture sensation and atrophy of lingual papillae

Scientific Title

Association between texture sensation in tongue and atrophy of lingual papillae

Scientific Title:Acronym

Texture sensation and atrophy of lingual papillae

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of atrophy of lingual papillae on texture sensation in the tongue.

Basic objectives2

Others

Basic objectives -Others

To clarify the type of texture of which therecognition threshold value increase as the lingual papillae become atrophic.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation between the anatomical index of lingual papillae and the recognition threshold of texture sensation.

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

Diagnosis

Type of intervention

Other

Interventions/Control_1

Impression taking of tongue surface. Measuring the recognition threshold value of texture sensation of tongue. Measuring the mechanical detection threshold value of tongue.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Subjects 18 years of age or older.
(2) Written informed consent to participate as a subject in this study.

Key exclusion criteria

(1) Subjects who have pain or sensory impairment in the stomatognathic system.
(2) Subjects who have movement impairment in the stomatognathic system.
(3) Subjects who suffer from a nervous disorder.
(4) Subjects who have allergy to test foods.
(5) Subjects who excite a choke refkex by touch stimulus at dorsum of tongue.
(6) Subjects who have difficulty swallowing.

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Yoshinori
Middle name
Last name Hattori

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Aging and Geriatric Dentistry

Zip code

9808575

Address

4-1, Seiryo-machi, Aobaku, Sendai-city, Miyagi JAPAN

TEL

022-717-8396

Email

yoshinori.hattori.b4@tohoku.ac.jp


Public contact

Name of contact person

1st name Yasue
Middle name
Last name Tanaka

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Aging and Geriatric Dentistry

Zip code

9808575

Address

4-1, Seiryo-machi, Aobaku, Sendai-city, Miyagi JAPAN

TEL

022-717-8396

Homepage URL


Email

yasue.tanaka.b3@tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Tohoku 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

Ethics Committee Tohoku University Graduate School of Dentistry

Address

4-1 Seiryo-machi, Aoba-ku, Sendai

Tel

022-717-8244

Email

den-syom@grp.tohoku.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

2018 Year 08 Month 23 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

10

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

Completed

Date of protocol fixation

2016 Year 04 Month 27 Day

Date of IRB

2017 Year 08 Month 22 Day

Anticipated trial start date

2018 Year 08 Month 23 Day

Last follow-up date

2023 Year 08 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

2017 Year 08 Month 22 Day

Last modified on

2023 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032930


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name