UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000035596
Receipt number R000040559
Scientific Title The study of the effective tongue movement methods as functional oral rehabilitation
Date of disclosure of the study information 2019/01/20
Last modified on 2024/01/23 10:57:26

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Basic information

Public title

The study of the effective tongue movement methods as functional oral rehabilitation

Acronym

The study of the functional oral rehabilitation by tongue movement

Scientific Title

The study of the effective tongue movement methods as functional oral rehabilitation

Scientific Title:Acronym

The study of the functional oral rehabilitation by tongue movement

Region

Japan


Condition

Condition

Oral hypofunction

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to determine whether some kinds of tongue movements are effective for improving the oral hypofunction among the elderly people.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

tongue pressure

Key secondary outcomes

Dry mouth condition
Speaking function
Lips pressure
etc


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

The group 1 is to do tongue exercise which the tongue tip push up the palatal lid direction 5 times. Intervention is performed twice a day.

Interventions/Control_2

The group 2 is to do tongue exercise which the tongue tip touch the behind of lips and turn around right and left each 5 times. Intervention is performed twice a day.

Interventions/Control_3

The group 3 is to do tongue exercise which the tongue tip touch the right and left buccal mucosa and turn around each 5 times. Intervention is performed twice a day.

Interventions/Control_4

Control group is not given any instructs.

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

1)Dental outpatients
2)Oral hypofunction

Key exclusion criteria

1)The elderly who staying in nursing homes or hospitals
2)Having oral cancer,
3)Received intraoral radiation therapy at any time in the past
4)Having salivary gland disease.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Mami
Middle name
Last name Endoh

Organization

Nihon university dentistry at Matsudo

Division name

Department of special needs dentistry

Zip code

271-8587

Address

2-870-1, Sakae cho- nishi, Matsudo City, Chiba prefecture, Japan

TEL

09030428130

Email

endoh.mami@nihon-u.ac.jp


Public contact

Name of contact person

1st name Mami
Middle name
Last name Endoh

Organization

Nihon university dentistry at Matsudo

Division name

Department of special needs dentistry

Zip code

271-8587

Address

2-870-1, Sakae cho- nishi, Matsudo City, Chiba prefecture, Japan

TEL

09030428130

Homepage URL


Email

endoh.mami@nihon-u.ac.jp


Sponsor or person

Institute

Nihon university dentistry at Matsudo, Department of special needs dentistry

Institute

Department

Personal name



Funding Source

Organization

Nihon university dentistry at Matsudo, Department of special needs dentistry

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Nihon University School of Dentistry at Matsudo

Address

2-870-1, Sakae cho- nishi, Matsudo City, Chiba prefecture, Japan

Tel

0473609274

Email

endoh.mami@nihon-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

朝田歯科医院(東京都)


Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 20 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

Enrolling by invitation

Date of protocol fixation

2018 Year 10 Month 10 Day

Date of IRB

2019 Year 02 Month 28 Day

Anticipated trial start date

2019 Year 01 Month 27 Day

Last follow-up date

2024 Year 02 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 19 Day

Last modified on

2024 Year 01 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040559


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name