UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048830
Receipt number R000055643
Scientific Title Relationship between Masticatory function and Cognitive function in patients with dementia
Date of disclosure of the study information 2022/09/02
Last modified on 2022/09/02 12:41:57

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Basic information

Public title

Chewing and Brain function -Comparison for the type of Dementia-

Acronym

Chewing and Brain function

Scientific Title

Relationship between Masticatory function and Cognitive function in patients with dementia

Scientific Title:Acronym

Relationship between Masticatory function and Cognitive function

Region

Japan


Condition

Condition

Lewy body disease / Alzheimer's disease

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In order to clarify the effect of masticatory intervention on cognitive function in dementia patients, the aim of this study is to analyze the relationship between masticatory function and cognitive function in patients with dementia with Lewy body disease (LBD) and Alzheimer's disease (AD) diagnosed by a specialist of the Japan Dementia Society.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Trail Making Test

Key secondary outcomes

Eichner's classification
occlusal force


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Group of LBD with chewing gum for 1 minuit

Interventions/Control_2

Group of LBD with rest for 1 minuit

Interventions/Control_3

Group of AD with chewing gum for 1 minuit

Interventions/Control_4

Group of AD with rest for 1 minuit

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

・Patients who have been diagnosed with dementia by a specific physician
・Patients with a diagnosis of LBD
・Patients with a diagnosis of AD
・MMSE score: 21-26

Key exclusion criteria

・Non-dementia patients
・Dementia patients with a diagnosis other than LBD or AD
・MMSE score: under 21
・Patients with extremely low masticatory function

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Katsuhiko
Middle name
Last name Kimoto

Organization

Kanagawa Dental University

Division name

Department of Fixed Prosthodontics

Zip code

2388580

Address

82 Inaoka, Yokosuka, Kanagawa, Japan

TEL

046(822)8884

Email

hoshi@kdu.ac.jp


Public contact

Name of contact person

1st name Noriyuki
Middle name
Last name Hoshi

Organization

Kanagawa Dental University

Division name

Department of Fixed Prosthodontics

Zip code

2388580

Address

82 Inaoka, Yokosuka, Kanagawa, Japan

TEL

046(822)8884

Homepage URL


Email

hoshi@kdu.ac.jp


Sponsor or person

Institute

Kanagawa Dental University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kanagawa Dental University Research Ethics Review Committee

Address

82 Inaoka, Yokosuka, Kanagawa 2388580, Japan

Tel

046(822)9690

Email

murakami@kdu.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

2022 Year 09 Month 02 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

Open public recruiting

Date of protocol fixation

2020 Year 04 Month 27 Day

Date of IRB

2020 Year 06 Month 10 Day

Anticipated trial start date

2020 Year 10 Month 01 Day

Last follow-up date

2024 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

2022 Year 09 Month 02 Day

Last modified on

2022 Year 09 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055643


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name