UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021395
Receipt number R000024669
Scientific Title Study on drawing out of oral function improvement program to the need of nursing care
Date of disclosure of the study information 2016/03/10
Last modified on 2019/03/06 09:29:34

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Basic information

Public title

Study on drawing out of oral function improvement program to the need of nursing care

Acronym

Oral function improvement program to the need of nursing care

Scientific Title

Study on drawing out of oral function improvement program to the need of nursing care

Scientific Title:Acronym

Oral function improvement program to the need of nursing care

Region

Japan


Condition

Condition

Need of nursing care

Classification by specialty

Geriatrics Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study investigates effects on improvement of oral health and dietary situation by performing a professional oral care and oral function improvement training to nursing care elderly.
And, to find out change on awareness of sutaffs about oral health care.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Amount of saliva is evaluated from before making the oral care and oral function improvement training until after 6 months

Key secondary outcomes

Oral malodor, the degree of opening, evaluation oral hygiene status, nutrition status, such as systemic conditions, from prior to performing the oral care and oral function improvement training until after 6 months


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

Oral care and oral function improvement training twice a week, do three months, the evaluation is carried out for the baseline, three months, and
six months later.

Interventions/Control_2

The evaluation is carried out for the baseline, three months, and
six months later. Three months after, oral care and oral function improvement training twice a week, do three months.

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

65 years-old <=

Age-upper limit

110 years-old >=

Gender

Male and Female

Key inclusion criteria

Elderly at a nursing home

Key exclusion criteria

serious

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinada Kayoko

Organization

Tokyo Medical and Dental University,
graduate school

Division name

preventive oral health care science

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-4096

Email

shinada.ohp@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinada Kayoko

Organization

Tokyo Medical and Dental University,

Division name

preventive oral health care science

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-4096

Homepage URL


Email

shinada.ohp@tmd.ac.jp


Sponsor or person

Institute

Preventive oral health care science, Tokyo Medical and Dental University, graduate school

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental 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


Address


Tel


Email



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

東京医科歯科大学歯学部口腔保健学科研究室(東京都)、中野友愛ホーム(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 10 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


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

Main results already published

Date of protocol fixation

2016 Year 03 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 03 Month 08 Day

Last modified on

2019 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024669


Research Plan
Registered date File name
2016/09/07 2_実施計画書_倫理審査用実施計画書改訂5.30.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2016/09/07 10_施設職員アンケート.docx