UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006446
Receipt number R000007647
Scientific Title Effectiveness of oral care by ultrasonic toothbrushes for the moisture on oral mucosa among dependent elderly people -Randomized Controlled Trial-
Date of disclosure of the study information 2011/10/01
Last modified on 2014/04/03 18:46:01

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Basic information

Public title

Effectiveness of oral care by ultrasonic toothbrushes for the moisture on oral mucosa among dependent elderly people -Randomized Controlled Trial-

Acronym

Effectiveness of oral care by ultrasonic toothbrushes study ; ESUTS

Scientific Title

Effectiveness of oral care by ultrasonic toothbrushes for the moisture on oral mucosa among dependent elderly people -Randomized Controlled Trial-

Scientific Title:Acronym

Effectiveness of oral care by ultrasonic toothbrushes study ; ESUTS

Region

Japan


Condition

Condition

Dry mouth

Classification by specialty

Geriatrics Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to determine whether oral care by ultrasonic toothbrushes is effective for the moisture on oral mucosa among disabled elderly people

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Moisture of the oral mucosa

Key secondary outcomes

Oral Hygiene Status
Frequency of thirst
Mouth respiration
Clinical Diagnosis
Swallowing function
etc


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

We conduct the randomized controlled trial to examine effectiveness of the oral care for the oral mucosa using ultrasonic toothbrushes. Intervention is performed twice a week for four weeks.

Interventions/Control_2

In control group, we perform the conventional tooth brushing twice a week for four weeks.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1.The elderly who staying in nursing homes or hospitals
2.The elderly with difficulty for self-oral cleaning

Key exclusion criteria

1)Having oral cancer,
2)Received intraoral radiation therapy at any time in the past
3)Having salivary gland disease.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuaki Kakinoki

Organization

Kyushu Dental University

Division name

Division of Special Needs and Geriatric Dentistry

Zip code


Address

2-6-1, Manazuru Kokurakita-ku Kitakyusyu, 803-8580, Japan

TEL

093-285-3074

Email

kakinoki@kyu-dent.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mami Endoh

Organization

Kyushu Dental University

Division name

Division of Special Needs and Geriatric Dentistry

Zip code


Address

2-6-1, Manazuru Kokurakita-ku Kitakyusyu, 803-8580, Japan

TEL

093-285-3074

Homepage URL


Email

r09endo@fa.kyu-dent.ac.jp


Sponsor or person

Institute

Division of Special Needs and Geriatric Dentistry, Kyushu Dental College

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

特別養護老人ホーム好日苑(東京都)、介護老人保健施設ちあき(愛知県)、武久病院(山口県)、三野原病院(福岡県)など


Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 01 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

2011 Year 07 Month 29 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date

2012 Year 03 Month 01 Day

Date of closure to data entry

2012 Year 03 Month 01 Day

Date trial data considered complete

2012 Year 04 Month 01 Day

Date analysis concluded

2012 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 09 Month 29 Day

Last modified on

2014 Year 04 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007647


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name