UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020898
Receipt number R000024110
Scientific Title Evaluation for the method of intervention regarding oral health improvement for people with disabilities at the service center
Date of disclosure of the study information 2016/02/05
Last modified on 2016/04/04 13:00:55

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Basic information

Public title

Evaluation for the method of intervention regarding oral health improvement for people with disabilities at the service center

Acronym

Evaluation for the method of intervention regarding oral health improvement for people with disabilities at the service center

Scientific Title

Evaluation for the method of intervention regarding oral health improvement for people with disabilities at the service center

Scientific Title:Acronym

Evaluation for the method of intervention regarding oral health improvement for people with disabilities at the service center

Region

Japan


Condition

Condition

oral diseases

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This aim of this study is to examine the way of intervention of dental hygienists to make disabled persons improve their oral health by themselves.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Before and after the intervation for the staffs, the oral condition of the users will be compared with the check seats.
1. The number of bacteria in the saliva and the tongue coating will be counted by using Bacterial counter.
2. The quantity of the tongue coating, the number of the remaining teeth and the functional teeth will be investigated.
3. The plaque and calculus will be analyzed with Simplified Oral Hygiene Index (OHI-S).
4. The oral moisture will be evaluated with the Moisture checker.
5. The halitosis (the concentration of VSCs) will be investigated with the Halitosis meter.

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Oral health education to all staff (about 1 hour; one time)

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

People with disabilities

Key exclusion criteria

none

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi ARAKAWA

Organization

Tokyo Medical and Dental University

Division name

Graduate School of Medical and Dental Sciences / Lifetime Oral Health Care Sciences

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan

TEL

03-5803-4968

Email

shinperi@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masayo YASUDA

Organization

Tokyo Medical and Dental University

Division name

Dental Hospital / Clinic for Oral Health Care

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan

TEL

03-5803-4970

Homepage URL


Email

yasuda.ocsh@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and 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


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



Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 05 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

Preinitiation

Date of protocol fixation

2016 Year 01 Month 14 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 02 Month 05 Day

Last modified on

2016 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024110


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name