UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation for the method of intervention regarding oral health improvement for people with disabilities at the service center
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shinichi ARAKAWA
Organization	Tokyo Medical and Dental University
Division name	Graduate School of Medical and Dental Sciences / Lifetime Oral Health Care Sciences
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	Masayo YASUDA
Organization	Tokyo Medical and Dental University
Division name	Dental Hospital / Clinic for Oral Health Care
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
TEL	03-5803-4970
Homepage URL
Email	yasuda.ocsh@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 01 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000024110