UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013865
Receipt number R000016175
Scientific Title A study of the relationship among the oral statements, the oral functions, the life habits and the bone density in the persons with disabilities.
Date of disclosure of the study information 2014/05/07
Last modified on 2018/06/07 10:03:31

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Basic information

Public title

A study of the relationship among the oral statements, the oral functions, the life habits and the bone density in the persons with disabilities.

Acronym

A study of the relationship among the oral statements and the bone density in the persons with disabilities

Scientific Title

A study of the relationship among the oral statements, the oral functions, the life habits and the bone density in the persons with disabilities.

Scientific Title:Acronym

A study of the relationship among the oral statements and the bone density in the persons with disabilities

Region

Japan


Condition

Condition

oral disease, osteoporosis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the relationship between bone density and oral symptoms as systemic disorders in patients examined at the special needs dental center.Disabled individuals,who are at risk of decreased bone density,will be targeted as subjects and an intervention study regarding strategies for maintaining and improving bone density will be conducted.

Basic objectives2

Others

Basic objectives -Others

To conduct an investigation regarding bone density in patients examined at the special needs dental center. Also, to investigate the relationship between bone density and disabled subjects oral symptoms, physique, exercise, lifestyle habits including dietary habits, regular medication and food consumption/swallowing function.
To conduct a cohort study to maintain and improve bone density targeting individuals with decreased bone density or at risk of bone density due to exhibiting various factors and involving intervention including masticatory function improvement with dental treatment and oral care, eating and swallowing rehabilitation and dietary advice.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

bone density

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

Uncontrolled

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom Other

Interventions/Control_1

Of the patients from whom data is gathered, this study will target those with decreased bone density or considered to be at risk for decreased bone density due to the presence of certain factors. Intervention will then be conducted involving dental treatment, oral care, eating and swallowing rehabilitation, lifestyle advice and nutritional advice with the aim of maintaining and improving bone density. Bone density measurement will also be conducted regularly.

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

50 years-old >=

Gender

Male and Female

Key inclusion criteria

A person who is an adult. A person who has physical disabilities or intellectual disabilities.

Key exclusion criteria

A patient who are treated by drugs for treatment of osteoporosis.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takayuki Mori

Organization

Okayama university hospital

Division name

The Center of The Special Needs Dentistry

Zip code


Address

Shikata-cho 2-5-1, Kita-ku Okayama city

TEL

(086)235-6817

Email

moritaka@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takayuki Mori

Organization

Okayama university hospital

Division name

The Center of The Special Needs Dentistry

Zip code


Address

Shikata-cho 2-5-1, Kita-ku Okayama city

TEL

(086)235-6817

Homepage URL


Email

moritaka@md.okayama-u.ac.jp


Sponsor or person

Institute

The Center of The Special Needs Dentistry

Institute

Department

Personal name



Funding Source

Organization

JSPS

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



Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 07 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

2013 Year 09 Month 09 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 07 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

2014 Year 05 Month 01 Day

Last modified on

2018 Year 06 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016175


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name