UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the relationship among the oral statements, the oral functions, the life habits and the bone density in the persons with disabilities.
Title of the study (Brief title)	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	Takayuki Mori
Organization	Okayama university hospital
Division name	The Center of The Special Needs Dentistry
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	Takayuki Mori
Organization	Okayama university hospital
Division name	The Center of The Special Needs Dentistry
Address	Shikata-cho 2-5-1, Kita-ku Okayama city
TEL	(086)235-6817
Homepage URL
Email	moritaka@md.okayama-u.ac.jp

Sponsor
Institute	The Center of The Special Needs Dentistry
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2013 Year 09 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016175