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
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
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
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
