UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033737 |
|---|---|
| Receipt number | R000038306 |
| Scientific Title | Effect of salivary test on medical treatment for behaviors of diabetic patients |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2018/08/10 18:53:01 |
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Basic information
Public title
Effect of salivary test on medical treatment for behaviors of diabetic patients
Acronym
Effect of salivary test on medical treatment for behaviors of diabetic patients
Scientific Title
Effect of salivary test on medical treatment for behaviors of diabetic patients
Scientific Title:Acronym
Effect of salivary test on medical treatment for behaviors of diabetic patients
Region
| Japan |
Condition
Condition
Diabetes mellitus, Periodontal disease
Classification by specialty
| Endocrinology and Metabolism | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess change of diabetes patient's behavior with salivary test and dental instruction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of treatment behavior
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Salivary test
Interventions/Control_2
No salivary test
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Uncontrolled diabetes (HbA1c >=7.4%),
No dental treatment for 1 year and
Periodontal Risk Score >=0.25.
Key exclusion criteria
None
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuichi Kuribayashi |
Organization
Misaki internal medicine clinic
Division name
Internal Medicine
Zip code
Address
6-44-9, Futawahigashi, Funabashi, Chiba, Japan
TEL
047-440-2222
misakin@bh.wakwak.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Kudo |
Organization
Misaki internal medicine clinic
Division name
Internal Medicine
Zip code
Address
6-44-9, Futawahigashi, Funabashi, Chiba, Japan
TEL
047-440-2222
Homepage URL
misakin@bh.wakwak.com
Sponsor or person
Institute
Misaki internal medicine clinic
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
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
| 2018 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | 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
| 2018 | Year | 08 | Month | 13 | Day |
Last modified on
| 2018 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038306
