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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006356
Receipt No. R000007544
Scientific Title Study on the effects of periodontal treatment on metabolic control of type 2 diabetes
Date of disclosure of the study information 2011/09/20
Last modified on 2013/02/18

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Basic information
Public title Study on the effects of periodontal treatment on metabolic control of type 2 diabetes
Acronym The effects of periodontal treatment on diabetes
Scientific Title Study on the effects of periodontal treatment on metabolic control of type 2 diabetes
Scientific Title:Acronym The effects of periodontal treatment on diabetes
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To understand the effects of periodontal treatment on the changes of glycated hemoglobin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in Hemoglobin A1c
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria type 2 diabetes without insulin therapy
Key exclusion criteria acute illness
chronic fatigue disease
anti-inflammatory medication recipient
depression
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nishimura, Fusanori
Organization Hiroshima University Graduate School of Biomedical Sciences
Division name Department of Dental Science for Health Promotion
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553
TEL 082-257-5655
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nishimura, Fusanori
Organization Hiroshima University Graduate School of Biomedical Sciences
Division name Department of Dental Science for Health Promotion
Zip code
Address
TEL
Homepage URL
Email fusanori@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima Study
Institute
Department

Funding Source
Organization self funding
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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 Epidemiology-59 (2008)
Org. issuing International ID_1 Hiroshima University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Periodontal treatment resullted in improvement in hemoglobin A1c 
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 Completed
Date of protocol fixation
2008 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2012 Year 06 Month 30 Day
Date analysis concluded
2012 Year 07 Month 31 Day

Other
Other related information The effects of periodontal treatment on the changes of hemoglobin A1c

Management information
Registered date
2011 Year 09 Month 15 Day
Last modified on
2013 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007544

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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