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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004775
Receipt No. R000005686
Scientific Title The effect of periodontal care on lipid profiles in type 2 diabetic patients.
Date of disclosure of the study information 2010/12/22
Last modified on 2010/12/22

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Basic information
Public title The effect of periodontal care on lipid profiles in type 2 diabetic patients.
Acronym The effect of periodontal care on lipid profiles in type 2 diabetic patients.
Scientific Title The effect of periodontal care on lipid profiles in type 2 diabetic patients.
Scientific Title:Acronym The effect of periodontal care on lipid profiles in type 2 diabetic patients.
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effect of periodontal care on lipid metabolism via attenuation of persistent inflammation in type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes PCR(plaque control record), proinflammatory markers(hsCRP, TNFa), HbA1c,lipid profiles(TC, HDL-C, LDL-C, TG, lipoprotein fraction)
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 oral care group
Interventions/Control_2 control group
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
80 years-old >=
Gender Male and Female
Key inclusion criteria type 2 diabetic subjects, who were hospitalized at our hospital for diabetes
Key exclusion criteria patients in whom the number of existing teeth was less than 12.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuhito Tone
Organization National Hospital Organization, Okayama Medical Center
Division name Department of Diabetes and Metabolism
Zip code
Address 1711-1, Tamasu, Kita-ku, Okayama, 701-1192, Japan.
TEL +81-86-294-9911
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsuhito Tone
Organization National Hospital Organization, Okayama Medical Center
Division name Department of Diabetes and Metabolism
Zip code
Address 1711-1, Tamasu, Kita-ku, Okayama, 701-1192, Japan.
TEL +81-86-294-9911
Homepage URL
Email aitone@okayama3.hosp.go.jp

Sponsor
Institute National Hospital Organization, Okayama Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor None
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 国立病院機構 岡山医療センター(岡山県)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 22 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 Enrolling by invitation
Date of protocol fixation
2008 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 12 Month 22 Day
Last modified on
2010 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005686

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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