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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042458
Receipt No. R000048469
Scientific Title Randomised Control Trial for antimicrobial periodontal treatment for risk of stroke among diabetics
Date of disclosure of the study information 2020/11/15
Last modified on 2020/11/15

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Basic information
Public title Randomised Control Trial for antimicrobial periodontal treatment for risk of stroke among diabetics
Acronym Randomised Control Trial for antimicrobial periodontal treatment for risk of stroke
Scientific Title Randomised Control Trial for antimicrobial periodontal treatment for risk of stroke among diabetics
Scientific Title:Acronym Randomised Control Trial for antimicrobial periodontal treatment for risk of stroke
Region
Japan

Condition
Condition Diabetics, Stroke, Periodontal disease
Classification by specialty
Medicine in general Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the effects of antimicrobial periodontal treatment for the risk of stroke among diabetics based on the interaction of adipocytokines
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effects of antimicrobial periodontal treatment will be assessed by changes of the LOX-index, in the week of 12 and 24
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Periodontal treatment will be given at the baseline followed in the week of 2, 4 and 6.
For the test group, PERIOFEEL Dental Ointment 2% will be given to the periodontal pocket depth in which 4 mm or more.
Interventions/Control_2 For the control group, only periodontal treatment will be given at the baseline followed in the week of 2, 4 and 6.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects who have HbA1c 6.0% or more. Treatment for diabetics has not been changed in the previous two month.
As oral health criterial, subjects should have 10 or more present teeth and 4 or more among them have periodontal pocket depth in which 4 mm or more.
Key exclusion criteria Subjects who have stroke and are smokers.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Ogawa
Organization Graduate school of medical and dental sciences, Niigata University.
Division name Faculty of dentistry, Division of preventive dentistry
Zip code 9518514
Address 2-5274, Gakkocho-dori, Chuo-ku, Niigata 9518514, JAPAN
TEL 0252272857
Email ogahpre@dent.niigata-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Ogawa
Organization Graduate School of Medical and Dental Sciences, Niigata University
Division name Faculty of Dentistry, Division of Preventive Dentistry
Zip code 9518514
Address 2-5274, Gakkocho-dori, Chuo-ku, Niigata 9518514, JAPAN
TEL 0252272857
Homepage URL
Email ogahpre@dent.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Niigata University
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Graduate School of Medical and Dental Sciences, Niigata University
Address 2-5274, Gakkocho-dori, Chuo-ku, Niigata 9518514, JAPAN
Tel 0252272857
Email ogahpre@dent.niigata-u.ac.jp

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 新潟大学病院(新潟県)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 15 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
2020 Year 10 Month 01 Day
Date of IRB
2020 Year 08 Month 19 Day
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 15 Day
Last modified on
2020 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048469

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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