UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042458 |
|---|---|
| Receipt number | 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 19:19:02 |
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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
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
ogahpre@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048469
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
