UMIN-CTR Clinical Trial

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