UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of relation of the periodontal disease of the diabetics and diabetes conditions and complications
Title of the study (Brief title)	Analysis of complications and periodontal disease of the diabetics
Region	Japan

Condition
Condition	periodontal disease diabetes
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	evaluation of relation between the illness
Basic objectives2	Others
Basic objectives -Others	Effect of the periodontal disease treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Condition of periodontal disease connected with the condition of a patient of diabetes
Key secondary outcomes	Going to hospital frequency to the dental clinic

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Periodontal disease treatment
Interventions/Control_2	There is no periodontal disease treatment
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Diabetic
Key exclusion criteria	Person whom it is hard to stop bleeding
Target sample size	500

Research contact person
Name of lead principal investigator	Masato Minabe
Organization	Kanagawa Dental University
Division name	periodontology
Address	82 Inaoka-Cho, Yokosuka, Kanagawa, Japan
TEL	046-822-9581
Email	minabe@kdu.ac.jp

Public contact
Name of contact person	Masato Minabe
Organization	Kanagawa Dental University
Division name	periodontology
Address	82 Inaoka-Cho, Yokosuka, Kanagawa, Japan
TEL	046-822-9531
Homepage URL
Email	minabe@kdu.ac.jp

Sponsor
Institute	Kanagawa Dental University, Department of periodontology
Institute
Department

Funding Source
Organization	Kanagawa Dental University, Department of periodontology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 29 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 01 Month 27 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 29 Day
Last modified on	2018 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028332