UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of salivary test on medical treatment for behaviors of diabetic patients
Title of the study (Brief title)	Effect of salivary test on medical treatment for behaviors of diabetic patients
Region	Japan

Condition
Condition	Diabetes mellitus, Periodontal disease
Classification by specialty	Endocrinology and Metabolism Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess change of diabetes patient's behavior with salivary test and dental instruction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of treatment behavior
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Salivary test
Interventions/Control_2	No salivary test
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Uncontrolled diabetes (HbA1c >=7.4%), No dental treatment for 1 year and Periodontal Risk Score >=0.25.
Key exclusion criteria	None
Target sample size	80

Research contact person
Name of lead principal investigator	Nobuichi Kuribayashi
Organization	Misaki internal medicine clinic
Division name	Internal Medicine
Address	6-44-9, Futawahigashi, Funabashi, Chiba, Japan
TEL	047-440-2222
Email	misakin@bh.wakwak.com

Public contact
Name of contact person	Akiko Kudo
Organization	Misaki internal medicine clinic
Division name	Internal Medicine
Address	6-44-9, Futawahigashi, Funabashi, Chiba, Japan
TEL	047-440-2222
Homepage URL
Email	misakin@bh.wakwak.com

Sponsor
Institute	Misaki internal medicine clinic
Institute
Department

Funding Source
Organization	None
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	2018 Year 09 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 11 Month 18 Day
Anticipated trial start date	2017 Year 12 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	2018 Year 08 Month 13 Day
Last modified on	2018 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038306