UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of oral care instruction based on behavioral science approach to patient perioperative cardiovascular disease
Title of the study (Brief title)	Effectiveness of oral care instruction based on behavioral science approach to patient perioperative cardiovascular disease
Region	Japan

Condition
Condition	Cardiovascular diseases
Classification by specialty	Cardiovascular surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of oral hygiene instruction by six-step method on decrease in oral bacteria among patients with cardiovascular disease in perioperative period
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of oral bacteria
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	oral hygiene instruction by six-step method
Interventions/Control_2	general oral hygien instruction
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Inpatients with cardiovascular diseases for cardiovascular surgery Patients who receive professional oral hygiene care during perioperative period Patients who receive anesthetic management
Key exclusion criteria	Patients who had antibiotics Patients that examiners consider inappropriate
Target sample size	60

Research contact person
Name of lead principal investigator	Omori Chie
Organization	kagawa University Hospital
Division name	Department of Oral and Maxillofacial Surgery
Address	1750-1, Owaza,Ikenobe,Miki cho, Kita-gun ,761-0793,Japan
TEL	087-898-5111
Email	chie-o-612@med.kagawa-u.ac.jp

Public contact
Name of contact person	Omori Chie
Organization	Kagawa University Hospital
Division name	Department of Oral and Maxillofacial Surgery
Address	1750-1, Owaza,Ikenobe,Miki cho, Kita-gun ,761-0793,Japan
TEL	087-898-5111
Homepage URL
Email	chie-o-612@med.kagawa-u.ac.jp

Sponsor
Institute	Kagawa University Hospital
Institute
Department

Funding Source
Organization	Kagawa University Hospital
Organization
Division
Category of Funding Organization	Other
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	2019 Year 02 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2017 Year 07 Month 31 Day
Date of closure to data entry	2017 Year 08 Month 30 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 05 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 29 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034970