UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031047 |
|---|---|
| Receipt number | R000034970 |
| Scientific Title | Effectiveness of oral care instruction based on behavioral science approach to patient perioperative cardiovascular disease |
| Date of disclosure of the study information | 2019/02/14 |
| Last modified on | 2019/03/08 09:01:04 |
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Basic information
Public title
Effectiveness of oral care instruction based on behavioral science approach to patient perioperative cardiovascular disease
Acronym
Effectiveness of oral care instruction based on behavioral science approach to patient perioperative cardiovascular disease
Scientific Title
Effectiveness of oral care instruction based on behavioral science approach to patient perioperative cardiovascular disease
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Omori Chie |
Organization
kagawa University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
1750-1, Owaza,Ikenobe,Miki cho, Kita-gun ,761-0793,Japan
TEL
087-898-5111
chie-o-612@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Omori Chie |
Organization
Kagawa University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
1750-1, Owaza,Ikenobe,Miki cho, Kita-gun ,761-0793,Japan
TEL
087-898-5111
Homepage URL
chie-o-612@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034970
