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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028808
Receipt No. R000032971
Scientific Title A Study on the dynamics of gingival blood flow
Date of disclosure of the study information 2017/09/01
Last modified on 2019/09/12

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Basic information
Public title A Study on the dynamics of gingival blood flow
Acronym A Study on the dynamics of gingival blood flow
Scientific Title A Study on the dynamics of gingival blood flow
Scientific Title:Acronym A Study on the dynamics of gingival blood flow
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of physiological stimuli and physical therapy to the dynamics of gingival blood flow
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the gingival blood flow before and after the physiological stimuli/single treatment with the physical therapy, and after the repeated treatment for 2,4 and 8 weeks with the physical therapy
Key secondary outcomes Probing pocket depth (PPD)
Gingival index (GI)
Bleeding on probing (BOP)
Dental plaque
PMA Index
Color of gingiva
Blood pressure
Heart rate
Electrocardiogram

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but 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
Interventions/Control_1 Apply the physical therapy for gingiva more than once a day for 8 weeks
Interventions/Control_2 Do not apply any physical therapy for gingiva for 8 weeks
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
69 years-old >=
Gender Male and Female
Key inclusion criteria Healthy males and females with healthy gingiva
Key exclusion criteria -Subjects who are under dentist's/doctor's treatment
-Subjects with serious wound in the oral cavity
-Subjects with acute inflammation of the gingiva
-Subjects with tooth mobility
-Severe periodontitis
-Hypertension
-Pregnancies
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yoshifumi
Middle name
Last name Niki
Organization Kao Corporation
Division name Personal Healthcare Products Research
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL +81-3-5630-9848
Email niki.yoshifumi@kao.co.jp

Public contact
Name of contact person
1st name Yuko
Middle name
Last name Ohsugi
Organization Kao Corporation
Division name Personal Healthcare Products Research
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL +81-3-5630-7486
Homepage URL
Email ohsugi.yuko@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Human Research Ethics Committee, Kao Corporation
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel +81-3-5630-9220
Email uesaka.toshio@kao.co.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 花王株式会社(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 01 Day

Related information
URL releasing protocol None
Publication of results Unpublished

Result
URL related to results and publications None
Number of participants that the trial has enrolled 60
Results
a
Results date posted
2019 Year 09 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
a
Participant flow
a
Adverse events
a
Outcome measures
a
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 07 Month 20 Day
Date of IRB
2017 Year 07 Month 20 Day
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 09 Month 12 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 24 Day
Last modified on
2019 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032971

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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