UMIN-CTR Clinical Trial

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	Published

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	2020 Year 06 Month 15 Day

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