UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028808
Receipt number 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 2020/06/15 17:14:26

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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 or person

Institute

Kao Corporation

Institute

Department

Personal name



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

Value
https://center6.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