UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034774
Receipt number R000039582
Scientific Title The effect of dentifrice component on blood flow promoting in gingiva
Date of disclosure of the study information 2018/11/10
Last modified on 2020/05/07 13:57:09

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Basic information

Public title

The effect of dentifrice component on blood flow promoting in gingiva

Acronym

The effect of dentifrice component on blood flow promoting in gingiva

Scientific Title

The effect of dentifrice component on blood flow promoting in gingiva

Scientific Title:Acronym

The effect of dentifrice component on blood flow promoting in gingiva

Region

Japan


Condition

Condition

periodontitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In the periodontal therapy, removal of plaque and calculus is the most important treatment. Since plaque deposits on the tooth surface in an short time, it is necessary to remove it by daily self-care by the patient himself/herself. Generally brushing is performed using a dentifrice, and recently toothpaste containing 1,2 tocoperol nicotinate (vitamin En: VEN) which has a blood flow promoting effect is commercially available.
In this study, a crossover test using VEN containing dentifrice and placebo dentifrice, which is already on the market, is carried out, and the gingival blood flow promoting action and its clinical effect are examined.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in the color of cervical gingiva
(before treatment, after using VEN containing dentifrice and placebo dentifrice)

Key secondary outcomes

1. gingival index (GI)
2. plaque index (PI)
3. amount of VEFG and PGE2 in gingival crecivular fluid
(befoe treatment, after using VEN containing dentifrice and placebo dentifrice)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Tooth brushing with dentifrice containing blood flow promoting component for 7days

Interventions/Control_2

Tooth brushing with placebo dentifrice for 7days

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

1. Patients of Periodontics in Dental Hospital of Tokyo Medical and Dental University
2. 20 years and over

Key exclusion criteria

1. Patients suffering from infectious diseases such as hepatitis B, hepatitis C and HIV

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Koji
Middle name
Last name Mizutani

Organization

Tokyo Medical and Dental University

Division name

Department of Peridonotology

Zip code

113-8510

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

0358035488

Email

mizuperi@tmd.ac.jp


Public contact

Name of contact person

1st name koji
Middle name
Last name Koji Mizutani

Organization

Tokyo Medical and Dental University

Division name

Department of Peridonotology

Zip code

113-8510

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

0358035488

Homepage URL


Email

mizuperi@tmd.ac.jp


Sponsor or person

Institute

Department of Periodontology, Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Sunstar Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Sunstar Inc.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Department of Periodontology, Tokyo Medical and Dental university

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

Tel

03-5803-0196

Email

mizuperi@tmd.ac.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

東京医科歯科大学歯学部附属病院


Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 10 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

Enrolling by invitation

Date of protocol fixation

2018 Year 12 Month 01 Day

Date of IRB

2019 Year 03 Month 18 Day

Anticipated trial start date

2019 Year 12 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 11 Month 05 Day

Last modified on

2020 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039582


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name