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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034774
Receipt No. R000039582
Official scientific title of the study The effect of dentifrice component on blood flow promoting in gingiva
Date of disclosure of the study information 2018/11/10
Last modified on 2018/11/05

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Basic information
Official scientific title of the study The effect of dentifrice component on blood flow promoting in gingiva
Title of the study (Brief title) 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 Koji Mizutani
Organization Tokyo Medical and Dental University
Division name Department of Peridonotology
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-0196
Email mizuperi@tmd.ac.jp

Public contact
Name of contact person Koji Mizutani
Organization Tokyo Medical and Dental University
Division name Department of Peridonotology
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-0196
Homepage URL
Email mizuperi@tmd.ac.jp

Sponsor
Institute Department of Periodontology, Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 01 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 05 Day
Last modified on
2018 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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