UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049704
Receipt number R000056616
Scientific Title Ingestion test of the oral composition
Date of disclosure of the study information 2022/12/09
Last modified on 2022/12/06 14:52:30

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Basic information

Public title

Efficacy test of the oral composition

Acronym

Efficacy test of the oral composition

Scientific Title

Ingestion test of the oral composition

Scientific Title:Acronym

Efficacy test of the oral composition

Region

Japan


Condition

Condition

Gingivitis

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy for oral condition of the oral composition T0210(code).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Gingival condition before and after 8wks application

Key secondary outcomes

Ratio of specific bacteria in plaque


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingest T0210 three times a day for 8wks.

Interventions/Control_2

Ingest placebo three times a day for 8wks.

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Male and female aged 20-65
2. Those who have gingival inflammation that falls under any of the following A, B, or C
A. When brushing your teeth, the gums may bleed.
B. Gingiva may swell
C. At dental offices and dental checkups, it has been pointed out that the gums are swollen and the periodontal pockets are deep.

Key exclusion criteria

(1) Those suffering from systemic diseases (diabetes, heart disease, kidney disease, liver disease, congenital heart disease, etc.)
(2) Those who are taking drugs to improve glucose metabolism and lipid metabolism, or antihypertensive drugs
(3) Those who plan to consume foods for specified health uses, foods with function claims, and dietary supplements (supplement foods such as capsules) that are considered to affect this study during the study period (which appeal to triglycerides, blood sugar, blood pressure, cholesterol, and body fat)
(4) Those who have obvious trauma in the oral cavity
(5) Those who are visiting a medical institution due to severe periodontal disease or oral disease
(6) Those who have been prescribed antibiotics at a dental clinic due to gingival swelling within one year
(7) Those who have had fever or respiratory symptoms in themselves or a family member living with them from one week before the measurement date, or those who have been in close contact with a person infected with the covid-19.
(8) Those who use mouthwash on a daily basis (e.g., isodine mouthwash, clean mouthwash, gargle fresh, etc.)
(9) Those who have collected 200 mL or more of blood (blood donation, etc.) within one month of the start of this study or 400 mL within three months.
(10) Those who have severe anemia in the most recent medical examination
(11) Those who have experienced side effects (feeling sick, dizziness, nausea, collapse, etc.) after blood collection
(12) Those who have been allergic to sugar alcohols such as xylitol and erythritol in the past
(13) Those who, for other reasons, are judged to be ineligible for the test by the dentist in charge of the trial or the director of the test and research.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Susumu
Middle name
Last name Nakatsu

Organization

Kao Corporation

Division name

Personal Health Care Products Research Lab.

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN

TEL

+81-3-5630-9747

Email

nakatsu.susumu@kao.com


Public contact

Name of contact person

1st name Teppei
Middle name
Last name Tajikara

Organization

Kao Corporation

Division name

Personal Health Care Products Research Lab.

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN

TEL

+81-3-5630-9747

Homepage URL


Email

tajikara.teppei@kao.com


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

+81-3-5630-9064

Email

morisaki.naoko@kao.com


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



Other administrative information

Date of disclosure of the study information

2022 Year 12 Month 09 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

Preinitiation

Date of protocol fixation

2022 Year 10 Month 13 Day

Date of IRB

2022 Year 10 Month 13 Day

Anticipated trial start date

2022 Year 12 Month 09 Day

Last follow-up date

2023 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 12 Month 06 Day

Last modified on

2022 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056616


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name