UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038298
Receipt number R000043654
Scientific Title The efficacy test of composite 19815 for oral cavity
Date of disclosure of the study information 2019/10/15
Last modified on 2019/10/15 17:04:50

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Basic information

Public title

Efficacy test for oral cavity

Acronym

Efficacy test for oral cavity

Scientific Title

The efficacy test of composite 19815 for oral cavity

Scientific Title:Acronym

Efficacy test for oral cavity

Region

Japan


Condition

Condition

healthy adults

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the efficacy of composite 19815 for oral cavity

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of the dental plaque quantity, collection of dental plaque and saliva, photograph of oral cavity, and questionnaire after consecutive 2 days use of 19815 following tooth cleaning. Collection of dental plaque, saliva and questionnaire after consecutive 3 days use of 19815.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

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

10

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days.

Interventions/Control_2

Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days.

Interventions/Control_3

Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days.

Interventions/Control_4

Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days.

Interventions/Control_5

Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days.

Interventions/Control_6

Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days.

Interventions/Control_7

Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days.

Interventions/Control_8

Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with placebo composite in 9 times per 3 days.

Interventions/Control_9

Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days.

Interventions/Control_10

Ingest with placebo composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control1 composite in 9 times per 3 days. After washout over 4 days, Ingest with 19815 composite in 9 times per 3 days. After washout over 4 days, Ingest with positive control2 composite in 9 times per 3 days.


Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

59 years-old >=

Gender

Male and Female

Key inclusion criteria

-Male or female of 20 to 59 years of age

Key exclusion criteria

-Subjects with systemic illness
-Subjects with a disease in the oral cavity and are consulting the medical institution
-Subjects undergoing orthodontic therapy
-Subjects with denture
-Subjects with an implant
-The pregnant and subjects who hope to get pregnant during the exam period
-Subjects who are taking prescription medicine (except for anti-hay fever)
-Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Yoshihiko
Middle name
Last name Minegishi

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

321-3497

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7817

Email

minegishi.yoshihiko@kao.com


Public contact

Name of contact person

1st name Hatsumi
Middle name
Last name Souno

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

321-3497

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7817

Homepage URL


Email

souno.hatsumi@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

+81-3-5630-7263

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

花王株式会社(栃木県)


Other administrative information

Date of disclosure of the study information

2019 Year 10 Month 15 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

2019 Year 08 Month 09 Day

Date of IRB

2019 Year 08 Month 09 Day

Anticipated trial start date

2019 Year 10 Month 15 Day

Last follow-up date

2019 Year 12 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

2019 Year 10 Month 15 Day

Last modified on

2019 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043654


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name