UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026455
Receipt number R000030391
Scientific Title Efficacy test of the product combined a new detergent.
Date of disclosure of the study information 2017/03/08
Last modified on 2017/08/22 17:25:03

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Basic information

Public title

Efficacy test of the product combined a new detergent.

Acronym

Efficacy test of a new detergent.

Scientific Title

Efficacy test of the product combined a new detergent.

Scientific Title:Acronym

Efficacy test of a new detergent.

Region

Japan


Condition

Condition

Gingivitis, Periodontitis, Oral malodor

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of a new detergent for oral condition and microbial flora.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Oral condition and bacterial flora before and after using the product.

Key secondary outcomes

Oral bacterial flora
Probing pocket depth (PPD)
Gingival index (GI)
Bleeding on probing (BOP)
Dental 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

Prevention

Type of intervention

Other

Interventions/Control_1

Using a new detergent product for 3 months

Interventions/Control_2

Using a Placebo for 3 months

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

Over 40 years old males

Key exclusion criteria

1. Subjects who received treatment of oral disease in dental clinic
2. Subjects with serious wound in the oral cavity
3. Subjects with severe inflammation of the gingiva
4. Subjects with full denture
5. Subjects who have no intension use supplied products.
6. Subjects who was judged inappropriate by researcher

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yano Yoshitaka

Organization

Kao Corporation

Division name

R&D-Development Research-Personal Health Care Products Research

Zip code


Address

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

TEL

03-5630-9751

Email

yanou.yoshitaka@kao.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Teppei Tajikara

Organization

Kao Corporation

Division name

R&D-Development Research-Personal Health Care Products Research

Zip code


Address

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

TEL

03-5630-9750

Homepage URL


Email

tajikara.teppei@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


Address


Tel


Email



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

2017 Year 03 Month 08 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

Completed

Date of protocol fixation

2017 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 03 Month 08 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 03 Month 08 Day

Last modified on

2017 Year 08 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030391


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name