UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044864
Receipt number R000051244
Scientific Title Efficacy verification of a halitosis-preventive mouthwash on oral malodorous reduction
Date of disclosure of the study information 2021/07/14
Last modified on 2021/10/25 12:03:41

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Basic information

Public title

Efficacy verification of a halitosis-preventive mouthwash on oral malodorous reduction

Acronym

Efficacy verification of a halitosis-preventive mouthwash on oral malodorous reduction

Scientific Title

Efficacy verification of a halitosis-preventive mouthwash on oral malodorous reduction

Scientific Title:Acronym

Efficacy verification of a halitosis-preventive mouthwash on oral malodorous reduction

Region

Japan


Condition

Condition

Healthy male/female adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To validate the efficacy in oral malodorous reduction by applying a specified single dose of a halitosis-preventive mouthwash to the subjects who are aware of bad breath.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Concentration of hydrogen sulfide

Key secondary outcomes

1. The number of bacteria in saliva
2. Autoinducer-2 activity
3. Concentration of methyl mercaptan
4. Concentration of dimethyl sulfide


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

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Mouthwash using the test liquid (10 mL) for 20 sec, without rinsing.

Interventions/Control_2

Mouthwash using the placebo liquid (10 mL) for 20 sec, without rinsing.

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) Healthy males and females ranging in age from 20 to 64, at the time of informed consent.
(2) Subjects being applicable to at least one of the following criteria:
Subjects with self-recognition of bad breath
Subjects who have been pointed out their bad breath
Subjects who are aware of dry mouth
(3) Subjects with not less than 112 ppb of hydrogen-sulfide concentration in their breath.
(4) Subjects who have received enough explanation about this study and were able to understand that, and to give written informed consent.

Key exclusion criteria

(1) Subjects who are continuously taking medicines that may affect the test results, except applying a nasal spray and eye drops.
(2) Subjects who have any spots with not less than 7 mm of probing pocket depth.
(3) Subjects who are undergoing dental treatment for tooth decay, gingivitis, etc., or ones having tooth decay.
(4) Subjects equipped with partial/full dentures.
(5) Subjects being in the process of straightening their teeth.
(6) Subjects who have any tooth defecting, or coming off.
(7) Subjects having a severe medical history of dry mouth symptom, Sjogren's syndrome, or systemic illness.
(8) Subjects who have previous and/or current medical history of serious diseases (e.g., heart, liver, kidney, digestive organ).
(9) Females who are pregnant, lactating, or possibly pregnant.
(10) Subjects who are taking medicine, foods with functional claims, health foods, and oral care products (mouthwash, etc.) that may affect the improvement of oral function.
(11) Subjects with an extremely irregular dietary habits or lifestyle (e.g. alternative work schedule, graveyard shift).
(12) Subjects who take excessive alcohol.
(13) Subjects who are allergic to drugs or foods.
(14) Subjects who are participating or have been participated to the other clinical tests with some kind of medicine/food within the last 4 weeks before this trial, or planning to join those after giving informed consent.
(15) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinion.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Mie
Middle name
Last name Kaneko

Organization

Chiyoda Oralhealth Care Clinic

Division name

Director

Zip code

101-0061

Address

3F Suidobashi Nishiguchi Kaikan, 2-20-7 Kanda-Misaki-Cho, Chiyoda-ku, Tokyo, Japan

TEL

03-3288-8801

Email

cpcc-contact@cpcc.co.jp


Public contact

Name of contact person

1st name Mitsuhiro
Middle name
Last name Fujimoto

Organization

CPCC Company Limited

Division name

Clinical Planning Department

Zip code

101-0047

Address

4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo, Japan

TEL

03-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

CPCC Company Limited

Institute

Department

Personal name



Funding Source

Organization

KOBAYASHI Pharmaceutical Co., Ltd.

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

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan

Tel

03-5297-5548

Email

IRB@cpcc.co.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

チヨダオーラルヘルスケアクリニック
Chiyoda Oralhealth Care Clinic


Other administrative information

Date of disclosure of the study information

2021 Year 07 Month 14 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

2021 Year 06 Month 21 Day

Date of IRB

2021 Year 06 Month 18 Day

Anticipated trial start date

2021 Year 07 Month 19 Day

Last follow-up date

2021 Year 09 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 07 Month 14 Day

Last modified on

2021 Year 10 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051244


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name