UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on the oral environment in healthy subjects

Acronym

Effects of consumption of the test food on the oral environment in healthy subjects

Scientific Title

Effects of consumption of the test food on the oral environment in healthy subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on the oral environment in healthy subjects

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effect of consumption of the test food on the oral environment in healthy Japanese subjects

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measurement value of halitosis {brilliant breath (B/B) value in B/B checker}

Key secondary outcomes

1. Subjective symptom measured by visual analogue scale (an original questionnaire)

2. The volume of saliva

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Two weeks
Test food: Lactic acid bacteria and yeast-chewable tablet (yogurt flavor)
Administration: Take one tablet twice per day within 3-5 minutes (as long as possible) without chewing right after each toothbrushing in the morning and evening

*If you forget to lick the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_2

Duration: Two weeks
Test food: Placebo chewable tablet
Administration: Take one tablet twice per day within 3-5 minutes (as long as possible) without chewing right after each toothbrushing in the morning and evening

*If you forget to lick the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy subjects

5. Subjects who are concerned about their halitosis

6. Subjects who are concerned about their oral sticky

7. Subjects who are concerned about their oral dryness

8. Subjects whose measurement value of halitosis is relatively high

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily

5. Subjects who are currently taking medications (including herbal medicines) and supplements

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, lactation, or planning to become pregnant during this trial

8. Subjects who suffer from COVID-19

9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

10. Subjects who are judged as ineligible to participate in this study by the physician

11. Subjects who use artificial tooth, post crowns, dentures, implants or bridges

12. Subjects who regularly use gargle medicine or mouthwash

13. Subjects who have a medical history or current history of Sjogren's syndrome, or who are suspected it

14. Subjects who have diseases associated with salivary gland such as dry mouse and salivary stone disease

15. Subjects who are undergoing medical treatment for periodontosis or dental caries

16. Subjects who are dental treatment or have dental diseases

17. Subjects who are smokers, or started smoking cessation within one year before the agreement to participate in this trial

Target sample size

30

Name of lead principal investigator

1st name	Masahiko
Middle name
Last name	Horiuchi

Organization

Medical Corporation Yuseikai, Horiuchi Dental Clinic

Division name

Director

Zip code

141-0022

Address

2F AM Bldg., 2-3-3, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-3449-1033

Email

dr_horiuchi@orthomedico.jp

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

Maikon no kohara Corporation.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Medical Corporation Yuseikai, Horiuchi Dental Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

医療法人社団優正会 堀内歯科医院 (東京都)
Medical Corporation Yuseikai, Horiuchi Dental Clinic (Tokyo, Japan)

Date of disclosure of the study information

2022

Year

08

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

34

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

Recruitment status

No longer recruiting

Date of protocol fixation

2022

Year

07

Month

20

Day

Date of IRB

2022

Year

07

Month

20

Day

Anticipated trial start date

2022

Year

08

Month

05

Day

Last follow-up date

2022

Year

10

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

08

Month

05

Day

Last modified on

2022

Year

09

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055379