UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023832
Receipt number R000027456
Scientific Title Crossover test for reducing oral malodor by the chewing gums containing Myrsine seguinii extracts
Date of disclosure of the study information 2016/08/31
Last modified on 2016/08/30 10:31:21

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Basic information

Public title

Crossover test for reducing oral malodor by the chewing gums containing Myrsine seguinii extracts

Acronym

Oral malodor reducing effect by Myrsine seguninii chewing gum

Scientific Title

Crossover test for reducing oral malodor by the chewing gums containing Myrsine seguinii extracts

Scientific Title:Acronym

Oral malodor reducing effect by Myrsine seguninii chewing gum

Region

Japan


Condition

Condition

Physiological halitosis

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We determine the reducing effects by the chewing gums containing Myrsine seguinii extracts on oral malodor

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The concentration of Volatile Sulfur Compounds (hydrogen sulfide and methyl mercaptan) in the oral air

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

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

High-dose extract-containing Chewing gum

Interventions/Control_2

Middle-dose extract-containing Chewing gum

Interventions/Control_3

Low-dose extract-containing Chewing gum

Interventions/Control_4

Control Chewing gum

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

A. Normally eating three times daily.
B. In the screening test, 1.5 ng or more than 1.5 ng of hydrogen sulfide in 10 mL mouth air by gas chromatography.
C. No dental treatment now and at least 20 natural teeth.
D. Without the habit to brush the tongue during toothbrushing (It was allowed who quitted the tongue brushing during the test period)
E. Received the sufficient explanation about the purpose and the content of the study, had the consent ability, volunteered to voluntarily participate in to fully understand, and agreed to the study participation in writing

Key exclusion criteria

1. Smokers
2. Suffering from diabetes mellitus, Chronic nephritis, stomach disorders, lung diseases, malignant tumors, hepatitis, taking medicines.
3. Utilizing mouthwash or anti-malodor products daily.
4. Currently participating or trying to participate in the studies of other medicines or foods.
5. At the screening test, being diagnosed with periodontitis or dental caries.
6. Wearing removable denture.
7. Taking antibiotics / antimicrobial within one month before the screening test.
8. With food allergies, lactose intolerance or feeling of unwellness by the dairy products.
9. Pregnant or with the intention of pregnancy or while breast-feeding during the test.
10. Judged to be inappropriate to the test by the chief researcher because of the other reasons than mentioned above.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken Yaegaki

Organization

Nippon Dental University School of Life Dentistry at Tokyo

Division name

Department of Oral Health

Zip code


Address

1-9-20 Fujimi, Chiyoda-ku, Tokyo

TEL

03-3261-8791

Email

Yaegaki-k@tky.ndu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keishirou Yoshida

Organization

LOTTE CO., LTD.

Division name

Central Laboratory, Food Function Development Section

Zip code


Address

3-1-1, Numakage, Minami-Ku, Saitama

TEL

048-837-0187

Homepage URL


Email

yoshida_keishirou@lotte.co.jp


Sponsor or person

Institute

Lotte Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Lotte Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

日本歯科大学生命歯学部(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 31 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

2015 Year 10 Month 30 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 31 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 04 Month 30 Day

Date trial data considered complete

2016 Year 04 Month 30 Day

Date analysis concluded

2016 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 08 Month 30 Day

Last modified on

2016 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027456


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name