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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023832
Receipt No. 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

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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
Institute Lotte Co., Ltd.
Institute
Department

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
URL(English) https://upload.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


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