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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
