UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Crossover test for reducing oral malodor by the chewing gums containing Myrsine seguinii extracts
Title of the study (Brief title)	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	Ken Yaegaki
Organization	Nippon Dental University School of Life Dentistry at Tokyo
Division name	Department of Oral Health
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	Keishirou Yoshida
Organization	LOTTE CO., LTD.
Division name	Central Laboratory, Food Function Development Section
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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