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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002713
Receipt No. R000003307
Scientific Title Randomized cross over trial on an effect of quercus salicina extract chewing gum on genuine halitosis.
Date of disclosure of the study information 2009/12/01
Last modified on 2010/11/06

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Basic information
Public title Randomized cross over trial on an effect of quercus salicina extract chewing gum on genuine halitosis.
Acronym Effect of quercus salicina extract gum on physiological halitosis.
Scientific Title Randomized cross over trial on an effect of quercus salicina extract chewing gum on genuine halitosis.
Scientific Title:Acronym Effect of quercus salicina extract gum on physiological halitosis.
Region
Japan

Condition
Condition genuine halitosis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study evaluates the short-term effect of quercus salicina extract chewing gum on genuine halitosis in a cross over trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes measurement of volatile sulfur compounds in breath
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 Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Quercus salicina extract chewing gum group: Subjects chew one piece of chewing gum (3g/1piece) for ten minutes.
Interventions/Control_2 Placebo gum group: Subjects chew one piece of chewing gum (3g/1piece) for ten minutes.
Interventions/Control_3
Interventions/Control_4
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
60 years-old >
Gender Male and Female
Key inclusion criteria Genuine halitosis
. Organoreptic score more than 2 and total volatile sulfur compounds more than 0.15 ppm
Key exclusion criteria Subjects without genuine halitosis
A history of systemic disease
Antibiotic treatment or periodontal treatment within the previous 3 months
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Muneo Tanaka
Organization Osaka University Dental Hospital
Division name Department of Preventive Dentistry
Zip code
Address 1-8, Yamadaoka, Suita, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Muneo Tanaka
Organization Osaka University Dental Hospital
Division name Department of Preventive Dentistry
Zip code
Address 1-8, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-2922
Homepage URL
Email

Sponsor
Institute Osaka University Dental Hospital Department of Preventive Dentistry
Institute
Department

Funding Source
Organization Taiyo corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 大阪大学歯学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2010 Year 02 Month 01 Day
Date of closure to data entry
2010 Year 05 Month 01 Day
Date trial data considered complete
2010 Year 05 Month 01 Day
Date analysis concluded
2010 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 11 Month 05 Day
Last modified on
2010 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003307

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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