UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002713 |
|---|---|
| Receipt number | 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 16:33:09 |
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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
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
Sponsor or person
Institute
Osaka University Dental Hospital Department of Preventive Dentistry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003307
