UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010273 |
|---|---|
| Receipt number | R000011771 |
| Scientific Title | Improvement effect of oral environment and oral malodor by mouth cleaning with the gel containing hinokitiol |
| Date of disclosure of the study information | 2013/03/20 |
| Last modified on | 2013/03/19 10:07:05 |
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Basic information
Public title
Improvement effect of oral environment and oral malodor by mouth cleaning with the gel containing hinokitiol
Acronym
Improvement effect of hinokitiol on oral malodor
Scientific Title
Improvement effect of oral environment and oral malodor by mouth cleaning with the gel containing hinokitiol
Scientific Title:Acronym
Improvement effect of hinokitiol on oral malodor
Region
| Japan |
Condition
Condition
oral malodor
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to clarify the improvement effect of mouth cleaning by the gel containing hinokitiol (Rifrecare H) on oral environment and oral malodor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
organoleptic test, concentration of volatile sulfur compound, bleeding on probing, average of probing pocket depth, plaque index, tongue coating score
Key secondary outcomes
number of periodontopathic bacteria
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
mouth cleaning with gel containing hinokitiol
Interventions/Control_2
mouth cleaning with gel which does not combine hinokitiol
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
genuine halitosis
Key exclusion criteria
currently visiting a dentist for treatment, acute symptoms requiring immediate oral cavity treatment, antibiotic use within the last month, daily smoking habit, no systemic illness
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nao Taniguchi |
Organization
Fukuoka Dental College
Division name
Department of General Dentistry
Zip code
Address
2-15-1, Tamura Sawara-ku Fukuoka 814-0193, Japan
TEL
81-92-801-0411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Fukuoka Dental COllege
Division name
Department of General Dentistry
Zip code
Address
TEL
81-92-801-0411
Homepage URL
Sponsor or person
Institute
Department of General Dentistry, Fukuoka Dental College
Institute
Department
Personal name
Funding Source
Organization
a Grant-in-Aid for Young Scientists and for Scientific Research, a Grant-in-Aid for Advanced Science Research from the Ministry of Education, Culture, Sports, Science, and Technology, Japan.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2011 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 19 | Day |
Last modified on
| 2013 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011771
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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