UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028822 |
|---|---|
| Receipt number | R000032709 |
| Scientific Title | Effect of Self Tooth Whitening for Tooth Color and Halitosis |
| Date of disclosure of the study information | 2017/08/25 |
| Last modified on | 2017/12/14 09:10:02 |
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Basic information
Public title
Effect of Self Tooth Whitening for Tooth Color and Halitosis
Acronym
Effect of Self Tooth Whitening for Tooth Color and Halitosis
Scientific Title
Effect of Self Tooth Whitening for Tooth Color and Halitosis
Scientific Title:Acronym
Effect of Self Tooth Whitening for Tooth Color and Halitosis
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines to evaluate effect of self tooth whitening for tooth color and halitosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Oral examination (evaluation of tooth color with a colorimeter, measuring volatile sulphur compounds with oral odor measuring instrument, caries-related bacteria test; Week 0, Week 2, Week 4)
Key secondary outcomes
*Secondary outcomes
[1]Questionnaire of physical feeling (Week 0, Week 2, Week 4)
[2]Dental photography (Week 0, Week 2, Week 4)
*Safety index
[1]Dentist's questions (Week 0, Week 2, Week 4)
[2]Subject's diary(From the first day of ingestion of a test material to the last day of the test)
*Other index
[1]Dental inspection (Week 0)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Conducting self tooth whitening at participant's home (4 times for 2 weeks).
Interventions/Control_2
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1]Japanese males and females aged 30-59 years.
[2]Individuals who are healthy and are not suffered from a chronic malady including oral diseases.
[3]Individuals whose teeth stain and breath is bad.
[4]Individuals who drink coffee over 5 days a week.
[5]Individuals whose written informed consent has been obtained.
[6]Individuals who can come to the designated venue for this study and be inspected.
[7]Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1]Individuals using medical products.
[2]Individuals who are under dental treatment (ex. treatment for tooth decay, periodontal disease, and orthodontics).
[3]Individuals using artificial teeth and dental implant (except upper right and left #6, #7, and #8 and lower right and left #6, #7, and #8).
[4]Individuals who have temporomandibular joint disorder.
[5]Individuals who are sensitive to metal, foods, and latex.
[6]Individuals who have photosensitivity.
[7]Individuals who have a habit to use mouthwash.
[8]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[9]Individuals who are a patient or have a history of endocrine disease (when individuals have a history of endocrine disease, the principal shall decide whether he or she can participate with the study).
[10]Individuals with serious anemia.
[11]Individuals who are, are possibly or are lactating, or plan to get pregnant during the test period.
[12]Individuals who are dependening on alcohol or have other mental diseases.
[13]Individuals who are smoker.
[14]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[15]Individuals who participated in other clinical studies in the past 3 months.
[16]Individuals judged inappropriate for the study by the principal.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Nagaike |
Organization
Akamonmae Dental Clinic
Division name
Head
Zip code
Address
2F Ohara Bulding 5-24-6 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL
+81-3-3812-3132
info@tes-h.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoma Shimizu |
Organization
TES Holdings Co., Ltd
Division name
Administrative Department of Clinical Trials
Zip code
Address
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Aquafree Investment Co., Ltd
Organization
Division
Category of Funding Organization
Profit 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
| 2017 | Year | 08 | Month | 25 | 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
| 2017 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 25 | Day |
Last modified on
| 2017 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032709
