UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028822
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032709

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.