UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Self Tooth Whitening for Tooth Color and Halitosis
Title of the study (Brief title)	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	Yasuo Nagaike
Organization	Akamonmae Dental Clinic
Division name	Head
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	Ryoma Shimizu
Organization	TES Holdings Co., Ltd
Division name	Administrative Department of Clinical Trials
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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