N/A(healthy adults)
Conditions
Interventions
Conducting self tooth whitening at participant'
s home (4 times for 2 weeks).
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [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) | — |
Secondary
| Measure | Time frame |
|---|---|
| *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) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd Administrative Department of Clinical Trials
Outcome results
None listed