Effect of Self Tooth Whitening for Tooth Color and Halitosis

Not Applicable

• Conditions: /A(healthy adults)

• Registration Number: JPRN-UMIN000028822
• Lead Sponsor: TES Holdings Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[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 Outcome Measures

Name	Time	Method
*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)