UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056501 |
|---|---|
| Receipt number | R000064567 |
| Scientific Title | Whitening efficacy and tooth sensitivity of at-home whitening with 6% hydrogen peroxide: A randomized controlled clinical trial |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2024/12/19 15:08:39 |
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Basic information
Public title
A clinical study evaluating the whitening efficacy and tooth hypersensitivity of newly develop at-home whitening system
Acronym
Clinical study on at-home whitening
Scientific Title
Whitening efficacy and tooth sensitivity of at-home whitening with 6% hydrogen peroxide: A randomized controlled clinical trial
Scientific Title:Acronym
Clinical study on at-home whitening with 6% hydrogen peroxide
Region
| Japan |
Condition
Condition
vital discolored teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this clinical study was to understand the bleaching effect of the new home whitening "Tion Home With" and the occurrence of intraoperative and postoperative hypersensitivity.
Basic objectives2
Others
Basic objectives -Others
comparison with previous version of at-home whitening product
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
whitening efficacy (after 24 H), occurrence of hypersensitivity (during treatment, after 24 h),
Key secondary outcomes
color stability (6-month, 1-year, 2-year)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
at-home whitening with 6% hydrogen peroxide, 10 days, 1h
Interventions/Control_2
at-home whitening with 10% carbamide peroxide, 14 days, 2 h
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria for this study were the possession of six vital front teeth, first premolars, and second premolars in the upper jaw without caries lesions, restorations, large cracks, or tooth sensitivity. In addition, the patients had to be at least 18 years old with a maxillary anterior shade between A2 and A3.5 (VITA classical A1-D4 shade guide).
Key exclusion criteria
The exclusion criteria were allergy to hydrogen peroxide, periodontal disease, poor oral hygiene, ongoing treatment for a serious, systemic, and chronic disease, pregnancy or breastfeeding, previous whitening treatment, severe tetracycline-induced discoloration or fluorosis, and any other conditions deemed unsuitable by the supervising dentist.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Takamizawa |
Organization
Nihon University School of Dentistry
Division name
Operative Dentistry
Zip code
1018310
Address
kandasurugadai 1-8-13, Chiyoda-ku, Tokyo
TEL
0332198141
takamizawa.toshiki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | Takamizawa |
| Last name | Takamizawa |
Organization
Nihon University School of Dentistry
Division name
Department of Operative Dentistry
Zip code
1018310
Address
kandasurugadai 1-8-13, Chiyoda-ku, Tokyo
TEL
0332198141
Homepage URL
takamizawa.toshiki@nihon-u.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Toshiki Takamizawa
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Nihon University School of Dentistry
Address
Kandasurugadai1-8-13, Chiyoda-ku, Tokyo
Tel
0332198141
takamizawa.toshiki@nihon-u.ac.jp
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
日本大学歯学部付属歯科病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
No significant difference was observed in the color difference after whitening between the "With" group and the "Tion" group. In addition, in terms of L*, a*, and b*, L* tended to increase, while a* and b* tended to decrease in all groups. The new home whitening material "With," which contains 6% hydrogen peroxide, was able to achieve the same bleaching effect in a shorter time than the previous home whitening material that used 10% urea peroxide.
Results date posted
| 2024 | Year | 12 | Month | 19 | Day |
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
Main results already published
Date of protocol fixation
| 2024 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064567
