UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050164 |
|---|---|
| Receipt number | R000057136 |
| Scientific Title | A clinical investigation of whitening efficacy and tooth sensitivity in a combined in-office and at-home whitening protocol |
| Date of disclosure of the study information | 2023/02/10 |
| Last modified on | 2023/01/27 15:41:13 |
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Basic information
Public title
Influence of the dual whitening on the whitening efficacy and tooth sensitivity
Acronym
Study on dual whitening
Scientific Title
A clinical investigation of whitening efficacy and tooth sensitivity in a combined in-office and at-home whitening protocol
Scientific Title:Acronym
Clinical investigation of combined whitening
Region
| Japan |
Condition
Condition
Vital discolored tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the whitening efficacy and the prevalence of tooth sensitivity in dual whitening when prefilled at-home whitening trays were used at different frequencies between in-office whitening treatments.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
The changes in tooth color were evaluated using a dental spectrophotometer before and after in-office whitening. A visual analog scale (VAS) was used to express the pain intensity when participants felt tooth sensitivity during and up to 24 h after whitening.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All study participants gave their informed consent to take part in this study. 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 (Feinman classification 3 and 4) or fluorosis (Dean's index 3-5), and any other conditions deemed unsuitable by the supervising dentist.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | masashi |
| Middle name | |
| Last name | miyazaki |
Organization
Nihon University School of Dentistry
Division name
Department of Operative Dentistry
Zip code
101-8310
Address
1-8-13 Kandasurugadai Chiyoda-ku, Tokyo
TEL
0332198141
miyazaki.masashi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Takamizawa |
Organization
Nihon University School of Dentistry
Division name
Department of Operative Dentistry
Zip code
101-8310
Address
1-8-13 Kandasurugadai Chiyoda-ku, Tokyo
TEL
0332198141
Homepage URL
takamizawa.toshiki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Operative Dentistry, Nihon University School of Dentistry
Address
1-8-13 Kandasurugadai 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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 10 | 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
66
Results
The combination of at-home whitening with prefilled 6% hydrogen peroxide using a prefilled tray and in-office whitening with 35% hydrogen peroxide produced higher whitening efficacy than in-office whitening alone. At-home whitening with almost-daily usage between the in-office whitening intervals had better whitening efficacy than at-home whitening used occasionally. The tooth sensitivity during and after each whitening session showed a similar trend regardless of the whitening method employed.
Results date posted
| 2023 | Year | 01 | Month | 27 | 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
| 2021 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
However, color stability after dual whitening in this combination is unclear; therefore, further research is needed to investigate color stability through long-term observation.
Management information
Registered date
| 2023 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057136
