UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050221 |
|---|---|
| Receipt number | R000057132 |
| Scientific Title | Efficacy test of the toothpaste effect on bacterial changes in dental plaque and on gingival condition (2023) |
| Date of disclosure of the study information | 2023/02/28 |
| Last modified on | 2023/02/02 17:16:04 |
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Basic information
Public title
Efficacy test of the toothpaste effect on bacterial changes in dental plaque and on gingival condition (2023)
Acronym
Efficacy test of the toothpaste effect on bacterial changes in dental plaque and on gingival condition (2023)
Scientific Title
Efficacy test of the toothpaste effect on bacterial changes in dental plaque and on gingival condition (2023)
Scientific Title:Acronym
Efficacy test of the toothpaste effect on bacterial changes in dental plaque and on gingival condition (2023)
Region
| Japan |
Condition
Condition
Gingivitis
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine changes in the condition of the gums due to the use of toothpaste
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The gingival condition after 4 weeks of use of control toothpaste or test toothpaste
Key secondary outcomes
Amount of bacteria in supragingival and subgingival plaque
Amount of dental plaque
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use test toothpaste at least twice a day.
Interventions/Control_2
Use control toothpaste at least twice a day.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Male and female aged 30-59
Key exclusion criteria
1. Person who do not intend to use the test product more than twice a day
2. Person who are hypersensitive to drugs such as allergies
3. Person who have five major diseases (cancer, stroke, acute myocardial infarction, diabetes, mental illness), etc. and are being treated at a medical institution, or who are scheduled for surgery, etc.
4. Pregnant women, those who may be pregnant, or those who are breastfeeding
5. Person who have taken antibiotics within one month
6. Person who are currently participating in clinical trials related to other oral cavities
7. Person who have had their teeth extracted or operated on periodontal disease within the past year
8. Person who are currently visiting a dental clinic and receiving oral treatment
9. Person who wear full dentures
10. Person who have obvious trauma in the oral cavity
11. Person who have severe gingival inflammation
12. Other persons who are judged by the dentist in charge of the test or the person in charge of the study to be inappropriate as a participant in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Okumura |
Organization
Kao Corporation
Division name
Personal Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9747
okumura.aya@kao.com
Public contact
Name of contact person
| 1st name | Kayo |
| Middle name | |
| Last name | Sato |
Organization
Kao Corporation
Division name
Personal Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9747
Homepage URL
satou.kayo2@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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 | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057132
