UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041140 |
|---|---|
| Receipt number | R000046986 |
| Scientific Title | Effects of oral spray product containing 0.3 % cetylpyridinium chloride (CPC), applied after scaling and mechanical cleaning of tooth surface, on oral bacterial flora in adult volunteers. |
| Date of disclosure of the study information | 2020/07/22 |
| Last modified on | 2022/02/04 15:49:35 |
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Basic information
Public title
Effects of oral spray product containing 0.3 % cetylpyridinium chloride (CPC), applied after scaling and mechanical cleaning of tooth surface, on oral bacterial flora in adult volunteers.
Acronym
Monitoring of oral cleaning effects.
Scientific Title
Effects of oral spray product containing 0.3 % cetylpyridinium chloride (CPC), applied after scaling and mechanical cleaning of tooth surface, on oral bacterial flora in adult volunteers.
Scientific Title:Acronym
Effects of oral spray product containing 0.3 % cetylpyridinium chloride (CPC), applied after scaling and mechanical cleaning of tooth surface, on oral bacterial flora in adult volunteers.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm that the use of CPC spray maintains the oral bacterial flora after professional oral care [scaling (SC), professional mechanical tooth cleaning (PMTC)] in adult volunteers, by analyzing the 16S rRNA bacterial flora using saliva and tongue coat samples.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in oral bacterial flora on the next day of professional oral care (SC, PMTC), after 1 week and 3 weeks from starting the use of CPC spray.
Key secondary outcomes
Changes in total count of oral bacteria on the next day of professional oral care (SC, PMTC), after 1 week and 3 weeks from starting the use of CPC spray; and changes in Tongue Coating Index (TCI) from the first day of the study to 3 weeks after starting the use of CPC spray.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
After scaling (SC) and professional mechanical tooth cleaning (PMTC) by dental hygienists, subjects will use a CPC spray in addition to routine tooth brushing for 3 weeks.
Interventions/Control_2
After scaling (SC) and professional mechanical tooth cleaning (PMTC) by dental hygienists, subjects will continue routine tooth brushing for 3 weeks.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who provide a written informed consent for participation into the study.
Male and female subjects 30 to 60 years of age at the time of consent .
Subjects have more than 24 natural teeth, including teeth in upper/lower and left/right molar regions.
Key exclusion criteria
Subjects orally taking substances that may affect the oral bacterial flora (e.g. antimicrobials, antibiotics).
Subjects routinely using mouthwash, mouth rinse, interdental brush, and dental floss.
Subjects routinely cleaning their tongues.
Smokers.
Subjects receiving a treatment for diabetes mellitus.
Subjects planning dentist visits during the study period.
Pregnant or lactating women.
Subjects with a history of allergic reaction to the study product or its ingredients.
Subjects who have multiple caries (at least 5 C2 caries).
Subjects with severe periodontitis (e.g. with pus discharge or spontaneous bleeding).
Subjects determined by subinvestigators to be ineligible for inclusion in the study.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Haruko |
| Middle name | |
| Last name | Tobata |
Organization
Sunstar Inc. Shizuoka Innovation Center
Division name
R&D New Business
Zip code
411-0934
Address
The Medical and Health industry R&D Center of Shizuoka 2F, 1002-1, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-1686
haruko.tobata@jp.suntar.com
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Fujii |
Organization
Sunstar Inc. Shizuoka Innovation Center
Division name
R&D New Business
Zip code
411-0934
Address
The Medical and Health industry R&D Center of Shizuoka 2F, 1002-1, Shimonagakubo, Shizuoka, Japan
TEL
055-989-1686
Homepage URL
kana.fujii@jp.susntar.com
Sponsor or person
Institute
Sunstar Inc. Shizuoka Innovation Center
Institute
Department
Personal name
Funding Source
Organization
Sunstar Inc. Shizuoka Innovation Center
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
Japanese Society for Oral Health
Address
Kouku hoken kyokai 1-43-9 Komagome, Toshima, Tokyo, Japan
Tel
03-3947-8891
gakkai37@kokuhoken.or.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
一般財団法人サンスター財団附属千里歯科診療所（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 22 | 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
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 21 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 19 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 11 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 17 | Day |
Last modified on
| 2022 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046986
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