UMIN-CTR Clinical Trial

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
Email	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
Email	kana.fujii@jp.susntar.com

Sponsor
Institute	Sunstar Inc. Shizuoka Innovation Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046986