UMIN-CTR Clinical Trial

Basic information
Public title	Impact Assessment of toothpaste on gingiva(2)
Acronym	Impact Assessment of toothpaste on gingiva(2)
Scientific Title	Impact Assessment of toothpaste on gingiva(2)
Scientific Title:Acronym	Impact Assessment of toothpaste on gingiva(2)
Region	Japan

Condition
Condition	Periodontal disease
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of toothpaste for gingiva
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gingival index (GI)
Key secondary outcomes	-Probing pocket depth (PPD) -Attachment Loss (CAL) -Bleeding on probing (BOP) -Dental plaque -Intra oral photos -The situation of toothbrushing is video-recorded -Measurement of effective ingredients inside of gingival sulcus

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Toothbrushing with test toothpaste (1 or more times per day) for 2 months.
Interventions/Control_2	Toothbrushing with control toothpaste (1 or more times per day) for 2 months.
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	60 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Those who satisfy the entry criteria for this test in questionnaire survey at the time of subject requirement. 2) Healthy male and female who are 60 years old and more and less than 70 years old at the time of acquiring consent. 3) Those who can continuously use test toothpaste for 2 months and participate in the test including oral examination.
Key exclusion criteria	1) Subjects who received treatment of dental caries or periodontal disease in dental clinic 2) Subjects with serious wound in the oral cavity 3) Subjects with acute inflammation of the gingiva 4) Subjects with tooth mobility 5) Severe periodontitis patients
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hidetake Middle name Last name Fujinaka
Organization	Kao Corporation
Division name	R&D-Development Research-Personal Health Care Products Research
Zip code	131-8501
Address	2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL	03-5630-9751
Email	fujinaka.hidetake@kao.co.jp

Public contact
Name of contact person	1st name Kayo Middle name Last name Sato
Organization	Kao Corporation
Division name	R&D-Development Research-Personal Health Care Products Research
Zip code	131-8501
Address	2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL	03-5630-9751
Homepage URL
Email	satou.kayo2@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

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	03-5630-9786
Email	uesaka.toshio@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	花王株式会社（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 01 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	36
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	2017 Year 10 Month 10 Day
Date of IRB	2017 Year 10 Month 10 Day
Anticipated trial start date	2017 Year 10 Month 10 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 04 Day
Last modified on	2019 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033165