UMIN-CTR Clinical Trial

Basic information
Public title	Confirmation trial about clinical/preventive effects of newly developed toothpaste against periodontal disease
Acronym	Confirmation trial about clinical/preventive effects of newly developed toothpaste against periodontal disease
Scientific Title	Confirmation trial about clinical/preventive effects of newly developed toothpaste against periodontal disease
Scientific Title:Acronym	Confirmation trial about clinical/preventive effects of newly developed toothpaste against periodontal disease
Region	Japan

Condition
Condition	Healthy male/female volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to evaluate periodontosis-inhibitory effects by test-product usage for 4 weeks
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Gingivitis index 2. Dental plaque index 3. Depth of periodontal pocket
Key secondary outcomes	1. Swelling 2. Reddening 3. Existence quantification of P. gingivalis / T. forsythia in saliva 4. Free Hb value / LDH activity in saliva 5. Overall effectiveness 6. Concentrations of volatile sulfur compounds, just like H2S and Me3SH 7. IL-1beta / IL-8 activity in saliva

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Continuous application of the toothpaste to the volunteers every daily meal for 4 weeks.
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	35 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy male/female volunteers ranging in age from 35 to 64 years old. (2) Volunteers having mild-to-moderate gingivitis. (3) According to the clinical observation, volunteers having not less than one periodontal pocket with not less than 4 mm. (4) At the screening test, volunteers who were determined as a patient having not less than one tooth equipped with level-1 or 2 on the GI index. (5) Volunteers having no scaling about the observation region within the last three months to the current trial. (6) Volunteers having meals three times a day, and toothbrushing after each meal. (7) Volunteers having not less than four teeth among measurable six ones (FDI: 16, 12, 24, 36, 32, 44), or their alternatives (FDI: 17, 15, 11, 25, 37, 35, 31, 45). (8) Volunteers equipped with not less than 20 teeth, and without some kind of periodontal disease. (9) Volunteers who gave informed consent to take part in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) At the screening test, volunteers who were determined as a patient having some dental caries (over C3 level) and/or severe periodontal disease. (2) Volunteers with medical treatment for diabetic, chronic kidney, digestive, lung or cancer diseases. (3) Volunteers having some kind of systemic disease, which has serious difficulty in participating this trial. (4) Volunteers with toothbrushing not less than four times a day, including the brushing before and after breakfast, before their normal bedtime, etc. (5) Pregnant, possibly pregnant, or lactating women, during this clinical trial. (6) Volunteers who are now under the other clinical trials with some kind of medicine/food, or willing to participate in similar tests. (7) Volunteers having their stimulating saliva with no more than 3.0 mL for 5 min. (8) Volunteers having stimulating saliva with no more than a pH of 6.2. (9) Volunteers with some kind of allergy. (10) Volunteers equipped with removable denture, and/or dental implant on the dental object. (11) Volunteers falling into the habit of smoking. (12) Volunteers who have regularly used some kind of health food. (13) Volunteers who have took in some kind of antibiotic and/or antibacterial agent, regularly or within the last month to the screening test. (14) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tomohiko Middle name Last name Yamaguchi
Organization	DAIICHI SANKYO HEALTHCARE CO., LTD
Division name	Chief Director
Zip code	140-8710
Address	3-14-10 Nihonbashi, Chuo-ku, Tokyo 140-8710, Japan
TEL	03-5225-6330
Email	yamaguchi.tomohiko.m6@daiichisankyo-hc.co.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	7F Shibaura-Omodaka Building, 1-9-7 Shibaura, Minato-ku, Tokyo 105-0023, Japan
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	DAIICHI SANKYO HEALTHCARE CO., LTD
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	Ethical Committee of Nihonbashi Cardiology Clinic
Address	Kyodo Building, 13-4-201 Nihonbashi-Kodenma-Cho, Chuo-ku, Tokyo 103-0001, Japan
Tel	03-5641-4133
Email	niho-jimucho@well-sleep.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	2022 Year 02 Month 07 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 11 Month 26 Day
Date of IRB	2020 Year 11 Month 18 Day
Anticipated trial start date	2021 Year 02 Month 07 Day
Last follow-up date	2021 Year 03 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	2021 Year 02 Month 02 Day
Last modified on	2021 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049278