UMIN-ICDS Clinical Trial

Public title

Study to confirm safety of excessive use of functional water -Open method-

Acronym

Study to confirm safety of excessive use of functional water

Scientific Title

Study to confirm safety of excessive use of functional water -Open method-

Scientific Title:Acronym

Study to confirm safety of excessive use of functional water

Region

Japan

Condition

Healthy male/female volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In order to confirm the safety of high-precision hypochlorite water (research product) in 4 consecutive weeks of excessive use

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. interview
2. height
3. Weight (BMI)
4. blood pressure and pulse rate
5. hematology: white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, leukocytogram
6. biochemical tests: total protein, albumin, AST, ALT, LD (IFCC), total bilirubin, ALP (IFCC), gamma-GT, urea nitrogen (UN), creatinine, uric acid (UA), sodium (Na), chlor (Cl), potassium (K), calcium (Ca), total cholesterol, LDL-cholesterol, HDL-cholesterol, TG (triglycerides), glucose, HbA1c (NGSP)
7. Urinalysis: protein, sugar, urobilinogen, bilirubin, pH, specific gravity, urinary ketones, occult blood reaction
8. dental formula
9. gingivitis index (GI: Lee & Sillness, 1963)
10. dental plaque index (PlI: Silness & Loe, 1964)
11. oral mucosa
12. tooth coloration
13. Tongue Coating Index (photographic)
14. stimulated saliva volume/stimulated saliva pH
15. number of periodontopathogenic bacteria (A.actinomycetemcomitans, P.gingivalis, P.intermedia, T.forsythensis, T.denticola, F.nucleatum)
16. comprehensive analysis of flora in saliva (occupancy and diversity of each species by next generation sequencing)
17. caries-associated bacteria count (total strep, S. mutans, lactobacilli)
18. halitosis measurement (oral chroma: hydrogen sulfide, methyl mercaptan, dimethyl sulfide)
19. subjective and objective symptoms
20. adverse events

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Gargle with the test product 3 times a day, after each meal (after oral care)

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

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Japanese men and women between the ages of 20 and less than 65 years old
(2) Those who eat three meals a day regularly
(3) Those who have at least 4 of the following 6 teeth measurable on the labial and buccal sides: 16 (maxillary right first molar, FDI tooth code; same below), 12 (maxillary right lateral incisor), 24 (maxillary left first premolar), 36 (mandibular left first molar), 32 (mandibular left lateral incisor) and 44 (mandibular right first premolar).Or those who have FDI tooth codes 17, 15, 11, 25, 37, 35, 31, and 45 as substitutes for the aforementioned 6 representative teeth.
(4)Those who are not currently undergoing treatment for dental caries and periodontal disease and have at least 20 teeth.
(5) Those who have been fully informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a good understanding of the purpose and content of the study, and have agreed to participate in the study in writing.

Key exclusion criteria

(1)Those who are determined to have caries (C3 or higher) or severe periodontal disease at the time of screening examination.
(2) Those suffering from diabetes mellitus, chronic kidney disease, gastrointestinal disease, lung disease, malignant tumor, etc. and taking medication
(3) Those whose stimulated saliva volume for 5 minutes is less than 3.0 mL
(4) Those whose pH of stimulated saliva is less than 6.2
(5) Those who have ever been aware of food allergy
(6) Those who wear removable dentures.
(7)Those who have been diagnosed with dry mouth.
(8)Those who are undergoing orthodontic treatment.
(9) Those who regularly use water with a functional description.
(10)Those who are taking antibiotics or antibacterial agents or have taken them within 1 month of screening test
(11) Those who suffer from hay fever or allergic rhinitis and plan to take medications during the study period (excluding eye drops).
(12)Smokers
(13) Those who are pregnant, intend to become pregnant during the study period, or are breastfeeding.
(14) Those who are determined to be unsuitable as research subjects based on the results of tests performed during the screening test.
(15) those with a history or current medical history of drug or alcohol dependence
(16)Those who are currently participating in research involving the use of other foods or drugs, or the application of cosmetics or medicines, or those who have participated or intend to participate in other clinical research within one month of obtaining consent.
(17)Other persons who are deemed inappropriate as research subjects by the principal investigator.

Target sample size

20

Name of lead principal investigator

1st name	Tatsuo
Middle name
Last name	Yanagisawa

Organization

Yanagisawa Dental Office

Division name

Director

Zip code

171-0022

Address

1-18-1 minamiikebukuro,Toshima-ku, Tokyo

TEL

0339824790

Email

varitudo@kpe.biglobe.ne.jp

Name of contact person

1st name	Eiji
Middle name
Last name	Yoshikawa

Organization

KSO Corporation

Division name

Clinical Trial Management 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

eigyou27@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

Louis Pasteur Center for Medical Research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee of Kobuna Orthopedics Clinic

Address

5-656-17Joutou-machi,Maebashi-shi,Gunma

Tel

027-212-5608

Email

sagawa@mc-connect.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

柳澤デンタルオフィス

Date of disclosure of the study information

2024

Year

03

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

20

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

Recruitment status

No longer recruiting

Date of protocol fixation

2024

Year

02

Month

09

Day

Date of IRB

2023

Year

11

Month

09

Day

Anticipated trial start date

2024

Year

02

Month

25

Day

Last follow-up date

2024

Year

04

Month

07

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

03

Month

29

Day

Last modified on

2024

Year

03

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061654