UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054007 |
|---|---|
| Receipt number | R000061651 |
| Scientific Title | Study to confirm the effect of functional water in improving oral environment -Placebo-controlled, randomized, double-blind, parallel-group comparison- |
| Date of disclosure of the study information | 2024/03/29 |
| Last modified on | 2025/02/17 12:45:15 |
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Basic information
Public title
Study to confirm the effect of functional water in improving oral environment -Placebo-controlled, randomized, double-blind, parallel-group comparison-
Acronym
Study to confirm the effect of functional water in improving oral environment
Scientific Title
Study to confirm the effect of functional water in improving oral environment -Placebo-controlled, randomized, double-blind, parallel-group comparison-
Scientific Title:Acronym
Study to confirm the effect of functional water in improving oral environment
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 confirm the effect of improving oral environment by using high-precision hypochlorite water (research product) for 4 consecutive weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical parameters (gingivitis index(GI:Lee & Sillness, 1963), dental plaque index (PlI:Silness & Loe, 1964))
Key secondary outcomes
1. comprehensive analysis of flora in saliva (occupancy and diversity of each species by next generation sequencer)
2. caries-associated bacteria numbers (total streptococci, S. mutans, lactobacilli)
3. Number of periodontopathogenic bacteria (A.actinomycetemcomitans, P.gingivalis, P.intermedia, T.forsythensis, T.denticola, F.nucleatum)
4. Tongue Coating Index (photography)
5. halitosis measurement (oral chroma: hydrogen sulfide, methyl mercaptan, dimethyl sulfide)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
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
Gargle with control product 3 times a day after each meal (after oral care)
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
| 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
80
Research contact person
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
03-3982-4790
varitudo@kpe.biglobe.ne.jp
Public contact
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
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Louis Pasteur Center for Medical Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17Joutou-machi,Maebashi-shi,Gunma
Tel
027-212-5608
sagawa@mc-connect.co.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
柳澤デンタルオフィス
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 29 | 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
80
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
| 2024 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 04 | 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
| 2024 | Year | 03 | Month | 29 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061651
