UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062913 |
|---|---|
| Receipt number | R000072030 |
| Scientific Title | Evaluation of Oral Hygiene Management Methods Using Salivary Bacterial Counts as an Indicator Under Simulated Disaster Conditions |
| Date of disclosure of the study information | 2026/09/14 |
| Last modified on | 2026/09/14 12:07:35 |
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Basic information
Public title
Evaluation of Oral Hygiene Management Methods Using Salivary Bacterial Counts as an Indicator Under Simulated Disaster Conditions
Acronym
Disaster Oral Hygiene Study
Scientific Title
Evaluation of Oral Hygiene Management Methods Using Salivary Bacterial Counts as an Indicator Under Simulated Disaster Conditions
Scientific Title:Acronym
Disaster Salivary Bacteria and Oral Hygiene Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of oral hygiene management methods, including rinsing with a small amount of water, rinsing with mouthwash, and oral wiping with materials such as wet wipes, on salivary bacterial counts under simulated disaster conditions, and to evaluate feasible oral hygiene management methods that can be performed with limited water and resources.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in salivary bacterial counts before and after each oral hygiene management method
Key secondary outcomes
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants will undergo oral rinsing with a small amount of water, rinsing with mouthwash (e.g., Listerine), and oral wiping using materials such as wet wipes. Salivary bacterial counts will be measured before and after each intervention.
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult volunteers aged 18 years or older who understand the study and are able to provide written informed consent to participate of their own free will.
Key exclusion criteria
A history of hypersensitivity to the mouthwash or oral wiping materials used in the study, severe oral mucosal pain, inflammation, or ulceration, or those judged by the principal investigator to be unsuitable for participation in the study.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Funahara |
Organization
Kyushu Dental University
Division name
Department of Oral Health Sciences, Faculty of Dentistry
Zip code
803-8580
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka 803-8580, Japan
TEL
093-285-3042
r17funahara@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Funahara |
Organization
Kyushu Dental University
Division name
Department of Oral Health Sciences, Faculty of Dentistry
Zip code
803-8580
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka 803-8580, Japan
TEL
093-285-3042
Homepage URL
r17funahara@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
Kyushu Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu Dental University Research Ethics Committee
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka 803-8580, Japan
Tel
093-285-3011
gakusei@kyu-dent.ac.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
| 2026 | Year | 09 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 14 | Day |
Last modified on
| 2026 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072030
