UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055671 |
|---|---|
| Receipt number | R000063518 |
| Scientific Title | Research on changes in the oral environment and oral flora through oral care education |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/10/08 19:07:22 |
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Basic information
Public title
Research on changes in oral environment through oral care education
Acronym
Effects of oral care education on the oral environment
Scientific Title
Research on changes in the oral environment and oral flora through oral care education
Scientific Title:Acronym
Effects of oral care on the oral environment
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nationwide, the dental examination rate is lower than the medical examination rate, and Aomori Prefecture's rate has not kept up with the national average. In order to increase the rate of dental examination, the Aomori University Faculty of Pharmacy has introduced "oral care" into its curriculum with the support of the Japanese Society of Oral Care. Specifically, we provide oral care lectures, practical brushing instruction, and oral environment measurements (including changes in oral flora). The purpose of this study is to analyze the impact of this "oral care education (including practical brushing instruction)" on "changes in the oral environment and oral flora (bacterial flora)" using human saliva. The results will reveal the state of the oral environment of Aomori Prefecture residents, and will be presented at academic conferences, etc., with the aim of improving the dental examination rate in Aomori Prefecture.
Basic objectives2
Others
Basic objectives -Others
It is assumed that implementing oral care may improve the oral environment and is also beneficial for cooperators. You can know the subsequent oral environment status (presence of cariogenic bacteria, acidity, buffering capacity, gum protein, presence of white blood cells, oral ammonia) for free.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Research on changes in oral flora uses saliva collected at the first time, one month, and three months after the oral environment measurement. Analyze the bacterial and fungal flora in saliva (oral flora) and find out what kinds of bacteria are common in saliva. We will outsource some of the analysis to Kochi University's Genetic Experiment Facility.
Key secondary outcomes
First, we will collect saliva and measure the oral environment. Afterwards, the examinee will be asked to watch a recording of oral care education (including practical brushing instruction) and perform brushing for 3 months. We will also ask the examinee to keep a record of their oral care implementation status (attached) for three months. Saliva samples will be collected again after 1 and 3 months to measure the oral environment. The principal investigator, who is a dentist, will examine the examinee 's saliva using an oral environment measuring device.
To collect saliva, have the examinee put saline in their mouth, rinse for 10 seconds, and then spit into a spitz (or paper cup). After rinsing for 10 seconds, Then, collect the saline rinsed for 10 seconds with a dropper and measure it using an oral environment measuring device.
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
First, we will collect saliva and measure the oral environment. Afterwards, the examinee will be asked to watch a recording of oral care education (including practical brushing instruction) and perform brushing for 3 months. We will also ask the examinee to keep a record of their oral care implementation status for three months. For example, number of brushings per day. Saliva samples will be collected again after 1 and 3 months to measure the oral environment.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
30 adults (15 men, 15 women) who are interested in oral care education (including practical brushing instruction).
Key exclusion criteria
Exclusion conditions include those suffering from severe respiratory illnesses or infectious diseases.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsurou |
| Middle name | |
| Last name | Ikeda |
Organization
Aomori University
Division name
Faculty of Pharmacy
Zip code
030-0943
Address
2-3-1 Kobata Aomori-city
TEL
017-738-2001
t.ikeda@aomori-u.ac.jp
Public contact
Name of contact person
| 1st name | Rueko |
| Middle name | |
| Last name | Sakamoto |
Organization
Aomori University
Division name
General Affairs Division
Zip code
030-0943
Address
2-3-1 Kobata Aomori-city
TEL
017-738-2001
Homepage URL
sakamoto@aomori-u.ac.jp
Sponsor or person
Institute
Aomori University
Institute
Department
Personal name
Funding Source
Organization
Koeki zaidan hojin Aomori gakujutsu bunka shinko zaidan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aomori University Medical Ethics Committee
Address
2-3-1 Kobata Aomori-City
Tel
017-738-2001
sakamoto@aomori-u.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
| 2024 | 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
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063518
