UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057828 |
|---|---|
| Receipt number | R000066060 |
| Scientific Title | Analysis of microbiota and salivary proteins adhering to dental materials |
| Date of disclosure of the study information | 2025/05/12 |
| Last modified on | 2025/05/11 09:14:47 |
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Basic information
Public title
Analysis of microbiota and salivary proteins adhering to dental materials
Acronym
Analysis of microbiota and salivary proteins adhering to dental materials
Scientific Title
Analysis of microbiota and salivary proteins adhering to dental materials
Scientific Title:Acronym
Analysis of microbiota and salivary proteins adhering to dental materials
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analysis of microbiota adhering to hydroxyapatite and dental materials.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to analysis of microbiota adhering to hydroxyapatite and dental materials.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
microbiota adhering to hydroxyapatite and dental materials
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
| Maneuver |
Interventions/Control_1
Swab
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Age between 20 and 40 years old
2.Healthy adults
Key exclusion criteria
1. The people have not used antibiotics within one month
2. pregnant woman
3. metal allergy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomko |
| Middle name | |
| Last name | Ohshima |
Organization
Tsurumi University School of Dental Medicine
Division name
Oral Microbiology
Zip code
2308501
Address
2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi,Kanagawa-ken 230-8051
TEL
045-580-8440
ohshima-t@fs.tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Ohshima |
Organization
Tsurumi University School of Dental Medicine
Division name
Oral Microbiology
Zip code
2308501
Address
2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi,Kanagawa-ken 230-8051
TEL
045-580-8440
Homepage URL
ohshima-t@fs.tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Oral Microbiology, School of Dental Medicine, Tsurumi University
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohama City, 230-8501 Japan
Tel
0455808440
ohshima-t@fs.tsurumi-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
| 2025 | Year | 05 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 05 | Month | 11 | Day |
Last modified on
| 2025 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066060
