UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049832 |
|---|---|
| Receipt number | R000056692 |
| Scientific Title | Exploratory research on the ability of surface-modified titanium to collect oral microorganisms |
| Date of disclosure of the study information | 2022/12/19 |
| Last modified on | 2022/12/19 18:55:00 |
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Basic information
Public title
Exploratory research on the ability of surface-modified titanium to collect oral microorganisms
Acronym
Modified titanium antibacterial test
Scientific Title
Exploratory research on the ability of surface-modified titanium to collect oral microorganisms
Scientific Title:Acronym
Modified titanium antibacterial evaluation
Region
| Japan |
Condition
Condition
periodontaitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the highly efficient microbial collection and antibacterial properties of acid-treated titanium sheets.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of collected bacteria and amount of viable bacteria
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Bacteria collection sheet
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Adults aged 20 years or older at the time of informed consent
2) Persons who have given written informed consent of their own free will after receiving a sufficient explanation for participating in this research.
3) Patients with periodontal disease (periodontitis) or healthy subjects with normal periodontal conditions
Key exclusion criteria
1) People with diseases other than periodontal disease (diabetes, digestive system disease, nasopharyngeal system disease, tongue coating, xerostomia, dental caries, etc.)
2) People with a strong vomiting reflex
3) Women who are pregnant or may become pregnant
4) Lactating women
5) In addition, patients who are judged to be inappropriate as research subjects by the principal investigator or co-investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama University
Division name
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-6667
tmatsu@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama University
Division name
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-6667
Homepage URL
https://www.okayama-u.ac.jp/user/biomat/
tmatsu@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Takuya Matsumoto
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
N/A
Name of secondary funder(s)
N/A
IRB Contact (For public release)
Organization
Okayama University
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-6667
tmatsu@md.okayama-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
N/A
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 19 | 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
40
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
| 2022 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 12 | Month | 19 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056692
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
