UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057420 |
|---|---|
| Receipt number | R000064983 |
| Scientific Title | Development of Dental Material Surface Treatment Based on Oral Bacterial Dynamics |
| Date of disclosure of the study information | 2025/03/27 |
| Last modified on | 2025/03/27 14:23:20 |
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Basic information
Public title
Development of Dental Material Surface Treatment Based on Oral Bacterial Dynamics
Acronym
Development of Dental Material Surface Treatment Based on Oral Bacterial Dynamics
Scientific Title
Development of Dental Material Surface Treatment Based on Oral Bacterial Dynamics
Scientific Title:Acronym
Development of Dental Material Surface Treatment Based on Oral Bacterial Dynamics
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A custom-made mouthpiece was fitted to healthy adults to evaluate the oral microbiota.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of biofilm adhered was quantitatively evaluated at 12 hours, 1 day, and 3 days after the mouthpiece was fitted.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Wear special mouthpiece
Interventions/Control_2
Wear control mouthpiece
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Possessing a full set of teeth.
No sites with a periodontal pocket depth exceeding 3 mm.
No dental caries (cavities).
No history of smoking.
No history of antibiotic treatment within the past 6 months.
Key exclusion criteria
Being pregnant.
Having a systemic disease.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Komatsu |
Organization
Institute of Science Tokyo
Division name
Lifetime Oral Health Care Sciences
Zip code
113-8510
Address
Bunkyo-ku, Yushima, 1-5-45
TEL
03-5803-4968
komatsu.peri@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Komatsu |
Organization
Institute of Science Tokyo
Division name
Lifetime Oral Health Care Sciences
Zip code
113-8510
Address
Bunkyo-ku, Yushima, 1-5-45
TEL
03-5803-4968
Homepage URL
komatsu.peri@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Lifetime Oral Health Care Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Ethical Committee of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, TOKYO , 113-8549, JAPAN
Tel
03-5803-5404
d-hyoka.adm@tmd.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 | 03 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | 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
| 2025 | Year | 03 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064983
