UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061179 |
|---|---|
| Receipt number | R000070010 |
| Scientific Title | An observational study on the evaluation of droplet distribution during oral and maxillofacial surgery using BHI agar plates |
| Date of disclosure of the study information | 2026/04/07 |
| Last modified on | 2026/04/07 10:20:50 |
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Basic information
Public title
A study investigating droplet spread during oral and maxillofacial surgery using BHI agar plates
Acronym
A study investigating droplet spread during oral and maxillofacial surgery
Scientific Title
An observational study on the evaluation of droplet distribution during oral and maxillofacial surgery using BHI agar plates
Scientific Title:Acronym
An observational study on droplet distribution during oral and maxillofacial surgery
Region
| Japan |
Condition
Condition
Impacted third molar
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the characteristics of droplet distribution during oral and maxillofacial surgery and to provide fundamental data that may contribute to the evaluation and improvement of current infection control measures.
Basic objectives2
Others
Basic objectives -Others
Assessment of droplet distribution during oral and maxillofacial surgery
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of colony-forming units (CFUs) at each sampling site during oral and maxillofacial surgery
Key secondary outcomes
Representative colonies will be selected for bacterial identification.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing bilateral maxillary and mandibular impacted third molar extraction under general anesthesia
Key exclusion criteria
Patients from whom informed consent for study participation cannot be obtained, and patients deemed inappropriate for participation by the investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Aiji |
| Middle name | |
| Last name | Sato |
Organization
Aichi Gakuin University School of Dentistry
Division name
Department of Anesthesiology, Dental Anesthesiology and Pain Medicine
Zip code
464-8651
Address
2-11 Suemoridori, Chikusa-ku, Nagoya-shi, Aichi, Japan
TEL
052-759-2111
bokuaiji@dpc.agu.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Kuroda |
Organization
Aichi Gakuin University School of Dentistry
Division name
Department of Anesthesiology, Dental Anesthesiology and Pain Medicine
Zip code
464-8651
Address
2-11 Suemoridori, Chikusa-ku, Nagoya-shi, Aichi, Japan
TEL
052-759-2111
Homepage URL
i.kuroda1824@gmail.com
Sponsor or person
Institute
Aichi Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Aichi Gakuin 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
Aichi Gakuin University School of Dentistry
Address
1-100 Kusumotocho, Chikusa-ku, Nagoya-shi, Aichi, Japan
Tel
052-751-2561
masui@dpc.agu.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 | 04 | Month | 07 | 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
| 2026 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study involving patients undergoing bilateral maxillary and mandibular impacted third molar extraction under general anesthesia. BHI agar plates will be placed at predefined locations in the operating room during oral and maxillofacial surgery, and the characteristics of droplet distribution will be evaluated by measuring the number of colony-forming units (CFUs) at each sampling site. In addition, representative colonies will be selected for bacterial identification. This study will be conducted within the scope of routine clinical practice, and no research intervention will be performed.
Management information
Registered date
| 2026 | Year | 04 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070010
