UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054855 |
|---|---|
| Receipt number | R000062679 |
| Scientific Title | Changes in oral bacterial counts and factors influencing the increase in bacterial counts in post-oral surgery patients |
| Date of disclosure of the study information | 2024/07/08 |
| Last modified on | 2026/01/07 10:33:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Changes in oral bacterial counts and factors influencing the increase in bacterial counts in post-oral surgery patients
Acronym
Oral surgery and factors increasing oral bacteria
Scientific Title
Changes in oral bacterial counts and factors influencing the increase in bacterial counts in post-oral surgery patients
Scientific Title:Acronym
Oral surgery and factors increasing oral bacteria
Region
| Japan |
Condition
Condition
Oral surgery
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify salivary bacterial counts in oral surgery patients before surgery, during the postoperative tube feeding period, and when oral feeding (liquid and solid foods) is initiated. In addition, factors associated with changes in bacterial counts will be analyzed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial count in saliva
Each item collected as patient background
Key secondary outcomes
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 6 years or older who underwent surgery under general anesthesia at Nagasaki University Hospital, Aichi-Gakuin University Dental Hospital, or Kanagawa Dental University Hospital between the date of study approval and April 30, 2025, and are scheduled for tube feeding for a certain period after surgery.
2. Patients who have given their consent to participate in this study.
Key exclusion criteria
1. Patients managed with a postoperative tracheostomy or intubation
2. Patients with severe cognitive impairment
3. Patients with severe xerostomia
4. Other patients who are deemed inappropriate as research subjects by the investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University
Division name
Preventive Dentistry
Zip code
852-8588
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7663
sakiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University
Division name
Preventive Dentistry
Zip code
852-8588
Address
1-7-1, Sakamoto,
TEL
+818017063341
Homepage URL
sakiko@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki 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
Institution Review Bpard of Nagasaki University Hospital
Address
1-7-1, Sakamoto, Nagasaki
Tel
0958197229
gaibushikin@ml.nagasaki-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 | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062679
