UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061397 |
|---|---|
| Receipt number | R000070247 |
| Scientific Title | Perioperative management through perioperative oral function management |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/28 08:43:11 |
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Basic information
Public title
Prevention of postoperative infection through oral care
Acronym
The effects of oral care
Scientific Title
Perioperative management through perioperative oral function management
Scientific Title:Acronym
Perioperative management through perioperative oral function management
Region
| Japan |
Condition
Condition
Head and neck region, respiratory region, digestive region, cardiovascular region, orthopedics, organ transplantation surgery, hematopoietic stem cell transplantation, stroke, breast
Classification by specialty
| Endocrinology and Metabolism | Surgery in general | Gastrointestinal surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Orthopedics | Oral surgery |
| Neurosurgery | Cardiovascular surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Perioperative oral function management is covered by health insurance. However, its history is short, and much about its effectiveness remains unknown. Therefore, this study will examine the various effects of perioperative oral function management during surgery and chemoradiotherapy for diseases that are covered by health insurance.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
This study targets patients in the perioperative period. Data and samples will be collected before, immediately after, and upon discharge of surgery or chemoradiotherapy. Samples will include saliva, blood, and a portion of an organ removed during surgery. Oral examinations, including periodontal disease screening, blood test results, and fever data will be extracted from medical records.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Perioperative oral function management is provided to patients undergoing surgery or chemoradiotherapy.
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
| 18 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing surgery or chemoradiotherapy
Key exclusion criteria
Patients who have previously received perioperative oral function management through other procedures.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tamaki |
| Middle name | |
| Last name | Naofumi |
Organization
Kagoshima university
Division name
Department of preventive dentistry
Zip code
8908544
Address
8-35-1, sakuragaoka, kagoshima city
TEL
0992756182
tamanaof@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tamaki |
| Middle name | |
| Last name | Naofumi |
Organization
Kagoshima university
Division name
Department of preventive dentistry
Zip code
8908544
Address
8-35-1, sakuragaoka, kagoshima city
TEL
0992756182
Homepage URL
tamanaof@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Kagoshima university
Address
8-35-1, sakuragaoka, kagoshima city
Tel
0992756182
tamanaof@dent.kagoshima-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
| 2026 | Year | 05 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2034 | 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
| 2026 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070247
