UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059618 |
|---|---|
| Receipt number | R000068195 |
| Scientific Title | The effect of oral hygiene on complications after orthopedic surgery |
| Date of disclosure of the study information | 2025/11/02 |
| Last modified on | 2025/11/02 09:54:50 |
* 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
The effect of oral hygiene on complications after orthopedic surgery
Acronym
The effect of oral hygiene on complications after orthopedic surgery
Scientific Title
The effect of oral hygiene on complications after orthopedic surgery
Scientific Title:Acronym
The effect of oral hygiene on complications after orthopedic surgery
Region
| Japan |
Condition
Condition
Patients who have undergone knee replacement, hip replacement, or spinal surgery
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to investigate the effect of preoperative oral hygiene on complications after orthopedic surgery.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clavien Dindo
Key secondary outcomes
Length of hospital stay
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 65 years or older (because they have had a preoperative oral hygiene assessment) and patients undergoing elective surgery (because they have had a preoperative oral hygiene assessment)
Key exclusion criteria
Patients who refused to participate in the study by opting out
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ida |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
6348521
Address
840 Shijo Kashihara
TEL
0744223051
nwnh0131@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | MITSURU |
| Middle name | |
| Last name | IDA |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
6348521
Address
840 Shijo Kashihara
TEL
0744223051
Homepage URL
nwnh0131@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board of Nara Medical University
Address
Kashihara, Nara, Japan
Tel
074485213054
nwnh0131@naramed-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
| 2025 | Year | 11 | Month | 02 | 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 | 11 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068195
