UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054228 |
|---|---|
| Receipt number | R000061781 |
| Scientific Title | Appropriate use of antibiotics in the perioperative period for jaw deformity related intervention research |
| Date of disclosure of the study information | 2024/04/23 |
| Last modified on | 2024/04/23 07:59:17 |
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Basic information
Public title
Appropriate use of antibiotics in the perioperative period for jaw deformity related intervention research
Acronym
Intervention study of antibiotic use in jaw deformity
Scientific Title
Appropriate use of antibiotics in the perioperative period for jaw deformity related intervention research
Scientific Title:Acronym
Intervention study of antibiotic use in jaw deformity
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Antibiotic resistance (AMR) caused by overdosing of antibiotics in dentistry has become a problem. Particularly in major surgery, there are many facilities that do not distinguish between prophylactic and therapeutic administration and administer the drug for a long period of time. The purpose of this study was to evaluate and verify the postoperative healing process of jaw deformities depending on the usage of perioperative antibiotics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following items on the 1st, 3rd, 7th, 14th, and 28th days after surgery
Presence or absence of fever, presence or absence of cheek swelling, painless mouth opening, pain score (NRS), presence or absence of wound swelling, presence or absence of wound drainage.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
This study does not use any special test drugs or equipment.
Cefazolin sodium for injection (CEZ) used, the route of administration is intravenous injection, and the single dose is 1 g.
Single intraoperative administration group Single administration of CEZ 1g during maxillary osteotomy surgery
Multiple administration during and after surgery group CEZ 1g administered during maxillary osteotomy surgery, CEZ 1g administered twice in the morning and evening until the second postoperative day (2g/day)
Interventions/Control_2
Multiple administration during and after surgery group CEZ 1g administered during maxillary osteotomy surgery, CEZ 1g administered twice in the morning and evening until the second postoperative day (2g/day)
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects were cases in which maxillary and maxillary osteotomies (2 jaw surgery) were indicated in the preoperative evaluation. In addition, subjects with no signs of inflammation or symptoms in the jawbone area before surgery were included.
Key exclusion criteria
(Exclusion to affect effectiveness evaluation)
(1) Patients with diabetes or blood diseases
(2) Patients with inflammatory findings in the jawbone area, risk of infective endocarditis (IE), and risk of drug-induced osteonecrosis of the jaw (MRONJ)
(3) Patients taking steroids or immunosuppressive drugs
(4)Patients participating in other studies
(Exclusion to affect safety assessment)
(4) Patients with allergies to cephem antibiotics
(5) Patients who are taking anticoagulants, antithrombotic drugs, etc. and are at risk of bleeding
(6)Patients with renal dysfunction
(7) Women who are pregnant, may become pregnant, within 28 days after giving birth, or are breastfeeding.
(Exclusion from the perspective of risk/benefit balance)
(8) Patients who are judged to be difficult to participate in research due to psychosis or psychiatric symptoms
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Ezoe |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Oral and Maxillofacial Surgery
Zip code
980-8575
Address
4-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi Prefecture
TEL
0227178350
geka0329@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Ezoe |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Oral and Maxillofacial Surgery
Zip code
980-8575
Address
4-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi Prefecture
TEL
0227178350
Homepage URL
geka0329@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Division of Oral and Maxillofacial Surgery, Tohoku University Graduate School of Dentistry
Address
4-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi Prefecture
Tel
0227178350
geka0329@dent.tohoku.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 | 04 | Month | 23 | 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
| 2024 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 08 | 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
| 2024 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061781
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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