UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045635 |
|---|---|
| Receipt number | R000052041 |
| Scientific Title | Effects of Local Cryotherapy and the background factor of a patient on hypercytokinemia after orthognathic surgery. |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/10/01 19:52:26 |
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Basic information
Public title
Effects of Local Cryotherapy and the background factor of a patient on hypercytokinemia after orthognathic surgery.
Acronym
Effects of Local Cryotherapy and the background factor of a patient on hypercytokinemia after orthognathic surgery.
Scientific Title
Effects of Local Cryotherapy and the background factor of a patient on hypercytokinemia after orthognathic surgery.
Scientific Title:Acronym
Effects of Local Cryotherapy and the background factor of a patient on hypercytokinemia after orthognathic surgery.
Region
| Japan |
Condition
Condition
Orthognathic Surgery
Cryotherapy Effect
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this trial is to determine if local cryotherapy after orthognathic surgery improves cytokines profile.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IL-6 protein level change postsurgical drainage fluid (before / after treatment)
Key secondary outcomes
pain Visual Analogic Scale change before / after treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
conventional compression with face mask.
Interventions/Control_2
a water-circulating mask by Hilotherm.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
After bilateral sagittal split osteotomy (BSSO)
Key exclusion criteria
Patients found to have previously diagnosed with systematic inflammatory disease, to have used steroids or non-steroidal anti-inflammatory drugs (NSAIDs) preoperatively were excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Sato |
Organization
Tsurumi University School of Dental Medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
2308501
Address
2-1-3 Tsurumi, Yokohama, Japan.
TEL
0455808332
sato-ki@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Sato |
Organization
Tsurumi University School of Dental Medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
2308501
Address
2-1-3 Tsurumi, Yokohama, Japan.
TEL
0455808332
Homepage URL
sato-ki@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi university hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Corporation
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of the Tsurumi University
Address
2-1-3 Tsurumi
Tel
0455808319
kyoken@tsurumi-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
| 2021 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.tsurumi-u.ac.jp/site/dental-hospital/index-2.html
Publication of results
Unpublished
Result
URL related to results and publications
http://ccs.tsurumi-u.ac.jp/oms/research.html
Number of participants that the trial has enrolled
24
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
An article under submission
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
| 2009 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2009 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | 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
| 2021 | Year | 10 | Month | 01 | Day |
Last modified on
| 2021 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052041
