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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000045635
Receipt No. 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

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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
Email 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
Email sato-ki@tsurumi-u.ac.jp

Sponsor
Institute Tsurumi university hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052041

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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