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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026751
Receipt No. R000030712
Scientific Title Intervention study of steroid ointment therapy for ranula
Date of disclosure of the study information 2017/04/01
Last modified on 2017/10/19

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Basic information
Public title Intervention study of steroid ointment therapy for ranula
Acronym Intervention study of steroid ointment therapy for ranula
Scientific Title Intervention study of steroid ointment therapy for ranula
Scientific Title:Acronym Intervention study of steroid ointment therapy for ranula
Region
Japan

Condition
Condition ranula
Classification by specialty
Oral surgery Dental medicine Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine an effect of steroid ointment therapy for ranula
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes recurrence rate of ranula for one year after this examine
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Applying ointment four times a day for three days
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1, All ages. Male and Female
2, Oral ranula and Plunging ranula with associated intraoral swelling
3, Hospitalized patient and Outpatient
4, The person who receives a consent for the documentary participation in this study.
Key exclusion criteria 1, Patients with hypersensitivity of Dexartin oral ointment
2, Patients with pituitary/adrenal cortical disease
3, Patients receiving treatment such as steroid internal administration, drip, inhalation etc. during this study
4, The person who cannot apply steroid ointment
5, Patients not appropriate for using electrocautery
6, The person whom a doctor disqualifyied for this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Aoki Naofumi
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address 1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL (052)858-7302
Email nao70231011@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Senga Yasuko
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address 1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL (052)858-7302
Homepage URL
Email senga_ruhuna@yahoo.co.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Department of Oral and Maxillofacial Surgery
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 04 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 29 Day
Last modified on
2017 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030712

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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