UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention study of steroid ointment therapy for ranula
Title of the study (Brief title)	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	Aoki Naofumi
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Oral and Maxillofacial Surgery
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL	(052)858-7302
Email	nao70231011@gmail.com

Public contact
Name of contact person	Senga Yasuko
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Oral and Maxillofacial Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030712