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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034046
Receipt No. R000038794
Scientific Title Clinical study of the effectiveness of the SORB'S Oral Wash and Tooth Paste for the treatment of Oral lichen planus
Date of disclosure of the study information 2018/10/01
Last modified on 2019/05/01

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Basic information
Public title Clinical study of the effectiveness of the SORB'S Oral Wash and Tooth Paste for the treatment of Oral lichen planus
Acronym Clinical study of the effectiveness of the SORB'S Oral Wash and Tooth Paste for the treatment of Oral lichen planus
Scientific Title Clinical study of the effectiveness of the SORB'S Oral Wash and Tooth Paste for the treatment of Oral lichen planus
Scientific Title:Acronym Clinical study of the effectiveness of the SORB'S Oral Wash and Tooth Paste for the treatment of Oral lichen planus
Region
Japan

Condition
Condition Oral lichen planus
Classification by specialty
Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of the SORB'S Oral Wash and Tooth Paste for the treatment of Oral lichen planus
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The degree of pain is assessed at baseline and at the three months after starting the treatment
Key secondary outcomes The clinical appearance is assessed at baseline and at the three months after starting the treatment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Using SORB'S Tooth Paste in case of a tooothbrush and oral rinse by SORB'S Oral wash once a day for three months after starting the treatment
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects are enrolled from the patients attending the department of Oral surgery, Tokyo Medical and Dental University, Dental hospital, who had a diagnosis of Oral lichen planus, and agreed to the consent for this study
Key exclusion criteria the patients are a minor, and can not be given effective informed consent for this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name HARADA
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Oral and Maxillofacial Surgery
Zip code 1138549
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 0358035508
Email hiro-harada.osur@tmd.ac.jp

Public contact
Name of contact person
1st name Fumihiko
Middle name
Last name TSUSHIMA
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Oral and Maxillofacial Surgery
Zip code 1138549
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 0358035508
Homepage URL http://www.dent.tmd.ac.jp/organization/osur.html
Email ft.osur@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Integrate Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

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

IRB Contact (For public release)
Organization Ethical Committee of Tokyo Medical and Dental University
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel 0358035404
Email ft.osur@tmd.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 東京医科歯科大学歯学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 10 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 5
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 Completed
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
2018 Year 08 Month 27 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 09 Month 05 Day
Last modified on
2019 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038794

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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