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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034105
Receipt No. R000038831
Scientific Title Analysis of oral microbiota in patients with autoimmune bullous dermatoses and oral lichen planus
Date of disclosure of the study information 2018/09/20
Last modified on 2018/09/07

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Basic information
Public title Analysis of oral microbiota in patients with autoimmune bullous dermatoses and oral lichen planus
Acronym Analysis of oral microbiota in patients with autoimmune bullous dermatoses and oral lichen planus
Scientific Title Analysis of oral microbiota in patients with autoimmune bullous dermatoses and oral lichen planus
Scientific Title:Acronym Analysis of oral microbiota in patients with autoimmune bullous dermatoses and oral lichen planus
Region
Japan

Condition
Condition Autoimmune bullous diseases, Oral lichen planus
Classification by specialty
Dermatology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To evaluate the changes of the oral microbiota in patients after oral care by dental hygienists.
2) To evaluate the efficacy of oral care and the relationship between disease severity and the changes of the oral microbiota.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of the oral microbiota at the first visit, 2 and 6 months later.
Key secondary outcomes Disease severity
Oral conditions (PD, PCR%, BOP)
Medication status
Clinical examination

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
Maneuver
Interventions/Control_1 Oral care by dental hygienists. (At the first visit and 1, 2, 4 and 6 months after the first visit.)
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 1) Patients with autoimmune bullous dermatoses and oral lichen planus.
2) Written informed consent provided for study participation.
Key exclusion criteria 1) Patients with other autoimmune diseases.
2) Patients regarded as inappropriate subjects for this study by principle investigator or cooperative medical doctor.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiyoshi Kouno
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Dermatology
Zip code
Address 5-11-13 Sugano ichikawa-shi, Chiba, Japan
TEL 047-322-0151
Email mkouno@tdc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michiyoshi Kouno
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Dermatology
Zip code
Address 5-11-13 Sugano Ichikawa-shi, Chiba, Japan
TEL 047-322-0151
Homepage URL
Email mkouno@tdc.ac.jp

Sponsor
Institute Department of Dermatology, Tokyo Dental College Ichikawa General Hospital
Institute
Department

Funding Source
Organization Tokyo Dental College
Organization
Division
Category of Funding Organization Other
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
2018 Year 09 Month 20 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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 20 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
2018 Year 09 Month 12 Day
Last modified on
2018 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038831

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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