UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034105 |
|---|---|
| Receipt number | 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 17:38:32 |
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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
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
mkouno@tdc.ac.jp
Sponsor or person
Institute
Department of Dermatology, Tokyo Dental College Ichikawa General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038831
