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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017008
Receipt No. R000019593
Scientific Title Study of the periodontal disease prevalence and risk in SLE patients, and infulence of periodontal treatment
Date of disclosure of the study information 2015/04/01
Last modified on 2018/05/17

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Basic information
Public title Study of the periodontal disease prevalence and risk in SLE patients, and infulence of periodontal treatment
Acronym Study of the periodontal disease prevalence and risk in SLE patients, and infulence of periodontal treatment
Scientific Title Study of the periodontal disease prevalence and risk in SLE patients, and infulence of periodontal treatment
Scientific Title:Acronym Study of the periodontal disease prevalence and risk in SLE patients, and infulence of periodontal treatment
Region
Japan

Condition
Condition systemic lupus erythematosus
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine influence that periodontal disease treatment gives in SLE
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SLEDAI in 24weeks
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 periodontal 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 Female
Key inclusion criteria 1. SLE patients
2. PSL dose >= 20mg/day
Key exclusion criteria Patients who have visited dentists for 6 months
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeki Makino
Organization Osaka Medical College
Division name Rheumatology, Department of Internal Medicine 1
Zip code
Address 2-7, daigaku-machi, Takatsuki-city, Osaka
TEL 072-683-1221
Email in1246@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuzo Yoshida
Organization Osaka Medical College
Division name Rheumatology, Department of Internal Medicine 1
Zip code
Address 2-7, daigaku-machi, Takatsuki-city, Osaka
TEL 072-683-1221
Homepage URL
Email in1307@poh.osaka-med.ac.jp

Sponsor
Institute Rheumatology, Department of Internal Medicine 1, Osaka Medical College
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor non
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 大阪医科大学(大阪府)

Other administrative information
Date of disclosure of the study information
2015 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 No longer recruiting
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 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
2015 Year 04 Month 01 Day
Last modified on
2018 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019593

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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