UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the periodontal disease prevalence and risk in SLE patients, and infulence of periodontal treatment
Title of the study (Brief title)	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	Shigeki Makino
Organization	Osaka Medical College
Division name	Rheumatology, Department of Internal Medicine 1
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	Shuzo Yoshida
Organization	Osaka Medical College
Division name	Rheumatology, Department of Internal Medicine 1
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019593