UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the influence that periodontal disease treatment gives pathophysiology of rheumatoid arthritis
Title of the study (Brief title)	Study of the influence that periodontal disease treatment gives pathophysiology of rheumatoid arthritis
Region	Japan

Condition
Condition	rheumatoid arthritis
Classification by specialty	Clinical immunology Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the influence by giving periodontal treatment parallel to treatment of rheumatoid arthritis(RA) for RA patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	significant difference of the disease activity between the start of therapy and 12 weeks later therapy at 48 weeks
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	periodontal disease 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	1 The patients who were newly diagnosised RA and who does not receive treatment of RA 2 The patients who had been diagnosised RA and who has received treatment of RA
Key exclusion criteria	Patients who has been to dental office for 6 months
Target sample size	200

Research contact person
Name of lead principal investigator	Shigeki Makino
Organization	Osaka Medical College
Division name	Internal Medicine
Address	2-7 Daigakumachi Takatsuki city Osaka Japan
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	Internal Medicine
Address	2-7 Daigakumachi Takatsuki city Osaka Japan
TEL	072-683-1221
Homepage URL
Email	in1307@poh.osaka-med.ac.jp

Sponsor
Institute	Internal Medicine Osaka Medical College
Institute
Department

Funding Source
Organization	Internal Medicine Osaka Medical College
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 17 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 05 Month 10 Day
Anticipated trial start date	2015 Year 06 Month 18 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 06 Month 17 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=R000020810