UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017955 |
|---|---|
| Receipt number | R000020810 |
| Scientific Title | Study of the influence that periodontal disease treatment gives pathophysiology of rheumatoid arthritis |
| Date of disclosure of the study information | 2015/06/17 |
| Last modified on | 2018/05/17 11:54:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of the influence that periodontal disease treatment gives pathophysiology of rheumatoid arthritis
Acronym
Study of the influence that periodontal disease treatment gives pathophysiology of rheumatoid arthritis
Scientific Title
Study of the influence that periodontal disease treatment gives pathophysiology of rheumatoid arthritis
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shigeki Makino |
Organization
Osaka Medical College
Division name
Internal Medicine
Zip code
Address
2-7 Daigakumachi Takatsuki city Osaka Japan
TEL
072-683-1221
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
Internal Medicine
Zip code
Address
2-7 Daigakumachi Takatsuki city Osaka Japan
TEL
072-683-1221
Homepage URL
in1307@poh.osaka-med.ac.jp
Sponsor or person
Institute
Internal Medicine Osaka Medical College
Institute
Department
Personal name
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)
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
| 2015 | Year | 06 | Month | 17 | 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 | 05 | Month | 10 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020810
