World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-UMIN000013750
Date of registration: 21/04/2014
Prospective Registration: No
Primary sponsor: Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences
Public title: Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis
Scientific title:
Date of first enrolment: 2011/07/31
Target sample size: 80
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016046
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Hiromasa Yoshie   
Address:  2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan Japan
Telephone: 025-227-2869
Email: yoshie@dent.niigata-u.ac.jp
Affiliation:  Niigata University Graduate School of Medical and Dental Sciences Division of Periodontology
Name: Tetsuo Kobayashi   
Address:  2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan Japan
Telephone: 025-227-2870
Email: kotetsuo@dent.niigata-u.ac.jp
Affiliation:  Niigata University Medical and Dental Hospital General Dentistry and Clinical Education Unit
Key inclusion & exclusion criteria
Inclusion criteria: 1. Individuals whose consents are obtained in written form on participation in the present study.
2. Individuals with rheumatoid arthritis who have a minimum of 20 teeth.

Exclusion criteria: 1.Individuals who had received scaling and root planing within the previous 3 months before the study starts.
2.Individuals who had taken systemic antibiotics or anti-inflammatory drugs within 3 months before the study starts.
3.Individuals with severe systemic diseases
4.Individuals who are or suspected to be pregnant.
5.Individuals who are considered not eligible for the present study due to any reasons by the investigators.


Age minimum: Not applicable
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis, Periodontitis
Intervention(s)
IL-6 receptor inhibition group:
Tocilizumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.

TNF inhibition group:
Infliximab, Etanercept, and Adalimumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.
Primary Outcome(s)
Gingival index
Bleeding on probing
Probing pocket depth
Clinical attachment level
Secondary Outcome(s)
Serum markers
hsCRP
IL-6
TNF-alpha
MMP-3
Secondary ID(s)
Source(s) of Monetary Support
Japan Society for the Promotion of Science
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history