UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030541 |
|---|---|
| Receipt number | R000034870 |
| Scientific Title | Comparative analyses of carbamylation and citrullination in relation to rheumatoid arthritis and periodontitis and their changes after periodontal treatment. |
| Date of disclosure of the study information | 2017/12/25 |
| Last modified on | 2021/01/31 14:37:51 |
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Basic information
Public title
Comparative analyses of carbamylation and citrullination in relation to rheumatoid arthritis and periodontitis and their changes after periodontal treatment.
Acronym
Comparative analyses of carbamylation and citrullination in relation to rheumatoid arthritis and periodontitis and their changes after periodontal treatment.
Scientific Title
Comparative analyses of carbamylation and citrullination in relation to rheumatoid arthritis and periodontitis and their changes after periodontal treatment.
Scientific Title:Acronym
Comparative analyses of carbamylation and citrullination in relation to rheumatoid arthritis and periodontitis and their changes after periodontal treatment.
Region
| Japan |
Condition
Condition
Rheumatoid arthritis and periodontitis
Classification by specialty
| Clinical immunology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To compare protein carbamylation and neutrophil extracellular traps (NETs) formation between patients with and without rheumatoid arthritis.
2) To compare protein carbamylation and neutrophil extracellular traps (NETs) formation before and after periodontal treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum levels of carbamylated protein and NETs
Key secondary outcomes
Probing depth, clinical attachment level, DAS28-CRP
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
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with rheumatoid arthritis and periodontitis
Key exclusion criteria
Having less than 15 teeth, the presence of diabetes mellitus or pregnancy, history or the presence of any periodontal and antibiotic treatment within the previous 3 months.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Kobayashi |
Organization
Niigata University Medical and Dental Hospital
Division name
General Dentistry and Clinical Education Unit
Zip code
951-8514
Address
2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan
TEL
025-227-2870
kotetsuo@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo |
| Middle name | |
| Last name | Kobayashi |
Organization
Niigata University Medical and Dental Hospital
Division name
General Dentistry and Clinical Education Unit
Zip code
951-8514
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan
TEL
025-227-2870
Homepage URL
kotetsuo@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Niigata University
Address
1-757 Asahimachi-Dori, Chuo-ku, Niigata, 951-8514, Japan
Tel
025-227-2870
kotetsuo@dent.niigata-u.ac.jp
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
| 2017 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
113
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 24 | Day |
Last modified on
| 2021 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034870
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
