UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030861 |
|---|---|
| Receipt number | R000035217 |
| Scientific Title | Investigation of Factors Influencing Oral Hygiene Management of Patients with Rheumatoid Arthritis. |
| Date of disclosure of the study information | 2018/01/17 |
| Last modified on | 2021/08/17 11:10:56 |
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Basic information
Public title
Investigation of Factors Influencing Oral Hygiene Management of Patients with Rheumatoid Arthritis.
Acronym
Investigation of Factors Influencing Oral Hygiene Management of Patients with Rheumatoid Arthritis.
Scientific Title
Investigation of Factors Influencing Oral Hygiene Management of Patients with Rheumatoid Arthritis.
Scientific Title:Acronym
Investigation of Factors Influencing Oral Hygiene Management of Patients with Rheumatoid Arthritis.
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the factors influencing oral hygiene management of patients with rheumatoid arthritis.
Basic objectives2
Others
Basic objectives -Others
Investigate the general condition by questionnaire and conduct intraoral examination.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health Assessment Questionnaire
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
1.Investigate the whole body condition and confirm the condition of treatment of rheumatoid arthritis.
2.Examine the extent of physical dysfunction.
3.Collect saliva samples.
4.Perform an intraoral examination.
5.Examine oral health behavior.
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
Patient with rheumatoid arthritis visiting Tokyo Medical and Dental University Dental Hospital.
Patients who have no abnormality in the oral cavity visiting a general dental clinic.
Key exclusion criteria
Patients who have serious systemic illness and are taking medications.
Patients with infectious diseases such as hepatitis and HIV.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Shinozuka |
Organization
Tokyo Medical and Dental University
Division name
Section of Dentistry for Persons with Disabilities
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5809-5727
o.shinozuka@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aiko Hoshiai |
Organization
Tokyo Medical and Dental University
Division name
Section of Dentistry for Persons with Disabilities
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5809-5555
Homepage URL
hoshiai.dpd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
| 2018 | Year | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 17 | Day |
Last modified on
| 2021 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035217
