UMIN-CTR Clinical Trial

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
Email	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
Email	hoshiai.dpd@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035217