UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000017611
Receipt No. R000020350
Scientific Title Development and evaluation of a new toothbrush tailored for hemophiliacs with severe elbow arthropathy
Date of disclosure of the study information 2015/05/18
Last modified on 2017/06/05

* 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 Development and evaluation of a new toothbrush tailored for hemophiliacs with severe elbow arthropathy
Acronym Development and evaluation of a new toothbrush tailored for hemophiliacs with severe elbow arthropathy
Scientific Title Development and evaluation of a new toothbrush tailored for hemophiliacs with severe elbow arthropathy
Scientific Title:Acronym Development and evaluation of a new toothbrush tailored for hemophiliacs with severe elbow arthropathy
Region
Japan

Condition
Condition Hemophilia, HIV infection
Classification by specialty
Infectious disease Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate a custom-made toothbrush for the patients with elbow arthropathy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plaque Control Record (PCR), as described by O'Leary et al.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Patients use the custom-made toothbrush
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients or inpatients that are treated at National Center for Global Health and Medicine :
1) Patients with HIV infection
2) Patients with hemophilia
3) Patients with elbow arthropathy
Key exclusion criteria 1) Patients who transfer to a different hospital without treatment
2) Patients whose phycian consider the study enrollment inappropreate
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Oka
Organization National Center for Global Health and Medicine
Division name AIDS Clinical Center
Zip code
Address 1-21-1 Toyama, Shinjuku, 162-8655 Tokyo, Japan
TEL 03-3202-7181
Email soka@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumiko Nakagawa
Organization National Center for Global Health and Medicine
Division name AIDS Clinical Center
Zip code
Address 1-21-1 Toyama, Shinjuku, 162-8655 Tokyo, Japan
TEL 03-3202-7181
Homepage URL
Email y.nakagawa.526@gmail.com

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
2015 Year 05 Month 18 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
Results <Results>
The toothbrush handle was extended by 50-200 mm (median: 100 mm) depending on the severity of elbow joint deformity. The use of the custom-made toothbrush reduced pain during toothbrushing in all subjects. Oral hygiene also improved in all patients (PCR score) from 17-71% (median: 51%) at baseline to 15-40% (median: 38%) after the use. No adverse events were observed throughout this study.
<Conclusions>
In conclusion, a custom-made long-handle toothbrush was effective and safe for use by hemophiliac patients with severe elbow arthropathy to maintain oral hygiene.

Haemophilia 2015; 21: e481-e483.
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
2011 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 04 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 05 Month 18 Day
Last modified on
2017 Year 06 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020350

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.