UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017611 |
|---|---|
| Receipt number | 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 23:30:31 |
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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
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
y.nakagawa.526@gmail.com
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
