UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development and evaluation of a new toothbrush tailored for hemophiliacs with severe elbow arthropathy
Title of the study (Brief title)	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	Shinichi Oka
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
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	Yumiko Nakagawa
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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.
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020350