UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037577
Receipt number R000042840
Scientific Title Examination of plaque removal efficiency using high density flocked electric toothbrush "Curaprox Hydrosonic Pro"
Date of disclosure of the study information 2019/12/31
Last modified on 2019/08/02 01:10:40

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Basic information

Public title

Research of electric toothbrush "Curaprox Hydrosonic Pro"

Acronym

Research of electric toothbrush

Scientific Title

Examination of plaque removal efficiency using high density flocked electric toothbrush "Curaprox Hydrosonic Pro"

Scientific Title:Acronym

Examination of plaque removal efficiency using electric toothbrush

Region

Japan


Condition

Condition

Healthy

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the plaque removal efficiency of various electric toothbrushes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Plaque index (PlI), Gingival index (GI),

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Using electric toothbrush "Curaprox Hydrosnic Pro" for teeth in quadrant

Interventions/Control_2

Using electric toothbrush "S" for teeth in quadrant

Interventions/Control_3

Using electric toothbrush "O" for teeth in quadrant

Interventions/Control_4

Using manual toothbrush "Curaprox" for teeth in quadrant

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

25 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

1.The staff at the department of periodontology at Tokyo Medical and Dental University (TMDU)
2. 20 or more remaining teeth

Key exclusion criteria

1. Having a serious systemic disease or infection
2. During pregnancy or nursing period
3. Having acute periodontal disease

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Yuichi
Middle name
Last name Ikeda

Organization

Tokyo Medical and dentalUniversity

Division name

Depertment of Periodontology

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5488

Email

ikeda.peri@tmd.ac.jp


Public contact

Name of contact person

1st name Yuichi
Middle name
Last name Ikeda

Organization

Tokyo Medical and dentalUniversity

Division name

Depertment of Periodontology

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5488

Homepage URL


Email

ikeda.peri@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

YOSHIDA DENTAL TRADE DISTRIBUTION CO., LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical and dentalUniversity

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

Tel

03-5803-5488

Email

ikeda.peri@tmd.ac.jp


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

東京医科歯科大学歯学部附属病院 歯周病外来


Other administrative information

Date of disclosure of the study information

2019 Year 12 Month 31 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

Preinitiation

Date of protocol fixation

2019 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 08 Month 02 Day

Last modified on

2019 Year 08 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042840


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name