UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020960
Receipt number R000024185
Scientific Title Investigation of the gingival characteristics.
Date of disclosure of the study information 2016/02/09
Last modified on 2017/02/09 16:26:03

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Basic information

Public title

Investigation of the gingival characteristics.

Acronym

Investigation of the gingival characteristics.

Scientific Title

Investigation of the gingival characteristics.

Scientific Title:Acronym

Investigation of the gingival characteristics.

Region

Japan


Condition

Condition

N/A

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To make a standard data of gingival characteristics of healthy gingiva such as hardness, thickness and color.

Basic objectives2

Others

Basic objectives -Others

To evaluate the effectiveness of the newly-developed device measuring hardness of gingiva.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The hardness, thickness and color of gingiva of anterior teeth.

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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

To evaluate hardness of gingiva by a newly-developed gingiva hardness measuring device.
To measure gingival thickness by ultrasonic measuring device.

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

periodontally healthy adults.

Key exclusion criteria

The person with inflamed gingiva, orthodontic evice, and systemic infectious diseases.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichi Izumi

Organization

Tokyo Medical and Dental University

Division name

Department of Periodontology

Zip code


Address

1-5-45 Yushima Bunkyo-ku Tokyo Japan

TEL

03-5803-5488

Email

y-izumi.peri@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuichi Izumi

Organization

Tokyo Medical and Dental university

Division name

Department of Periodontology

Zip code


Address

1-5-45 Yushima Bunkyo-ku Tokyo Japan

TEL

03-5803-5488

Homepage URL


Email

y-izumi.peri@tmd.ac.jp


Sponsor or person

Institute

Department of Periodontology, Graduate school of Tokyo Medical and Dental university

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

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

東京医科歯科大学歯学部附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 09 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

Terminated

Date of protocol fixation

2016 Year 02 Month 09 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 09 Day

Last follow-up date

2018 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

2016 Year 02 Month 09 Day

Last modified on

2017 Year 02 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024185


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name