UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005968
Receipt number R000007052
Scientific Title An investigation into the adherence of bacterial florae to various abutment materials
Date of disclosure of the study information 2011/07/13
Last modified on 2013/07/05 08:59:53

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Basic information

Public title

An investigation into the adherence of bacterial florae to various abutment materials

Acronym

An investigation into the adherence of bacterial florae to various abutment materials

Scientific Title

An investigation into the adherence of bacterial florae to various abutment materials

Scientific Title:Acronym

An investigation into the adherence of bacterial florae to various abutment materials

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate plaques on various implant materials and reveal the factor affect an implant therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

florae

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are 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

Thirty subjects wear removable acrylic devices on which several kinds of disks are attached, for five days, except times for eating and toothbrushing.

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

25 years-old <=

Age-upper limit

35 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy subject apply to the age restriction above (25 to 35 years)

Key exclusion criteria

no informed consent
Bleeding tendency
History of diabetes
Use of Removable denture
Use of antibiotics
History of moderate to severe periodontitis

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kiyoshi Koyano

Organization

Faculty of Dental Science, Kyushu University

Division name

Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation

Zip code


Address

3-1-1, Maidashi, Higashi-ku, Fukuoka

TEL

092-642-6441

Email



Public contact

Name of contact person

1st name
Middle name
Last name Koichi Yamane

Organization

Faculty of Dental Science, Kyushu University

Division name

Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation

Zip code


Address


TEL


Homepage URL


Email

dd101054@dent.kyushu-u.ac.jp


Sponsor or person

Institute

Faculty of Dental Science, Kyushu University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

2011 Year 07 Month 13 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2010 Year 05 Month 26 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 01 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

2011 Year 07 Month 12 Day

Last modified on

2013 Year 07 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007052


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name