UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012408
Receipt number R000014523
Scientific Title Dental managements for patients undergoing cardiac transplantation-A retrospective study
Date of disclosure of the study information 2013/12/02
Last modified on 2023/06/16 17:33:41

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Basic information

Public title

Dental managements for patients undergoing cardiac transplantation-A retrospective study

Acronym

Dental managements for patients undergoing cardiac transplantation

Scientific Title

Dental managements for patients undergoing cardiac transplantation-A retrospective study

Scientific Title:Acronym

Dental managements for patients undergoing cardiac transplantation

Region

Japan


Condition

Condition

Cardiac transplantation

Classification by specialty

Cardiology Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

There are some risks such as hemorrhage and infection during surgical dental treatment (SDT) in the patients with a left ventricular assist device (LVAD). In the present study, SDT in cardiac transplantation patients were retrospectively investigated, and the adequate managements for SDT were suggested.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The dental management methods and prognosis of the patients undergoing cardiac transplantation

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

1 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

The pre-cardiac transplantation patients with LVAD, and those undergoing cardiac transplantation

Key exclusion criteria

The patients who are not scheduled for cardiac transplantation

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinari MORIMOTO

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Dentistry

Zip code


Address

5-7-1, Fujishirodai, Suita, Osaka, Japan

TEL

06-6833-5012

Email

ysn-mori@dent.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshinari MORIMOTO

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Dentistry

Zip code


Address

5-7-1, Fujishirodai, Suita, Osaka, Japan

TEL

06-6833-5012

Homepage URL


Email

ysn-mori@dent.osaka-u.ac.jp


Sponsor or person

Institute

National Cerebral and Cardiovascular Center

Institute

Department

Personal name



Funding Source

Organization

National Cerebral and Cardiovascular Center

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

2013 Year 12 Month 02 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

2013 Year 06 Month 19 Day

Date of IRB

2013 Year 07 Month 01 Day

Anticipated trial start date

2013 Year 12 Month 02 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

In the pre-cardiac transplantation patients with LVAD, post-therapeuteic hemorrhage was severe. In the postoperative patients, delay of wound healing and infection were critical.


Management information

Registered date

2013 Year 11 Month 26 Day

Last modified on

2023 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014523


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name