UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028711
Receipt number R000032865
Scientific Title Investigation of prognostic indicators for complete denture therapy
Date of disclosure of the study information 2017/08/18
Last modified on 2019/03/11 19:56:59

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Basic information

Public title

Investigation of prognostic indicators for complete denture therapy

Acronym

The prognostic indicators for complete denture therapy

Scientific Title

Investigation of prognostic indicators for complete denture therapy

Scientific Title:Acronym

The prognostic indicators for complete denture therapy

Region

Japan


Condition

Condition

Edentulous patients

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To test the prognostic indicators for complete denture therapy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Oral Health Related Quality of Life (OHRQoL)

Key secondary outcomes

Denture satisfaction
Quality of denture
Ability of mastication


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

Device,equipment

Interventions/Control_1

Complete denture fabrication

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

Edentulous patients
Patients who wear complete denture.
Patients who wish to replace their complete denture.
Patients that can attend on their own.

Key exclusion criteria

Psychiatric disorders

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Shunsuke
Middle name
Last name Minakuchi

Organization

Tokyo Medical and Dental University

Division name

Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation

Zip code

113-8510

Address

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

TEL

03-5803-5586

Email

s.minakuchi.gerd@tmd.ac.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Sato

Organization

Tokyo Medical and Dental University

Division name

Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation

Zip code

113-8510

Address

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

TEL

03-5803-5586

Homepage URL

http://www.tmd.ac.jp/ore/top/research/research.html

Email

y.sato.gerd@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the Ethics Committee of Tokyo Medical and Dental University

Address

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

Tel

03-5803-7305

Email

d-hyoka.adm@cmn.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付属病院


Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 18 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://www.tmd.ac.jp/dept/dentistry/gerd/results/index.html

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

Open public recruiting

Date of protocol fixation

2008 Year 11 Month 30 Day

Date of IRB

2006 Year 07 Month 25 Day

Anticipated trial start date

2008 Year 12 Month 01 Day

Last follow-up date

2021 Year 12 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

2017 Year 08 Month 17 Day

Last modified on

2019 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032865


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name