UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009875
Receipt number R000011571
Scientific Title A cross-over trial on a comparison of prosthodontics impression procedures for complete dentures.
Date of disclosure of the study information 2013/01/25
Last modified on 2015/08/21 19:26:48

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Basic information

Public title

A cross-over trial on a comparison of prosthodontics impression procedures for complete dentures.

Acronym

Survey of prosthodontics impression procedures for complete dentures.

Scientific Title

A cross-over trial on a comparison of prosthodontics impression procedures for complete dentures.

Scientific Title:Acronym

Survey of prosthodontics impression procedures for complete dentures.

Region

Japan


Condition

Condition

Edentulous

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the patient satisfaction and cost-utility analysis with 2 different techniques.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Patient-reported outcome

Key secondary outcomes

cost


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Final impression

Interventions/Control_2

Preliminary impression

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

-They need a new complete denture
-totally edentate patients
-denture wearers
-They can go to hospital themselves

Key exclusion criteria

-xerostomia
-temporomandibular disorders
-orofacial motor disorders
-dementia
-not denture wearers
-can not go to hospital themselves
-have psychiatric conditions
-impossible case to produce

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shunsuke Minakuchi

Organization

Tokyo Medical and Dental University

Division name

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

Zip code


Address

1-5-45 Yushima,Bunkyo-ku,Tokyo,113-8549,Japan

TEL

03-5803-5582

Email

s.minakuchi.gerd@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shunsuke Minakuchi

Organization

Tokyo Medical and Dental University

Division name

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

Zip code


Address

1-5-45 Yushima,Bunkyo-ku,Tokyo,113-8549,Japan

TEL

03-5803-5582

Homepage URL


Email

s.minakuchi.gerd@tmd.ac.jp


Sponsor or person

Institute

Shunsuke Minakuchi

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion Science

Organization

Division

Category of Funding 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

2013 Year 01 Month 25 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

2011 Year 07 Month 12 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 11 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

2013 Year 01 Month 25 Day

Last modified on

2015 Year 08 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011571


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name