UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031164
Receipt number R000035529
Scientific Title The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial
Date of disclosure of the study information 2018/02/06
Last modified on 2018/06/12 09:26:27

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Basic information

Public title

The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial

Acronym

The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial

Scientific Title

The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial

Scientific Title:Acronym

The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial

Region

Japan


Condition

Condition

Edentulous Patients

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of porcelain teeth in complete dentures

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Oral health related Quality of Life (OHIP-EDENT)
(3months after insertion of complete dentures)

Key secondary outcomes

satisfaction
masticatory performance
occlusal force


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

porcelain teeth

Interventions/Control_2

hard resin teeth

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

Patients with complete dentures

Key exclusion criteria

severe alveolar rigde resorption, Maxillofacial Prothetics, severe xerostomia

Target sample size

52


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsuro Yokoyama

Organization

Graduate school of Dental Medicine,Hokkaido University

Division name

Department of Oral functional Prothodontics

Zip code


Address

Nishi-7, Kita-13, Kita-Ku, Sapporo, Japan

TEL

011-706-4270

Email

yokoyama@den.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshifumi Nogawa

Organization

Hokkaido University Hospital

Division name

Clinical research and medical innovation center

Zip code


Address

Nishi-5, Kita-14, Kita-Ku, Sapporo, Japan

TEL

011-706-7935

Homepage URL


Email

t.nogawa@den.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

Shofu Inc.

Organization

Division

Category of Funding Organization

Profit organization

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

北海道大学病院(北海道)


Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 06 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

Enrolling by invitation

Date of protocol fixation

2018 Year 02 Month 05 Day

Date of IRB


Anticipated trial start date

2018 Year 03 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

2018 Year 02 Month 06 Day

Last modified on

2018 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035529


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name