UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025916
Receipt number R000029797
Scientific Title Development of full digital new technique to reflect the form of provisional restorations adjusted in the oral environment and shape of gingiva to the final restoration of the dental implants.
Date of disclosure of the study information 2017/04/01
Last modified on 2019/08/08 16:37:12

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Basic information

Public title

Development of full digital new technique to reflect the form of provisional restorations adjusted in the oral environment and shape of gingiva to the final restoration of the dental implants.

Acronym

Complete reproduction of the form of provisional restorations using full digital new technique.

Scientific Title

Development of full digital new technique to reflect the form of provisional restorations adjusted in the oral environment and shape of gingiva to the final restoration of the dental implants.

Scientific Title:Acronym

Complete reproduction of the form of provisional restorations using full digital new technique.

Region

Japan


Condition

Condition

Missing teeth

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess safety, feasibility, and efficacy of full digital new technique in patients who receive dental implant treatment

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Three-dimensional differences of the form of two final restorations, which are fabricated using different methods compared with provisional restoration

Key secondary outcomes

Conditions of fitness and occlusal contact


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

Fabrication of final restoration of the dental implants by taking optical impression using TRIOS2

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients who receive dental implant treatment to their bounded saddle or free-end saddle missing teeth
2.Patients who receive dental implant treatment using FINESIA Implant System, manufactured by KYOCERA Medical Corporation
3.Patient who shows his/her will to participate in this study after obtaining informed consent through the substantial explanation on this investigation

Key exclusion criteria

1.Patients who have difficulties to show their will, such as patients with dementia
2.Patients who have plan of hospital transfer before installation of final restoration
3.Patients who are judged by investigators as being unsuitable because of other factors

Target sample size

6


Research contact person

Name of lead principal investigator

1st name Takuo
Middle name
Last name Kuboki

Organization

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan

Division name

Department of Oral Rehabilitation and Regenerative Medicine

Zip code

700-8525

Address

2-5-1,Shikata-cho,Kita-ku, Okayama, Japan

TEL

086-235-6682

Email

kuboki@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name Takuya
Middle name
Last name Mino

Organization

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama

Division name

Department of Oral Rehabilitation and Regenerative Medicine

Zip code

700-8525

Address

2-5-1,Shikata-cho,Kita-ku, Okayama, Japan

TEL

086-235-6682

Homepage URL


Email

gmd20107@s.okayama-u.ac.jp


Sponsor or person

Institute

Department of Oral Rehabilitation and Regenerative Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan

Institute

Department

Personal name



Funding Source

Organization

KYOCERA Corporation

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

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee

Address

2-5-1,Shikata-cho,Kita-ku, Okayama, Japan

Tel

086-235-6938

Email

mae6605@adm.okayama-u.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



Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 01 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

6

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

2017 Year 03 Month 21 Day

Date of IRB

2017 Year 03 Month 22 Day

Anticipated trial start date

2017 Year 04 Month 01 Day

Last follow-up date

2019 Year 03 Month 29 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 01 Month 31 Day

Last modified on

2019 Year 08 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029797


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name