UMIN-CTR Clinical Trial

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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029797