UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of newly developed complete CAD/CAM dentures in fully edentulous patients.
Title of the study (Brief title)	Clinical evaluation of newly developed complete CAD/CAM dentures.
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 newly developed CAD/CAM dentures in fully edentulous patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Oral health related Quality of Life at 1 month after completion of the denture adjustment.
Key secondary outcomes	1) Fitting and stability of denture 2 )Onset of the allergic symptom 3 )Fracture of denture

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
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 CAD/CAM denture/Conventional complete denture (Subjects receive Conventional complete denture and outcome evaluation at first. Subjects receive Complete CAD/CAM denture subsequently.)
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 use Conventional complete denture without complications. 2)Patient willing and able to provide informed consent.
Key exclusion criteria	1) Patients who are difficult to provide informed consent, for example dementia. 2) Allergy of acrylic resin 3) Patients who difficult to follow up. 4) Other patients who are judged by physician as being unsuitable
Target sample size	7

Research contact person
Name of lead principal investigator	Takuo Kuboki
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
Division name	Department of Oral Rehabilitation and Regenerative Medicine
Address	2-5-1, Shikata-cho,Kita-ku, Okayama, Japan
TEL	+81-86-235-6682
Email	kuboki@md.okayama-u.ac.jp

Public contact
Name of contact person	Aya Ono
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Jap
Division name	Department of Oral Rehabilitation and Regenerative Medicine
Address	2-5-1, Shikata-cho,Kita-ku, Okayama, Japan
TEL	+81-86-235-6682
Homepage URL
Email	a-kimura@md.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	Mitsui Chemicals, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 10 Month 30 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 09 Month 15 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 21 Day
Last modified on	2016 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022479