UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of the accuracy of fixed prosthetic apliance were manufactured by using the Arcus Digma II
Title of the study (Brief title)	Verification of the accuracy of fixed prosthetic apliance were manufactured by using the Arcus Digma II
Region	Japan

Condition
Condition	caries
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of the accuracy of CAD/CAM fixed prosthetic apliance between using jaw movement measuring device or not.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The adjustment amount made in subjects' mouth to compare investigated using three-dimensional scanner.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Prosthodontic appliance using a semi-adjustment articulator equipment (CAD / CAM crown)
Interventions/Control_2	Prosthodontic appliance using Digma module (CAD / CAM crown)
Interventions/Control_3	Prosthodontic appliance using a mean value articulator (CAD / CAM crowns)
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	Patients of Tokushima University Hospital Dental clinic They have personality normal occlusion
Key exclusion criteria	Temporomandibular dysfunction Systemic illness Predictable bad tooth The dental caries over a number of teeth Many teeth missing
Target sample size	60

Research contact person
Name of lead principal investigator	Kazuo Okura
Organization	Tokushima university (Graduate School)
Division name	Department of Stomatognathic Function and Occlusal Reconstruction
Address	3-18-15, Kuramoto-cho, Tokushima, Tokushima
TEL	0886-33-7350
Email	okura.kazuo@tokushima-u.ac.jp

Public contact
Name of contact person	Yoshitaka Suzuki
Organization	Tokushima university (Graduate School)
Division name	Department of Stomatognathic Function and Occlusal Reconstruction
Address	3-18-15, Kuramoto-cho, Tokushima, Tokushima
TEL	0886-33-7350
Homepage URL
Email	yosuzuki@tokushima-u.ac.jp

Sponsor
Institute	Tokushima university (Graduate School) Department of Stomatognathic Function and Occlusal Reconstruction
Institute
Department

Funding Source
Organization	Tokushima university (Graduate School)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	徳島大学病院（徳島県）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 28 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 07 Month 17 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

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

Management information
Registered date	2015 Year 07 Month 28 Day
Last modified on	2019 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021323