UMIN-CTR Clinical Trial

Basic information
Public title	A prospective clinical study of complete dentures fabricated CAD/CAM using milling custom disc.
Acronym	A prospective clinical study of complete dentures fabricated CAD/CAM using milling custom disc.
Scientific Title	A prospective clinical study of complete dentures fabricated CAD/CAM using milling custom disc.
Scientific Title:Acronym	A prospective clinical study of complete dentures fabricated CAD/CAM using milling custom disc.
Region	Japan

Condition
Condition	missing teeth
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of manufacturing time and cost of complete dentures fabricated CAD/CAM using milling custom disc with conventional methods.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient satisfaction
Key secondary outcomes

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	Maneuver
Interventions/Control_1	single-group study
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	Those who wish to make upper and lower dentures in the Tokyo Medical and Dental University (the field of dentistry for the elderly) and who have received sufficient explanation to participate in this study among patients who do not fall under any of the exclusion criteria, and have obtained written consent of the patient himself/herself with sufficient understanding.
Key exclusion criteria	Those who have defects in the upper and lower jaw bones, those who have problems with their whole body health and who think dental treatment is difficult, those who have difficulty communicating with treatment due to dementia, etc., and those who experience significant difficulties in coming to the hospital for physical, mental, or social reasons.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Syunsuke Middle name Last name Minakuchi
Organization	TOKYO MEDICAL and DENTAL UNIVERSITY
Division name	Gerodontology and Oral Rehabilitation
Zip code	1138519
Address	1-5-45,yushima,bunkyo-ku,tokyo
TEL	03-5803-5582
Email	s.minakuchi.gerd@tmd.ac.jp

Public contact
Name of contact person	1st name Manabu Middle name Last name Kanazawa
Organization	TOKYO MEDICAL and DENTAL UNIVERSITY
Division name	Gerodontology and Oral Rehabilitation
Zip code	1138519
Address	1-5-45,yushima,bunkyo-ku,tokyo
TEL	03-5803-4645
Homepage URL
Email	m.kanazawa.gerd@tmd.ac.jp

Sponsor
Institute	TOKYO MEDICAL and DENTAL UNIVERSITY
Institute
Department

Funding Source
Organization	Self-procurement
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	TOKYO MEDICAL and DENTAL UNIVERSITY
Address	1-5-45,yushima,bunkyo-ku,tokyo
Tel	0358035583
Email	r.otake.gerd@tmd.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	2020 Year 10 Month 30 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	Preinitiation
Date of protocol fixation	2020 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date	2021 Year 01 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 13 Day
Last modified on	2020 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048044