UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial
Title of the study (Brief title)	The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial
Region	Japan

Condition
Condition	Edentulous Patients
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of porcelain teeth in complete dentures
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Oral health related Quality of Life (OHIP-EDENT) (3months after insertion of complete dentures)
Key secondary outcomes	satisfaction masticatory performance occlusal force

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	porcelain teeth
Interventions/Control_2	hard resin teeth
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	Patients with complete dentures
Key exclusion criteria	severe alveolar rigde resorption, Maxillofacial Prothetics, severe xerostomia
Target sample size	52

Research contact person
Name of lead principal investigator	Atsuro Yokoyama
Organization	Graduate school of Dental Medicine,Hokkaido University
Division name	Department of Oral functional Prothodontics
Address	Nishi-7, Kita-13, Kita-Ku, Sapporo, Japan
TEL	011-706-4270
Email	yokoyama@den.hokudai.ac.jp

Public contact
Name of contact person	Toshifumi Nogawa
Organization	Hokkaido University Hospital
Division name	Clinical research and medical innovation center
Address	Nishi-5, Kita-14, Kita-Ku, Sapporo, Japan
TEL	011-706-7935
Homepage URL
Email	t.nogawa@den.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Shofu 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	北海道大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 06 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 02 Month 05 Day
Anticipated trial start date	2018 Year 03 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	2018 Year 02 Month 06 Day
Last modified on	2018 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035529