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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027708
Receipt No. R000031742
Scientific Title Prospective intervention trial of CAD/CAM complete denture
Date of disclosure of the study information 2017/06/12
Last modified on 2017/06/09

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Basic information
Public title Prospective intervention trial of CAD/CAM complete denture
Acronym Prospective intervention trial of CAD/CAM complete denture
Scientific Title Prospective intervention trial of CAD/CAM complete denture
Scientific Title:Acronym Prospective intervention trial of CAD/CAM complete denture
Region
Japan

Condition
Condition Patients who have totally edentulous upper and lower jaw
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of the CAD/CAM denture, revealing the potential for clinical application.
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 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 CAD/CAM complete denture prepared
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have totally edentulous upper and lower jaw.
All patients received thorough explanations and had to complete a written informed consent form prior to being enrolled in the trial.

Key exclusion criteria Patients who have deficits in the bones of the maxilla and mandible.
Patients who are considered to have difficulties in dental treatment due to general health problems.
Patients who have difficulties in communicating on treatment due to reasons such as dementia.
Patients who have significant difficulties visiting hospital for physical, mental and social reasons.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Kanazawa
Organization Tokyo Medical and Dental University
Division name Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences
Zip code
Address Tokyo Medical and Dental University, Tushima, Bunkyo-ku, Tokyo 113-8549, Japan
TEL 0358035563
Email m.kanazawa.gerd@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Kanazawa
Organization Tokyo Medical and Dental University
Division name Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences
Zip code
Address Tokyo Medical and Dental University, Tushima, Bunkyo-ku, Tokyo 113-8549, Japan
TEL 0358035563
Homepage URL
Email m.kanazawa.gerd@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 06 Month 12 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 09 Day
Last modified on
2017 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031742

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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