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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009213
Receipt No. R000010814
Scientific Title Clinical evaluation of mini dental implans with removable prosthodontics
Date of disclosure of the study information 2012/10/30
Last modified on 2018/10/15

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Basic information
Public title Clinical evaluation of mini dental implans with removable prosthodontics
Acronym Clinical evaluation of mini dental implans
Scientific Title Clinical evaluation of mini dental implans with removable prosthodontics
Scientific Title:Acronym Clinical evaluation of mini dental implans
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of the fracture risk of mini dental implants
Evaluation of the clinical effect of mini dental implants
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Implant fracture
Denture fracture
Masticatory function by questionnaire
VAS of 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
Device,equipment
Interventions/Control_1 Mini dental implants
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Edentulous mandibular
Sufficient bone volume in the anterior mandible to receive mini dental implants
Dissatisfied their existing conventional mandibular denture
Key exclusion criteria Physical and mental disabilities which interfere with the maintenance of implants
Severe clenching habits
Current smokers
Those who abuse alcohol or drugs
On long-term thrapy with steroids, immunosuppressants or bisphosphonates
Diabetic patients
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Wakabayashi
Organization Tokyo Medical and Dental Univeristy
Division name Removable Prosthodontics
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Medical and Dental University
Division name Removable Prosthodontics
Zip code
Address
TEL
Homepage URL
Email takepro1@tmd.ac.jp

Sponsor
Institute Removable Prosthodontics, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization GC Corporation
Organization
Division
Category of Funding Organization Profit organization
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
2012 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 Completed
Date of protocol fixation
2012 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 30 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
2012 Year 10 Month 29 Day
Last modified on
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010814

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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