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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026972
Receipt No. R000030915
Scientific Title Functional evaluation of mini implants overdenture
Date of disclosure of the study information 2017/04/17
Last modified on 2019/04/17

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Basic information
Public title Functional evaluation of mini implants overdenture
Acronym Evaluation of mini implants overdenture
Scientific Title Functional evaluation of mini implants overdenture
Scientific Title:Acronym Evaluation of mini implants overdenture
Region
Japan

Condition
Condition Completely mandibular edentulous arch
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the function of mandibular mini implants overdentures
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 mini implants overdentures
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Completely mandibular edentulous arch
Having sufficient volume and quality to receive two implant
Can walking alone, and come to hospital
Key exclusion criteria Having osteoporosis
Having a history of head and neck radiation
Having heavy systemic disorders
Heavy smokers
Having infections
Undergoing radiation therapy and chemotherapy
Target sample size 7

Research contact person
Name of lead principal investigator
1st name Manabu
Middle name
Last name Kanazawa
Organization Tokyo Medical and Dental University
Division name Graduate school, Gerodontology and Oral Rehabilitation
Zip code 113-8510
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5563
Email m.kanazawa.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 Graduate school, Gerodontology and Oral Rehabilitation
Zip code 113-8510
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5563
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 Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Medical Research Institute Tokyo Medical and Dental University
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel 03-5803-4523
Email mri.adm@cmn.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 東京医科歯科大学歯学部付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 17 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 2
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 No longer recruiting
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
2014 Year 09 Month 22 Day
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2020 Year 03 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
2017 Year 04 Month 12 Day
Last modified on
2019 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030915

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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