UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009889 |
|---|---|
| Receipt number | R000011588 |
| Scientific Title | Immediate loading of two magnet retained implant overdenture in edentulous patients: A randomized controlled clinical trial. |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2013/09/04 17:35:53 |
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Basic information
Public title
Immediate loading of two magnet retained implant overdenture in edentulous patients: A randomized controlled clinical trial.
Acronym
Immediate loading of two-implant overdenture: A randomized controlled clinical trial.
Scientific Title
Immediate loading of two magnet retained implant overdenture in edentulous patients: A randomized controlled clinical trial.
Scientific Title:Acronym
Immediate loading of two-implant overdenture: A randomized controlled clinical trial.
Region
| Japan |
Condition
Condition
Completely mandibular edentulous arch
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of immediate loading implant overdentures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral Health-related Quality of life
Key secondary outcomes
Patient satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Immediate loading of implant overdenture
Interventions/Control_2
Conventional loading of implant overdenture
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
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Minakuchi |
Organization
Tokyo Medical and Dental University
Division name
Graduate school, Gerodontology and Oral Rehabilitation
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5582
s.minakuchi.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Minakuchi |
Organization
Tokyo Medical and Dental University
Division name
Graduate school, Gerodontology and Oral Rehabilitation
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5582
Homepage URL
s.minakuchi.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | 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
| 2013 | Year | 01 | Month | 28 | Day |
Last modified on
| 2013 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011588
