UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044714 |
|---|---|
| Receipt number | R000051065 |
| Scientific Title | Can a maxillary implant overdenture work with two implants? |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/06/30 14:56:15 |
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Basic information
Public title
Can a maxillary implant overdenture work with two implants?
Acronym
Prospective clinical trial of maxillary 2-IOD
Scientific Title
Can a maxillary implant overdenture work with two implants?
Scientific Title:Acronym
Prospective clinical trial of maxillary 2-IOD
Region
| Japan |
Condition
Condition
edentulous
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a prospective clinical study on 20 edentulous maxillary patients with 2-IOD using two implants and locator attachment as a maintenance source, and to clarify implant survival rate, peri-implant bone resorption, implant stability index, patient satisfaction, oral-related QoL and objective masticatory ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Implant Survival Rate
Key secondary outcomes
Peri-implant bone resorption
Implant Stability Index
Patient Satisfaction
Oral-related QoL
Objective masticatory ability
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
2 - Implant Overdenture
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Upper and lower jaw edentulou
Able to answer the self-administered questionnaire
General condition that allows implant surgery
Maxillary crest: height (deepest part of the palate to the top of the crest): 10 mm or more, width 50 mm or more, length: 40 mm or more
Key exclusion criteria
Poorly controlled general condition
History of BPS medication
History of chemotherapy or radiation therapy to the head and neck region
Heavy smoker
Infectious disease
Psychiatric disorders
Temporomandibular joint disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kanazawa |
Organization
Graduate School of Medical and Dental Sciences
Tokyo Medical and Dental University (TMDU)
Division name
Digital Dentistry
Zip code
1138549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan
TEL
03-5803-5379
m.kanazawa.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Iwaki |
Organization
Graduate School of Medical and Dental Sciences Tokyo Medical and Dental University (TMDU)
Division name
Digital Dentistry
Zip code
1138549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan
TEL
03-5803-5379
Homepage URL
m.iwaki.gerd@tmd.ac.jp
Sponsor or person
Institute
Digital Dentistry, Graduate School of Medical and Dental Sciences Tokyo Medical and Dental University (TMDU)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medical and Dental Sciences Tokyo Medical and Dental University (TMDU)
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan
Tel
03-5803-5379
m.kanazawa.gerd@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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 06 | Month | 30 | Day |
Last modified on
| 2021 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051065
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
