UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022769 |
|---|---|
| Receipt number | R000026224 |
| Scientific Title | prospective intervention trial of IARPD with short implants |
| Date of disclosure of the study information | 2016/06/20 |
| Last modified on | 2023/02/16 19:25:18 |
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Basic information
Public title
prospective intervention trial of IARPD with short implants
Acronym
prospective intervention trial of IARPD with short implants
Scientific Title
prospective intervention trial of IARPD with short implants
Scientific Title:Acronym
prospective intervention trial of IARPD with short implants
Region
| Japan |
Condition
Condition
patients lower jaw on both sides free end deficit
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the partial denture with short implants , revealing the potential for clinical application
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The survival rate and the success rate of the implant and IARPD
Key secondary outcomes
patient-reported outcomes , chewing ability , food intake status , nutritional status
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 | Maneuver |
Interventions/Control_1
Short implant placement and IARPD 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
| 45 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Lower jaw free end deficient patients (Kennedy classification 1 , the fifth of both sides missing ) wearing the appropriate partial denture person .
Patients who implant embedded get surgery is received .
Deficient state of the upper jaw does not matter .
Key exclusion criteria
Temporomandibular joint disease , xerostomia , infection disease, oral movement disorder , dementia , a person who has a mental illness . Those who do not receive the implant implantation surgery .
Target sample size
40
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 of Medical and Dental Sciences, Digital Dentistry
Zip code
113-8549
Address
1-5-45, Yushima, Bunko-ku, Tokyo, Japan
TEL
03-5803-5379
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 of Medical and Dental Sciences, Digital Dentistry
Zip code
113-8549
Address
1-5-45, Yushima, Bunko-ku, Tokyo, Japan
TEL
03-5803-5379
Homepage URL
m.kanazawa.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Showa University Dental Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dental Research Ethics Committee of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunko-ku, Tokyo, Japan
Tel
0358035404
d-hyoka.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附属病院（東京都）、昭和大学歯科病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 20 | 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
30
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
| 2016 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026224
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/11/24 | 実施計画書修正版２.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
