UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032795 |
|---|---|
| Receipt number | R000037411 |
| Scientific Title | Establishment of a treatment protocol of implant-assisted removable partial denture for partially edentulous arch |
| Date of disclosure of the study information | 2018/06/04 |
| Last modified on | 2018/05/30 23:42:08 |
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Basic information
Public title
Establishment of a treatment protocol of implant-assisted removable partial denture for partially edentulous arch
Acronym
Establishment of a treatment protocol of implant-assisted removable partial denture
Scientific Title
Establishment of a treatment protocol of implant-assisted removable partial denture for partially edentulous arch
Scientific Title:Acronym
Establishment of a treatment protocol of implant-assisted removable partial denture
Region
| Japan |
Condition
Condition
Partially edentulous arch
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a treatment protocol of implant-assisted removable partial denture for partially edentulous arch
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral-health related quality of life (score of oral health impact profile)
Key secondary outcomes
Survival rate, success rate (implant, RPD)
Status of abutment teeth (probing pocket depth, mobility, bleeding on probing)
Chewing ability
Marginal bone loss
Status of RPD / score of McGill Denture Satisfaction
Dental implant length
Attachment
RPD design
Base
Study type
Interventional
Study design
Basic design
expanded access
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 |
Interventions/Control_1
Dental implant placement for support and retention of removable partial denture
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
Partially edentulous patients (e.g. Eichner index B3/B4/C1/C2 or Kennedy Class 1/2) wearing proper removable partial dentures
Operable patients for dental implant placement
Patients who gave written informed consent in first-person
Key exclusion criteria
Orofacial acute symptoms
Orofacial pain
Moter disability/disorders in orofacial region
Disability to answer self-completed questionnaires
Psychiatric disorders
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuka Abe |
Organization
Showa University
Division name
Department of Prosthodontics
Zip code
Address
2-1-1, Kitasenzoku, Ota-ku, Tokyo
TEL
03-3787-1151
abeyuka@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Abe |
Organization
Showa University
Division name
Department of Prosthodontics
Zip code
Address
2-1-1, Kitasenzoku, Ota-ku, Tokyo
TEL
03-3787-1151
Homepage URL
abeyuka@dent.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical and Dental University
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | 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
| 2018 | Year | 05 | Month | 30 | Day |
Last modified on
| 2018 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037411
| 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 |
