UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027104 |
|---|---|
| Receipt number | R000031064 |
| Scientific Title | Assessment for Stabilizing Effect of Removable Partial Denture on Remaining Teeth with Increased Mobility:Prospective Cohort Study |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2023/10/29 09:10:40 |
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Basic information
Public title
Assessment for Stabilizing Effect of Removable Partial Denture on Remaining Teeth with Increased Mobility:Prospective Cohort Study
Acronym
Assessment for Stabilizing Effect of Removable Partial Denture on Remaining Teeth with Increased Mobility
Scientific Title
Assessment for Stabilizing Effect of Removable Partial Denture on Remaining Teeth with Increased Mobility:Prospective Cohort Study
Scientific Title:Acronym
Assessment for Stabilizing Effect of Removable Partial Denture on Remaining Teeth with Increased Mobility
Region
| Japan |
Condition
Condition
Missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment for Secondary Splinting Effect of Removable Partial Denture on Remaining Teeth with Increased Mobility
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pocket Probing Depth
Bleeding on Probing
Tooth Mobility
Clinical Attachment Level
Occlusal Pressure
Subjective Evaluation of Subjects using Questionnaires
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Existence of Remaining Teeth with Increased Mobility
Partially Edentulous Patients Needing Treatment with Removable Partial Dentures
Key exclusion criteria
Acute symptoms of oral and craniofacial diseases
Contraction of infectious disease or systemic disease(leukemia,HIV, etc.)
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Junichiro |
| Middle name | |
| Last name | Wada |
Organization
Tokyo Medical and Dental University
Division name
Removable Partial Prosthodontics,Graduate School of Medical and Dental Sciences
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5515
wadajun.rpro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | Wada |
Organization
Tokyo Medical and Dental University
Division name
Removable Partial Prosthodontics,Graduate School of Medical and Dental Sciences
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5515
Homepage URL
wadajun.rpro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Dental and Medital 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
Tokyo Dental and Medital University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, #113-8549, JAPAN
Tel
03-5803-5515
wadajun.rpro@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
| 2017 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/detail/um?trial_id=UMIN000027104
Publication of results
Unpublished
Result
URL related to results and publications
results are not available
Number of participants that the trial has enrolled
27
Results
The results are still not available to be reported.
Results date posted
| 2023 | Year | 10 | Month | 29 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to the COVID-19 pandemic, the total number of participants is lower than expected when starting this study. Thus, we're now trying to use several statistical methods to care about confounders.
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
| 2017 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 07 | 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 | 24 | Day |
Last modified on
| 2023 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031064
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
