UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039233 |
|---|---|
| Receipt number | R000043733 |
| Scientific Title | Impact of diabetes mellitus on tooth survival of removable partial denture abutment |
| Date of disclosure of the study information | 2020/01/31 |
| Last modified on | 2023/01/24 16:24:57 |
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Basic information
Public title
Impact of diabetes mellitus on tooth survival of removable partial denture abutment
Acronym
Impact of DM on survival of RPD abutment
Scientific Title
Impact of diabetes mellitus on tooth survival of removable partial denture abutment
Scientific Title:Acronym
Partially Edentulous Diabetic Investigation (PEDI study)
Region
| Japan |
Condition
Condition
partially edentulous dentition
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of removable partial denture (RPD) placement on tooth survival of RPD abutment in patients with diabetes mellitus (DM) compared with in patients without DM.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival rate of RPD abutment tooth
Key secondary outcomes
Alveolar bone density around abutment tooth
Tooth mobility
Probing pocket depth
Crown-root ratio
Clinical attachment level
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
Condition of DM can be detectable with blood test
Need for recovery of missing teeth with RPD
Key exclusion criteria
Acute symptoms of oral and craniofacial diseases
Difficulty for using RPD
Significant malalignment of teeth
No agreement for regular maintenance
Contraction of infectious disease or systemic disease (leukemia, HIV, etc.)
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Fueki |
Organization
Tokyo Medical and Dental University (TMDU)
Division name
Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences
Zip code
113-8510
Address
Yushima, 1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-5514
kunfu.rpro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Fueki |
Organization
Tokyo Medical and Dental University (TMDU)
Division name
Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences
Zip code
113-8510
Address
Yushima, 1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-5514
Homepage URL
kunfu.rpro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University (TMDU)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science, and Technology of Japan
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
Tokyo Medical and Dental University (TMDU)
Address
Yushima, 1-5-45, Bunkyo-ku, Tokyo
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
| 2020 | Year | 01 | Month | 31 | 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
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After grouping of subjects based on with/without diabetes mellitus (DM), removable partial dentures are deliverd for them. Then, condition of abutment teeth will be evaluated for 5 years after RPD delivery.
Management information
Registered date
| 2020 | Year | 01 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043733
| Research Plan | |
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| 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 |
