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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039233
Receipt No. 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 2020/01/22

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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
Email 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
Email kunfu.rpro@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University (TMDU)
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
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
2020 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043733

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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