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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027104
Receipt No. 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 2019/04/27

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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 Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Placement of Removable Partial Denture for Patients with Remaining Teeth Increasing Mobility
Interventions/Control_2 Placement of Removable Partial Denture for Patients with Normal Remaining Teeth
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 70

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
Email 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
Email wadajun.rpro@tmd.ac.jp

Sponsor
Institute Tokyo Dental and Medital University
Institute
Department

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
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
2017 Year 07 Month 01 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
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
2020 Year 03 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
2019 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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