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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024902
Receipt No. R000028653
Scientific Title Influence of use of home reliner on alveolar ridge
Date of disclosure of the study information 2016/11/18
Last modified on 2017/11/21

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Basic information
Public title Influence of use of home reliner on alveolar ridge
Acronym Influence of use of home reliner on alveolar ridge
Scientific Title Influence of use of home reliner on alveolar ridge
Scientific Title:Acronym Influence of use of home reliner on alveolar ridge
Region
Japan

Condition
Condition missing teeth
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the influence of the use of home reliner on the blood flow of the alveolar ridge
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of blood flow
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Measurement of blood flow during normal complete denture use
Interventions/Control_2 Measurement of blood flow during use of complete denture with home reliner
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
100 years-old >=
Gender Male and Female
Key inclusion criteria n the past complete denture was made and now undergoing maintenance at tokyo Medical and Dental University.
Key exclusion criteria Persons who are considered to have difficulties in dental treatment due to general health condition.
Those who have difficulty in communicating.
Those who have remarkable difficulties in visiting hospital
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihisa Akiba
Organization Tokyo Medical and Dental University
Division name Gerodontology and Oral Rehabilitation
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5585
Email n.akiba.ore@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihisa Akiba
Organization Tokyo Medical and Dental University
Division name Gerodontology and Oral Rehabilitation
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5585
Homepage URL
Email n.akiba.ore@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Self funding
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
Address
Tel
Email

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
2016 Year 11 Month 18 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 Terminated
Date of protocol fixation
2016 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 01 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
2016 Year 11 Month 18 Day
Last modified on
2017 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028653

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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