UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037076 |
|---|---|
| Receipt number | R000042250 |
| Scientific Title | Effects of Prosthodontic treatment on default mode network by dentures in patients with distal extension missing tooth of Eichner B2 and B3 |
| Date of disclosure of the study information | 2019/06/17 |
| Last modified on | 2020/06/15 12:26:14 |
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Basic information
Public title
Effects of Prosthodontic treatment on default mode network by dentures in patients with distal extension missing tooth of Eichner B2 and B3
Acronym
Effects of Prosthodontic treatment on default mode network by dentures in patients with distal extension missing tooth of Eichner B2 and B3
Scientific Title
Effects of Prosthodontic treatment on default mode network by dentures in patients with distal extension missing tooth of Eichner B2 and B3
Scientific Title:Acronym
Effects of Prosthodontic treatment on default mode network by dentures in patients with distal extension missing tooth of Eichner B2 and B3
Region
| Japan |
Condition
Condition
patients with distal extension missig tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to analyze the resting DMN of patients with missing molars and compare with healthy dentulous subjects to clarify the effect of tooth loss on the brain. In addition, analyze the effect of prosthetic treatment by denture on DMN during rest.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of default mode network of edentulous patients by wearing dentures
Key secondary outcomes
Change of default mode network by missing tooth
Correlation between jaw and neck muscle activity during chewing and default mode network
Correlation between increase in cerebral blood flow during chewing and default mode network
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Wearing partial dentures
Interventions/Control_2
no treatment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with distal extension missing treatment by partial dentures
Key exclusion criteria
Patients with magnetic material such as clips in the head and neck
Patients with assistance in eating
Claustrophobia and Nyctophobia
A left handed person
A psychiatric patient
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ishii |
Organization
Nihon universuty School of dentistry at Matsudo
Division name
Department of removable prosthodontics
Zip code
271-8587
Address
Sakaecho nishi 2-870-1, Matsudo, Chiba, Japan
TEL
047-360-9387
ishii.tomohiro@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ishii |
Organization
Nihon universuty School of dentistry at Matsudo
Division name
Department of removable prosthodontics
Zip code
271-8587
Address
Sakaecho nishi 2-870-1, Matsudo, Chiba, Japan
TEL
047-360-9387
Homepage URL
ishii.tomohiro@nihon-u.ac.jp
Sponsor or person
Institute
Nihon universuty School of dentistry at Matsudo
Institute
Department
Personal name
Funding Source
Organization
Nihon universuty School of dentistry at Matsudo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon universuty School of dentistry at Matsudo
Address
Sakaecho nishi 2-870-1, Matsudo, Chiba, Japan
Tel
047-360-9387
ishii.tomohiro@nihon-u.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
日本大学松戸歯学部付属病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 15 | Day |
Last modified on
| 2020 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042250
| 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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