UMIN-CTR Clinical Trial

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
Email	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
Email	ishii.tomohiro@nihon-u.ac.jp

Sponsor
Institute	Nihon universuty School of dentistry at Matsudo
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042250