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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032354
Receipt No. R000036899
Scientific Title The survey of oral function after treatment for oral tumors and oral mucosal diseases
Date of disclosure of the study information 2018/04/24
Last modified on 2019/04/28

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Basic information
Public title The survey of oral function after treatment for oral tumors and oral mucosal diseases
Acronym The survey of oral function after treatment for oral tumors and oral mucosal diseases
Scientific Title The survey of oral function after treatment for oral tumors and oral mucosal diseases
Scientific Title:Acronym The survey of oral function after treatment for oral tumors and oral mucosal diseases
Region
Japan

Condition
Condition oral tumors and oral mucosal diseases
Classification by specialty
Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To study the therapeutic strategy to keep oral function as much as possible.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 3)Masticatory function test (before and after surgery)
Bite force
Gummy jelly
Chewing gum
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 30 minutes/test, before and after surgery.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients after treating for oral tumors and oral mucosal diseases in Tokyo Medical and Dental University Hospital.
Key exclusion criteria cerebral infarction, sysystemic nervous system disease
Target sample size 420

Research contact person
Name of lead principal investigator
1st name Yasuyuki
Middle name
Last name Michi
Organization Tokyo Medical and Dental University
Division name Department of Oral and Maxillofacial Surgery
Zip code 113-8549
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5742
Email y-mic.mfs@tmd.ac.jp

Public contact
Name of contact person
1st name Yasuyuki
Middle name
Last name Michi
Organization Tokyo Medical and Dental University
Division name Department of Oral and Maxillofacial Surgery
Zip code 113-8549
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5742
Homepage URL
Email y-mic.mfs@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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 Tokyo Medical and Dental University
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel 03-5803-4724
Email info.bec@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
2018 Year 04 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 04 Month 01 Day
Date of IRB
2012 Year 04 Month 01 Day
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2025 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
2018 Year 04 Month 24 Day
Last modified on
2019 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036899

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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