UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective multi-institutional joint study on masticatory ability
Acronym	Retrospective multi-institutional joint study on masticatory ability
Scientific Title	Retrospective multi-institutional joint study on masticatory ability
Scientific Title:Acronym	Retrospective multi-institutional joint study on masticatory ability
Region	Japan

Condition
Condition	none
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Dysphagia could often be observed in elderly population. Considering the achievement of daily nutrition, objective evaluation of masticatory function would be of importance. Distinguishing the foodstuffs which could be fully masticated would be an important information on improving QoL of the elderly. This study aimed to evaluate digital images of food particles in masticated bolus, which were already taken in our university or other cooperating universities, to establish the data to support the availability of our masticatory efficiency evaluation system.
Basic objectives2	Others
Basic objectives -Others	none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	masticatory efficiency indexes (HI and SI)
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Data which were already collected in cooperative institutes
Key exclusion criteria	none
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shogo Minagi
Organization	Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525
TEL	086-235-6685
Email	minagi@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shogo Minagi
Organization	Okayama University
Division name	Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525
TEL	086-235-6685
Homepage URL
Email	minagi@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Okayama 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
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	2017 Year 02 Month 10 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	2017 Year 01 Month 20 Day
Date of IRB	2017 Year 01 Month 20 Day
Anticipated trial start date	2017 Year 02 Month 20 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Collect the digital images of food particles and analyze them.

Management information
Registered date	2017 Year 02 Month 03 Day
Last modified on	2020 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028745