UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019260 |
|---|---|
| Receipt number | R000022252 |
| Scientific Title | Measurements of tongue movement during mastication |
| Date of disclosure of the study information | 2015/10/07 |
| Last modified on | 2017/10/08 09:21:00 |
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Basic information
Public title
Measurements of tongue movement during mastication
Acronym
Measurements of tongue movement during mastication
Scientific Title
Measurements of tongue movement during mastication
Scientific Title:Acronym
Measurements of tongue movement during mastication
Region
| Japan |
Condition
Condition
Dysphasia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence by bolus size and food consistency on tongue movement during mastication.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sagittal tongue movement,tongue pressure,jaw movement
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Sagittal tongue movements are recorded with video fluorography in lateral projection. For recordings, small lead discs are used as radiopaque markers to quantify the tongue surface. Also, tongue pressures are measured using a sensor sheet system (Swallow Scan, Nitta Co., Osaka, Japan) with five measurement points to predict frontal tongue shift. In addition, the jaw movement is measured using a marker-tracking system (V120: Duo, SPICE Co., Tokyo, Japan). These three devices are synchronized and tongue movement according to mastication process is observed over time.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The volunteers are healthy adults
Key exclusion criteria
Patient without ability to consent
Patient without dysphasia
Person who is determined to be unable to make the secure measured by measure
Person who during pregnancy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kan Nagao |
Organization
The University of Tokushima
Division name
Department of Oral & Maxillofacial Prosthodontics and Oral Implamtology
Zip code
Address
3-18-15 Kuramoto, Tokushima
TEL
088-633-7347
kan@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Fujimoto |
Organization
The University of Tokushima
Division name
Department of Oral & Maxillofacial Prosthodontics and Oral Implamtology
Zip code
Address
3-18-15 Kuramoto, Tokushima
TEL
088-633-7347
Homepage URL
c301451014@tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
The University of Tokushima
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
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
| 2015 | Year | 10 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 07 | 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
| 2015 | Year | 10 | Month | 07 | Day |
Last modified on
| 2017 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022252
