UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020786 |
|---|---|
| Receipt number | R000023989 |
| Scientific Title | The effect of jaw position on body balance during walking |
| Date of disclosure of the study information | 2016/01/29 |
| Last modified on | 2016/01/29 18:05:40 |
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Basic information
Public title
The effect of jaw position on body balance during walking
Acronym
The effect of jaw position on body balance
Scientific Title
The effect of jaw position on body balance during walking
Scientific Title:Acronym
The effect of jaw position on body balance
Region
| Japan |
Condition
Condition
Healthy dentulous and edentulous wearing complete dentures
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Body equilibrium is considered to have been adjusted by a variety of factors such as sensory organs like tactile, visual and sense of balance. But the role of the occlusion area is not yet clear. The purpose of this study is reveal the effect of jaw position on body balance during walking as a daily operation.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In dentulous, three jaw positions are set by sprints; intercuspal position, centric relation, protrusive position. Edentulous are grouped in the presence or absence of dentures. Respectively, walking speed, stride length, the acceleration and the angular velocity of the three axes of the head and chin are measured.
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Dentulous with splint attached or edentulous with/without dentures.
Intervention period only at the time of measurement.
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
Healthy dentulous and edentulous wearing complete dentures.
Key exclusion criteria
Those who has a temporomandibular joint disease, oral dysfunction, those with dementia and mental illness, those with diseases of nervous system and orthopedic, those who is difficult in independence walking without a walking aid such as a cane, those within the last 6 months who have a history of lower extremity fractures, those with a balance dysfunction.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minakuchi Shunsuke |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5582
s.minakuchi.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Okubo Mai |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5586
Homepage URL
m.okubo.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University, Gerodontology and Oral Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 01 | Month | 29 | 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
| 2016 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 29 | 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
| 2016 | Year | 01 | Month | 28 | Day |
Last modified on
| 2016 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023989
