UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020786
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email m.okubo.gerd@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University, Gerodontology and Oral Rehabilitation
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023989

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.