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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038096
Receipt No. R000042617
Scientific Title Examination of the effect of lip closure training on oral function
Date of disclosure of the study information 2019/09/26
Last modified on 2021/03/27

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Basic information
Public title Examination of the effect of lip closure training on oral function
Acronym Examination of the effect of lip closure training on oral function
Scientific Title Examination of the effect of lip closure training on oral function
Scientific Title:Acronym Examination of the effect of lip closure training on oral function
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effects of lip closure training using buttons on oral function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of lip closure power every 2 weeks
Key secondary outcomes Oral function evaluation (tongue pressure, cheek pressure, articulation test) is conducted every 2 weeks.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 The lip closure training group conducts daily training for two months.
Interventions/Control_2 The non-intervention group does not carry out training.
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
40 years-old >
Gender Male and Female
Key inclusion criteria 1) Those who have 2 or more maxillary anterior teeth and 2 or more mandibular anterior teeth, and a total of 20 or more teeth
2) Those who are 20 years old or older and younger than 40 years old (who have completed the development of lip closure power)
3) Persons who can obtain written consent from the person concerned about participation
Key exclusion criteria 1) History of cerebral infarction, nervous system disease, head and neck injury, surgery
2) Denture users
3) Persons with orthodontic appliances
4) Person who has a stomatognathic face disease
5) Overjet 0mm or less or 5mm or more
6) Those who have taken the classes of the research supervisor and research researcher according to the exclusion criteria
7) Other persons who are judged to be inappropriate by the person in charge of the research
Target sample size 40

Research contact person
Name of lead principal investigator
1st name MARIKO
Middle name
Last name NAITO
Organization Hiroshima University, Graduate School of Biomedical and Health Sciences
Division name Oral Epidemiology
Zip code 734-8553
Address 1-2-3,Kasumi,Minami-ku, Hiroshima
TEL 082-257-5959
Email naito@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name RUMI
Middle name
Last name NISHIMURA
Organization Hiroshima University, Graduate School of Biomedical and Health Sciences
Division name Oral Epidemiology
Zip code 734-8553
Address 1-2-3,Kasumi,Minami-ku, Hiroshima
TEL 082-257-5795
Homepage URL
Email r-nishimura@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Hiroshima 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 center for integrated medical research, Hiroshima University
Address 1-2-3,Kasumi,Minami-ku, Hiroshima
Tel 082-257-1573
Email iryo-seisaku@office.hiroshima-u.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
2019 Year 09 Month 26 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 40
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 No longer recruiting
Date of protocol fixation
2019 Year 09 Month 24 Day
Date of IRB
2019 Year 09 Month 30 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2020 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
2019 Year 09 Month 25 Day
Last modified on
2021 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042617

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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