UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038096 |
|---|---|
| Receipt number | 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 | 2024/12/16 15:13:31 |
* 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
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
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
r-nishimura@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://mol.medicalonline.jp/library/journal/dow
Publication of results
Partially published
Result
URL related to results and publications
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://mol.medicalonline.jp/library/journal/dow
Number of participants that the trial has enrolled
40
Results
Two months of button exercise increased oral function in young people. In addition, the lip closure force was maintained even after button exercise was discontinued.
Results date posted
| 2022 | Year | 09 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
40　women aged 20 to 30 years
Participant flow
To exclude the effects of dental arrangement on button movement, subjects with one or more of the following criteria were excluded: (i) less than two anterior maxillary teeth, (ii) less than two anterior mandibular teeth, (iii) less than 20 teeth in total, (iv) wearing dentures, (v) fitted with an orthodontic appliance, (vi) overjet of 0 mm or less, and (v) overjet of 5 mm or more. Twenty subjects were allocated to each of the two groups: the intervention or control group. Button movement was performed for 8 weeks in the intervention group.
Adverse events
None
Outcome measures
Lip-closing force
Tongue pressure
Buccal pressure
Oral diadochokinesis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042617
