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 2023/03/29 11:12:52

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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 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

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

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

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

2023 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 09 Month 25 Day

Last modified on

2023 Year 03 Month 29 Day



Link to view the page

Value
https://center6.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