UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032179
Receipt number R000036426
Scientific Title Effect of myofunctional therapy on subjects with lip incompetence - Multimodality analysis
Date of disclosure of the study information 2018/04/10
Last modified on 2018/04/10 12:35:27

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Basic information

Public title




Effect of myofunctional therapy on subjects with lip incompetence - Multimodality analysis

Acronym

Effect of myofunctional therapy on subjects with lip incompetence

Scientific Title




Effect of myofunctional therapy on subjects with lip incompetence - Multimodality analysis

Scientific Title:Acronym

Effect of myofunctional therapy on subjects with lip incompetence

Region

Japan


Condition

Condition

Subjects with lip incompetence

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The peri-oral muscles-icluding orbicularis oris-re critical in
maintaining equilibrium in tooth position. Lip incompetence (LI) can thus be a factor in
malocclusion. We therefore aimed to validate a technique to evaluate not only muscle activity via
electromyography (EMG) but also muscle endurance and fatigue via blood flow (BF) for LI.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change f blood flow and muscle activity in superior and inferior orbicularis oris muscle

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Traction plates were inserted
in the upper and lower oral vestibules, and the maximum contractile
tension of the orbicularis oris muscle (single repetition of maximal
output: 1-RM) was measured by pulling against the plate connected
to the tension gauge using
a custom-made traction device until the plate is pulled out of the
mouth. Accurate 30, 50 and 70 per cent load values were
then calculated based on this maximum contractile tension for each
subject.
Blood flow in the superior and inferior orbicularis oris was
measured using a laser speckle imager.
EMG activity was simultaneously recorded
under the same conditions as for BF recording

Interventions/Control_2

After orbital muscle contraction training, measurement is performed under the same site condition as before 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

18 years-old <=

Age-upper limit

35 years-old >=

Gender

Male and Female

Key inclusion criteria

Each patient fulfilled the following criteria:
1.Subjects with lop incompetence
2. Postgrowth
adult subjects over 18 years of age. The Cervical Vertebral
Maturation method was used to assess the lateral cephalograms,
and all subjects were in CS6.

Key exclusion criteria

Exclusion criteria were:
1. any nasal deformity, infection, allergy or nasal disease; 2. congenital
malformation including clefting and temporomandibular joint
dysfunction; and 3. current use of medications that affect muscle
activity. Prior to the experiment, we confirmed that there was no significant
difference in BF or EMG activity between the right and left
hemispheres of the orbicularis oris muscle.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Miyamoto

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU)

Division name

Maxillofacial Orthognathics

Zip code


Address

Bunkyo-ku Yushima 1-5-45 Tokyo

TEL

03-5803-5569

Email

mjmort@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Jun Miyamoto

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU)

Division name

Maxillofacial Orthognathics

Zip code


Address

Bunkyo-ku Yushima 1-5-45 Tokyo

TEL

03-5803-5569

Homepage URL


Email

mjmort@tmd.ac.jp


Sponsor or person

Institute

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU)

Institute

Department

Personal name



Funding Source

Organization

Scientific Research
Projects from the Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2018 Year 04 Month 10 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


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

Open public recruiting

Date of protocol fixation

2018 Year 04 Month 10 Day

Date of IRB


Anticipated trial start date

2018 Year 04 Month 10 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

2018 Year 04 Month 10 Day

Last modified on

2018 Year 04 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036426


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name