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
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
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
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
