UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of myofunctional therapy on subjects with lip incompetence - Multimodality analysis
Title of the study (Brief title)	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	Jun Miyamoto
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU)
Division name	Maxillofacial Orthognathics
Address	Bunkyo-ku Yushima 1-5-45 Tokyo
TEL	03-5803-5569
Email	mjmort@tmd.ac.jp

Public contact
Name of contact person	Jun Miyamoto
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU)
Division name	Maxillofacial Orthognathics
Address	Bunkyo-ku Yushima 1-5-45 Tokyo
TEL	03-5803-5569
Homepage URL
Email	mjmort@tmd.ac.jp

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

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 04 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036426