UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044652 |
|---|---|
| Receipt number | R000050999 |
| Scientific Title | Effectiveness of oral myofunctional therapy combined with respiratory adjustment |
| Date of disclosure of the study information | 2021/06/25 |
| Last modified on | 2021/06/29 07:37:39 |
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Basic information
Public title
Effectiveness of oral myofunctional therapy combined with respiratory adjustment
Acronym
Effectiveness of oral myofunctional therapy combined with respiratory adjustment
Scientific Title
Effectiveness of oral myofunctional therapy combined with respiratory adjustment
Scientific Title:Acronym
Effectiveness of oral myofunctional therapy combined with respiratory adjustment
Region
| Japan |
Condition
Condition
Mouth breathing
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hypothesizing that promoting nasal breathing will have a lasting effect on OMFTs, we will focus on yoga and compare its effectiveness in combination with oral myofunctional therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak Nasal Inspiratory Flow
Lip Closure Force
Tongue Up Force
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
yoga
Interventions/Control_2
MFT
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
person with a nasal obstruction
Key exclusion criteria
In treatment of ENT
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | SUZUKI |
| Middle name | |
| Last name | HIROSHI |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Oral Function and Fixed Prosthodontics,
Zip code
271-0061
Address
2-870-1 Sakaecho Nishi Matsudo Chiba 271-0061
TEL
047-360-9642
suzuki.hiroshi91@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | SUZUKI |
| Middle name | |
| Last name | HIROSHI |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Oral Function and Fixed Prosthodontics,
Zip code
271-0061
Address
2-870-1 Sakaecho Nishi Matsudo Chiba 271-0061
TEL
047-360-9642
Homepage URL
suzuki.hiroshi91@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Dentistry at Matsudo
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Dentistry at Matsudo
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
Nihon University School of Dentistry at Matsudo
Address
2-870-1 Sakaecho Nishi Matsudo Chiba 271-0061
Tel
047-360-9642
suzuki.hiroshi91@nihon-u.ac.jo
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
| 2021 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2020 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 25 | Day |
Last modified on
| 2021 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050999
