UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051424 |
|---|---|
| Receipt number | R000058662 |
| Scientific Title | The Effect of Masticatory Training on Mandibular Dentition and Oral Function during Slow maxillary expansion Treatment |
| Date of disclosure of the study information | 2023/06/23 |
| Last modified on | 2023/06/23 12:47:38 |
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Basic information
Public title
The Effect of Masticatory Training on Mandibular Dentition and Oral Function during Slow maxillary expansion Treatment
Acronym
The Effect of Masticatory Training on Mandibular Dentition and Oral Function during Slow maxillary expansion Treatment
Scientific Title
The Effect of Masticatory Training on Mandibular Dentition and Oral Function during Slow maxillary expansion Treatment
Scientific Title:Acronym
The Effect of Masticatory Training on Mandibular Dentition and Oral Function during Slow maxillary expansion Treatment
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To research the effect of training with Gum to oral function in children during Slow maxillary expansion Treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) lip pressure
2) tongue pressure
3) tongue and lip movement
4) bite force, occlusal contact area, occlusal balance
5) chewing ability, masticatory path
6) electromyogram of masticatory muscle
7) questionnaire
8) facial scanning
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral training with chewing gum during the use of maxillary gradual expansion
Interventions/Control_2
No intervention
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
| 5 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
From 4 years old to 8 years old.
Mixed dentition patients with maxillary stenosis who came to the orthodontic clinic of our university hospital. Mixed dentition patients who require treatment for maxillary expansion using a lateral expander.
Key exclusion criteria
Patients with congenital diseases with maxillofacial malformations
Patients with severely carious teeth with crown decay
Patients with congenital defects of permanent teeth
History of surgical treatment for nasopharyngeal disease
History of surgical treatment for tongue disorder(e.g., glossoglossal band scleroderma)
Patients with vomiting reflex
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Negishi |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Orthodontics
Zip code
271-8587
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL
047-360-9410
negishi.shinichi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Ishii |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Orthodontics
Zip code
271-8587
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL
047-360-9412
Homepage URL
ishii.kaori@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Dentistry at Matsudo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board in Nihon University School of Dentistry at Matsudo
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
Tel
047-368-6111
kj.md.ml@nihon-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
| 2023 | Year | 06 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058662
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
