UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046941 |
|---|---|
| Receipt number | R000053558 |
| Scientific Title | Evaluation of the usefulness of MFT treatment support applications as a medical device program |
| Date of disclosure of the study information | 2022/02/21 |
| Last modified on | 2022/02/18 10:51:18 |
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Basic information
Public title
Development of MFT treatment support application as a medical device program
Acronym
Development of MFT treatment support application as a medical device program
Scientific Title
Evaluation of the usefulness of MFT treatment support applications as a medical device program
Scientific Title:Acronym
Evaluation of the usefulness of MFT treatment support applications as a medical device program
Region
| Japan |
Condition
Condition
Malocclusion
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to develop an online MFT using a smartphone app between hospital visits and to verify its effect through randomized clinical studies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cephalo analysis
Key secondary outcomes
Overjet, overbite
Lip closure
Chewing ability
Bite force quotient
Oral scanning
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Use MFT + MFT support app
Interventions/Control_2
Use MFT + dummy app
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who visited Tokyo Medical and Dental University Hospital Orthodontics
Dental age IIC to IIIC
Those who have been diagnosed with maxillary prognathism or open bite
Those who have decided to use a habit removal device (removable type) in treatment
Those who will be treated with MFT
Key exclusion criteria
Persons with congenital anomalies such as cleft lip and palate and systemic diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ono |
Organization
Tokyo Medical and Dental University
Division name
orthodontic
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
0358034146
t.ono.orts@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Okihara |
Organization
Tokyo Medical and Dental University
Division name
orthodontic
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
0358034146
Homepage URL
hideorts@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Doctorbook Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo medical and Dental University ethics commity
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
0358034712
jimubu-sanren.adm@tmd.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
| 2022 | Year | 02 | Month | 21 | 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 | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 18 | Day |
Last modified on
| 2022 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053558
