UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044008 |
|---|---|
| Receipt number | R000050253 |
| Scientific Title | Development of a measuring machine for the load of a functional orthodontic appliance using a device with a force sensor |
| Date of disclosure of the study information | 2021/06/29 |
| Last modified on | 2024/12/03 13:55:26 |
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Basic information
Public title
Development of a measuring machine for the load of a functional orthodontic appliance using a device with a force sensor
Acronym
Development of a measuring machine for the load of a functional orthodontic appliance using a device with a force sensor
Scientific Title
Development of a measuring machine for the load of a functional orthodontic appliance using a device with a force sensor
Scientific Title:Acronym
Development of a measuring machine for the load of a functional orthodontic appliance using a device with a force sensor
Region
| Japan |
Condition
Condition
Skeletal class II with under growth of mandible
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish a load measurement system that reduces the time burden on the patient, and to compare the time required to measure the load between the conventional method and the method of this study.
Basic objectives2
Others
Basic objectives -Others
Accuracy of measurement values
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measured load
Key secondary outcomes
Time taken to measure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of load of generated by functional appliance
Interventions/Control_2
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
| 13 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are currently attending the Department of Orthodontics at Showa University Dental Hospital and meet the diagnostic criteria for skeletal maxillary protrusion.
(2) Patients who are between 6 and 12 years old at the time of obtaining consent.
(3) Patients who are scheduled to undergo orthodontic treatment after obtaining consent.
(4) Patients who have given written consent to participate in this study.
In addition, written consent from a substitute (guardian) must also be obtained.
(5) Patients who do not have any congenital diseases.
Key exclusion criteria
(1) Patients whose consent for research cannot be obtained from themselves or their guardians.
(2) Patients with congenital diseases.
(3) Patients with hyperactivity or other conditions that make it difficult to ensure safety when performing measurements.
(4) Patients who are judged to be ineligible by the physician in charge of the research.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Kawai |
Organization
Showa University dental hospital
Division name
Orthodontic
Zip code
145-8515
Address
Tokyo,ootaku,kitasenzoku 2-1-1
TEL
03-3787-1151
onimaru@dent.Showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Minako |
| Middle name | |
| Last name | Onimaru |
Organization
Showa university dental hospital
Division name
Orthodontic
Zip code
145-8515
Address
Tokyo,ootaku,kitasenzoku 2-1-1
TEL
03-3787-1151
Homepage URL
onimaru@dent.Showa-u.ac.jp
Sponsor or person
Institute
Showa university
Institute
Department
Personal name
Funding Source
Organization
Showa University
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
Showa university dental hospital IRB
Address
Tokyo,ootaku,kitasenzoku 2-1-1
Tel
03-3787-115
dh-ctrial@ofc.showa-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
| 2021 | Year | 06 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 29 | 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
| 2021 | Year | 04 | Month | 21 | Day |
Last modified on
| 2024 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050253
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/10/23 | UMIN研究計画.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/10/23 | 仕様書.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/10/23 | 計測例 UMIN.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/50253
