UMIN-CTR Clinical Trial

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
Email	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
Email	hideorts@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053558