UMIN-CTR Clinical Trial

Basic information
Public title	Development of novel miniscrew.
Acronym	Development of novel miniscrew.
Scientific Title	Development of novel miniscrew.
Scientific Title:Acronym	Development of novel miniscrew.
Region	Japan

Condition
Condition	Malocclusion
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Nowadays, orthodontic miniscrew implants were newly developed and have been well accepted in all over the world because this provides absolute anchorage without patient's compliance. Miniscrew can provide stable anchorage for various type of tooth movements, including intrusion, retraction, and protraction, resulting in achievements of ideal occlusion and facial balance. However, the clinical use of miniscrew implants especially for long time, accompanies some risks and complications. Screw failure is one of the most undesirable problems, and a recent review found an overall failure rate of 23.2%. This rate is significantly higher than the failure rate of dental implants for prosthetic restorations. Truly, in clinical orthodontics, several cases showed one or more experiences of screw failure, which affects treatment outcome and duration. Rarely, failed miniscrew could be a risk factor for pulmonary aspiration. Therefore, increasing the success rate of miniscrew implants in clinical orthodontics is an urgent issue. In this study, the aim is to develop a novel miniscrew with higher success rate, which contributes to a safe and effective orthodontic treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stability of miniscrew implants (at 1-3 months after implantation)
Key secondary outcomes	The tightening torque and loosening torque of miniscrew implants (after implantation immediately)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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	Device,equipment
Interventions/Control_1	Novel developed miniscrew (NDM) group: patients with implantation of NDM between the date of approval and March 2020. Duration of interventional study: During multi-bracket treatment (approximately 2-3 years) Number of intervention: Implant the required number of NDM needed to treat. However, the upper limit per patient to the six.
Interventions/Control_2	Conventional miniscrew (CM) group: patients treated with CM between the date of April 2008 and September 2015.
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	12 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients will have been diagnosed with the application of miniscrew implants between the date of approval and March 2020.
Key exclusion criteria	･Unmanageable severe systemic disease ･Unmanageable bleeding disorder, Uncooperative patients without motivation ･Drugs, alcohol, nicotine addiction patients, and dysfunction of treatment resistance for long time ･Xerostomia ･Opportunistic immunodeficiency and leukocyte dysfunction ･Diseases requiring a regular steroid ･Unmanageable endocrine disease ･Hypersensitivity to titanium/ titanium alloy ･Abnormal wound healing function ･Administered bisphosphonates ･Not in good general condition ･The implanted area has some problems such as inflammation, tumors, cysts, lesions, and trauma
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Eiji Middle name Last name Tanaka
Organization	Tokushima University Graduate School
Division name	Department of Orthodontics and Dentofacial Orthopedics, Institute of Biomedical Sciences
Zip code	7708504
Address	3-18-15, Kuramotocho, Tokushima, Tokushima, Japan
TEL	088-633-7357
Email	etanaka@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Keiichiro Middle name Last name Watanabe
Organization	Tokushima University Graduate School
Division name	Department of Orthodontics and Dentofacial Orthopedics, Institute of Biomedical Sciences
Zip code	7708504
Address	3-18-15, Kuramotocho, Tokushima, Tokushima, Japan
TEL	088-633-7357
Homepage URL
Email	nabe@tokushima-u.ac.jp

Sponsor
Institute	Department of Orthodontics and Dentofacial Orthopedics, Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department

Funding Source
Organization	BIODENT CORPORATION
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	IRB, Tokushima University Hospital
Address	Kuramoto-cho 2-50-1, Tokushima, Tokushima
Tel	0886339294
Email	awachiken@tokushima-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	2015 Year 11 Month 30 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	Completed
Date of protocol fixation	2015 Year 11 Month 30 Day
Date of IRB	2015 Year 11 Month 30 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 08 Month 31 Day
Date trial data considered complete	2020 Year 08 Month 31 Day
Date analysis concluded	2020 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 11 Month 17 Day
Last modified on	2020 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022830