UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019821 |
|---|---|
| Receipt number | R000022830 |
| Scientific Title | Development of novel miniscrew. |
| Date of disclosure of the study information | 2015/11/30 |
| Last modified on | 2020/11/20 09:55:29 |
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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
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
nabe@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Orthodontics and Dentofacial Orthopedics, Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022830
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