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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020944
Receipt No. R000024167
Scientific Title A clinical application of a novel auxiliary skeletal anchorage device.
Date of disclosure of the study information 2016/04/01
Last modified on 2017/09/29

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Basic information
Public title A clinical application of a novel auxiliary skeletal anchorage device.
Acronym A clinical application of a novel auxiliary skeletal anchorage device.
Scientific Title A clinical application of a novel auxiliary skeletal anchorage device.
Scientific Title:Acronym A clinical application of a novel auxiliary skeletal anchorage device.
Region
Japan

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

Objectives
Narrative objectives1 In contemporary orthodontic treatment, miniscrews are frequently used for absolute anchorage because of their ease of placement and removal, lower surgical stress and lower discomfort. Miniscrews have enabled numerous orthodontic treatments that were difficult with conventional appliances: eg, mesial movement of a molar in a patient with oligodontia, distal movement of the maxillary and mandibular teeth, and improvement of an open bite caused by intruding posterior teeth. Currently, the usefulness of miniscrews has been conclusively shown with a high level of evidence. However, their disadvantage is an approximately 20% failure rate, which is primarily attributed to the low mechanical stability between the miniscrew and cortical bone and to the miniscrew's close proximity to the dental root. Prevention of miniscrew failure thus requires meeting 2 crucial conditions: increased mechanical stability, achieved by increasing the contact area between the miniscrew and the cortical bone, and prevention of root proximity by shortening the miniscrew. No currently available miniscrews or skeletal anchorage devices meet these conditions while remaining minimally invasive. Accordingly, we developed an auxiliary skeletal anchorage device that is used in conjunction with a miniscrew to increase its stability and ultimately helping to avoid root proximity with a shorter miniscrew. The purpose of this study is to evaluate the effectiveness of the auxiliary device in orthodontic treatment.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The failure rate of screw
Key secondary outcomes ・Evaluation about inflammation of periodontal tissue
・Quality of bone and teeth around the screw.
・Movement of the teeth during orthodontic therapy.
・Evaluation about pain and discomfort
・Distance between dental roots and the screw
・Movement of the screw during orthodontic therapy.
・Duration of therapy・Risk factor of failed screw
・Evaluation of oral hygiene
・Change of craniofacial morphology and stomatognathic function.

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 Miniscrew with the auxiliary skeletal anchorage device group:patients with implantation of Novel miniscrew between the date of approval and March 2025.
period of intervention:During orthodontic treatment. (approximately 2-3 years)
Interventions/Control_2 Conventional miniscrew group: patients treated with Conventional miniscrew after the date of 2004.
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
0 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria Patients will have been diagnosed with the application of miniscrew between the date of approval and March 2025.
Key exclusion criteria ・The patient who has orthodontic treatment history.
・The patient with lack of many teeth and extensive dental prostheses
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shouichi Miyawaki
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Department of Orthodontics
Zip code
Address 8-35-1, Sakuragaoka, Kagoshima, Japan
TEL 099-275-6250
Email miyawaki@dent.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Tomonari
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Department of Orthodontics
Zip code
Address 8-35-1, Sakuragaoka, Kagoshima, Japan
TEL 099-275-6252
Homepage URL
Email piroshi@dent.kagoshima-u.ac.jp

Sponsor
Institute Department of Orthodontics , Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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
Address
Tel
Email

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 鹿児島大学病院(鹿児島県)     Kagoshima University Medsical
                 and Dental Hospital

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 01 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
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 08 Day
Last modified on
2017 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024167

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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