UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020944
Receipt number 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 09:22:18

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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