UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022182
Receipt number R000025557
Scientific Title Comprehensive clinical evaluation of indirect bonding method in orthodontic treatment
Date of disclosure of the study information 2016/05/02
Last modified on 2020/08/24 14:25:11

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Basic information

Public title

Comprehensive clinical evaluation of indirect bonding method in orthodontic treatment

Acronym

Comprehensive clinical evaluation of indirect bonding method

Scientific Title

Comprehensive clinical evaluation of indirect bonding method in orthodontic treatment

Scientific Title:Acronym

Comprehensive clinical evaluation of indirect bonding method

Region

Japan


Condition

Condition

Malocclusion

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Accurate bracket positioning is essential for edgewise orthodontic treatment. This study demonstrates the comprehensive clinical evaluation of indirect bonding method. We perform a detailed comparison of the indirect bonding method with the direct bonding method.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

1) Treatment time (Months)
2) Comparison of occlusal index between pre-treatment and post-treatment (Scores)
3)Discomfort at the time of bonding (VAS score)
4)Oral hygiene after bonding (Plaque Control Record; %)

Key secondary outcomes

1) Chair time (Minutes)
2) Failure rate (Times)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Direct bonding method without cores (technical material)

Interventions/Control_2

Indirect bonding method using cores (technical material)

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

1)Patients with malocclusion
2)Outpatients visiting Department of Orthodontics, Okayama University Hospital
3)More than 12 year old patients with all permanent teeth
4)Underage patients with a consent of their parent, person in parental authority, spouse, adult brother and sister, grandparent, relative, guardian, and curator.

Key exclusion criteria

1)Patients with malocclusion
2)Patients with amelogenesis imperfecta or enamel hypoplasia
3)Patients with vomiting reflex
4)Patients with primary teeth
5)Patients with jaw deformity or syndrome
6)patients treated by minor tooth movement
7)Patients with poor oral hygiene
8)Patients who will not be able to continue the treatment until finishing the treatment
9)Inappropriate patients judged by principal investigator or members of this study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Kamioka

Organization

Graduate School of Medicine, Dentistry and Pharmaceutical Science, Okayama University

Division name

Department of orthodontics

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama

TEL

086-235-6690

Email

kamioka@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Murakami

Organization

Okayama University Hospital

Division name

Department of Orthodontics

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama

TEL

086-235-6692

Homepage URL


Email

tmuraka@md.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University

Institute

Department

Personal name



Funding Source

Organization

Okayama University

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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 02 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

Open public recruiting

Date of protocol fixation

2014 Year 12 Month 16 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 07 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 05 Month 02 Day

Last modified on

2020 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025557


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name