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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022182
Receipt No. 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

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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
Institute Okayama University
Institute
Department

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
URL(English) https://upload.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


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