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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031362
Receipt No. R000032872
Scientific Title The Efficacy of Computer-Based Pre Operative Planning System for Orthognathic Surgery and Fabrication of Intra-operative Positioning Guides
Date of disclosure of the study information 2018/02/20
Last modified on 2018/02/19

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Basic information
Public title The Efficacy of Computer-Based Pre
Operative Planning System for
Orthognathic Surgery and Fabrication of
Intra-operative Positioning Guides
Acronym Efficacy of Computer-Based Pre Operative Planning System
Scientific Title The Efficacy of Computer-Based Pre
Operative Planning System for
Orthognathic Surgery and Fabrication of
Intra-operative Positioning Guides
Scientific Title:Acronym Efficacy of Computer-Based Pre Operative Planning System
Region
Japan

Condition
Condition Jaw deformity
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of the computer-based system for the virtual pre-surgical planning via using CAD/CAM fabricated positioning guides to ensure final maxillary and mandibular position in patients with jaw deformities.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Differences between the planned outcomes and postoperative outcomes of the maxillary and mandibular position
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Surgical guides (during operation)
Interventions/Control_2 Application of barium when taking CT
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients having a two-jaw surgery in the Osaka University Hospital.
Overjet ranged from -10 mm to 0 mm.
Key exclusion criteria Patients having missing teeth (the number of the missing teeth is greater than six; (excluding the third molars).
Patients having CO-CR discrepancy (greater than 3 mm)
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chihiro Tanikawa
Organization Osaka University Dental hospital
Division name Department of Orthodontics and Dentofacial Orthopedics
Zip code
Address 1-8 Yamadaoka Suita Osaka 565-0871 Japan
TEL +81-6-6879-2958
Email ctanika@dent.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chihiro Tanikawa
Organization Osaka University Dental hospital
Division name Department of Orthodontics and Dentofacial Orthopedics
Zip code
Address 1-8 Yamadaoka Suita Osaka 565-0871 Japan
TEL +81-6-6879-2958
Homepage URL
Email ctanika@dent.osaka-u.ac.jp

Sponsor
Institute Osaka University Dental hospital
Institute
Department

Funding Source
Organization Osaka University Dental hospital
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
2018 Year 02 Month 20 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
2018 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 08 Month 31 Day
Date trial data considered complete
2021 Year 08 Month 31 Day
Date analysis concluded
2022 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 19 Day
Last modified on
2018 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032872

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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