UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031362 |
|---|---|
| Receipt number | 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 12:21:15 |
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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
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
ctanika@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Dental hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032872
