UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035211 |
|---|---|
| Receipt number | R000040129 |
| Scientific Title | Analysis of the occlusion changes after the oral surgery operation by the exact analysis with the silicon bytes |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2018/12/10 21:05:00 |
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Basic information
Public title
Analysis of the occlusion changes after the oral surgery operation by the exact analysis with the silicon bytes
Acronym
Analysis of the occlusion changes after the oral surgery operation by the exact analysis with the silicon bytes
Scientific Title
Analysis of the occlusion changes after the oral surgery operation by the exact analysis with the silicon bytes
Scientific Title:Acronym
Analysis of the occlusion changes after the oral surgery operation by the exact analysis with the silicon bytes
Region
| Japan |
Condition
Condition
Jaw Deformities, Jaw Tumors
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Quantification of the occlusion changes by the operations
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Including the contact area of the tooth, the number of the contact points, and the distribution (right and left, overall balance)
(preoperation, postoperation; 1/3/6/12 months)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Exact measurement of the silicon bytes
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who receive the operation with the resection of jaw bone(s)
Key exclusion criteria
None
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yohei Oda |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Reconstructive Surgery for Oral and Maxillofacial Region
Zip code
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514 JAPAN
TEL
025-227-2880
y-oda@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Oda |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Reconstructive Surgery for Oral and Maxillofacial Region
Zip code
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514 JAPAN
TEL
025-227-2880
Homepage URL
y-oda@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2019 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | 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
| 2018 | Year | 12 | Month | 10 | Day |
Last modified on
| 2018 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040129
