UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029386 |
|---|---|
| Receipt number | R000033572 |
| Scientific Title | Evaluation of virtual surgical planned jaw bone reconstruction with maintenance of maxillomandibular relation |
| Date of disclosure of the study information | 2017/10/02 |
| Last modified on | 2017/10/02 17:09:24 |
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Basic information
Public title
Evaluation of virtual surgical planned jaw bone reconstruction with maintenance of maxillomandibular relation
Acronym
Evaluation of virtual surgical planned jaw bone reconstruction with maintenance of maxillomandibular relation
Scientific Title
Evaluation of virtual surgical planned jaw bone reconstruction with maintenance of maxillomandibular relation
Scientific Title:Acronym
Evaluation of virtual surgical planned jaw bone reconstruction with maintenance of maxillomandibular relation
Region
| Japan |
Condition
Condition
Patients with head and neck diseases who will undergo jaw bone reconstruction (head and neck tumor, osteonecrosis, and osteomyelitis)
Classification by specialty
| Oto-rhino-laryngology | Oral surgery | Plastic surgery |
| Dental medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficiency of virtual surgical planned jaw bone reconstruction with management of maxillomandibular relation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)the postoperative evaluation of jaw bone morphology
1)comparison between 3D simulation and postoperative jaw bone-morpholohy
2)comparison between 3D application and traditional method
(2)the postoperative evaluation of maxillomandibular relation
1)comparison between 3D simulation and poroperative jaw bone morphology
2)comparison between 3D printer application and traditional method
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
3Dprinter application and management of maxillomandibular relation for jaw bone reconstruction
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)virtual surgical planned group:patients who will undergo jaw bone reconstruction after maxillomandibular resection due to head and neck tumor, osteonecrosis, and osteomyelitis.
(2)Conventionally reconstructed group:patient whose jaw bones were reconstructed by the conventional method after ablative surgery of head and neck tumors in Tohoku University Hospital from April 2012 until October 2016
(3)older than age 20 at the time of obtaining the consent
Key exclusion criteria
(1)Pregnant or breast-feeding females and females who have a possibility of pregnancy
(2)Patients with psychosis
(3)Patients who have insufficient capacity to judge
(4)Patients who have an allergy to resin
(5)Any other inadequency for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Miyashita |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Oral and Maxillofacial Surgery
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227176350
miyashita@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Miyashita |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Oral and Maxillofacial Surgery
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227178350
Homepage URL
miyashita@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 10 | 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
| 2017 | Year | 10 | Month | 02 | Day |
Last modified on
| 2017 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033572
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
