UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041105 |
|---|---|
| Receipt number | R000046941 |
| Scientific Title | Utility of Creating Surgical Guide Using Sterilizable and Inexpensive Dental Impression Silicon in Free vascularized bone Flap Mandibular and Maxillary Bone Reconstruction |
| Date of disclosure of the study information | 2020/07/14 |
| Last modified on | 2020/07/14 19:10:30 |
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Basic information
Public title
Utility of Creating Surgical Guide Using Sterilizable and Inexpensive Dental Impression Silicon in Free vascularized bone Flap Mandibular and Maxillary Bone Reconstruction
Acronym
Utility of Creating Surgical Guide Using Dental Impression Silicon in Free vascularized bone Flap Mandibular and Maxillary Bone Reconstruction
Scientific Title
Utility of Creating Surgical Guide Using Sterilizable and Inexpensive Dental Impression Silicon in Free vascularized bone Flap Mandibular and Maxillary Bone Reconstruction
Scientific Title:Acronym
Utility of Creating Surgical Guide Using Sterilizable and Inexpensive Dental Impression Silicon in Free vascularized bone Flap Mandibular and Maxillary Bone Reconstruction
Region
| Japan |
Condition
Condition
Head and neck cancer, mandibular gingival cancer, benign tumor of the mandible, osteonecrosis of the jaw, maxillary cancer, benign tumor of the maxilla
Classification by specialty
| Surgery in general | Oto-rhino-laryngology | Oral surgery |
| Plastic surgery | Operative medicine | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We introduce a method in which we perform osteotomy on the 3D model preoperatively by using a guide molded from the inexpensive and easy-to-use silicon Protesil labor to the correct bone size and osteotomy angle.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of bone model length and angle in preoperative simulation surgery with bone length and angle in postoperative 3DCT
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with head and neck cancer or jaw osteonecrosis or benign head and neck tumors undergoing lesion resection and reconstruction with vascuralized bone flap
Key exclusion criteria
(1) Patients under 10 years old
(2) Patients who do not get written consent
(3) Patients who cannot be examined by MRI
(4) Patients who are judged to be inappropriate by other researchers
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Chihiro |
| Middle name | |
| Last name | Matsui |
Organization
Junendo university school of medicine
Division name
Plastic and reconstructive surgery
Zip code
113-8431
Address
3-1 3chome Hongo Bunkyoku Tokyo Japan
TEL
03-3813-3111
onering2007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Matsui |
Organization
Toyooka Public Hospital
Division name
Oral and Maxillofacial surgery
Zip code
668-8501
Address
1094 Tobera, Toyooka-city, Hyogo, Japan
TEL
0796-22-6111
Homepage URL
onering2007@yahoo.co.jp
Sponsor or person
Institute
Toyooka Public Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University school of medicine
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
Toyooka Public Hospital
Address
1094 Tobera, Toyooka-city, Hyogo, Japan
Tel
0796-22-6111
onering2007@yahoo.co.jp
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
| 2020 | Year | 07 | Month | 14 | 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
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study. With respect to a case where a self-made guide has already been used for osteotomy of a bone flap, the model size and angle before surgery and the CT bone size and angle after surgery will be measured and analyzed.
Management information
Registered date
| 2020 | Year | 07 | Month | 14 | Day |
Last modified on
| 2020 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046941
| Research Plan | |
|---|---|
| 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 |
