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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029386
Receipt No. 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

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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
Email 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
Email miyashita@dent.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033572

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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