UMIN-CTR Clinical Trial

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
Email	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
Email	onering2007@yahoo.co.jp

Sponsor
Institute	Toyooka Public Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046941