UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of the effect of the mandibular osteotomy on the proximal segment in mandibular set-back
Acronym	Assessment of the effect of the mandibular osteotomy on the proximal segment in mandibular set-back
Scientific Title	Assessment of the effect of the mandibular osteotomy on the proximal segment in mandibular set-back
Scientific Title:Acronym	Assessment of the effect of the mandibular osteotomy on the proximal segment in mandibular set-back
Region	Japan

Condition
Condition	jaw deformity
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify which osteotomy strategy is the best way in mandibular set-back.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	temporomandibular joint disorder change the position of the condylar head
Key secondary outcomes	adverse events

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	15 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. patient who underwent mandibular osteotomy due to Jae deformity. 2. patients who visited us and took routine image exams. 3. sufficient medical record 4. more than 6 months follow-up.
Key exclusion criteria	1. past experience of mandibular osteotomy 2. jaw deformity related with general syndrome 3. jaw deformity related with cleft lip and palatal 4. genioplasty only, corticotomy only 5. no suitable patients with this study
Target sample size	129

Research contact person
Name of lead principal investigator	1st name Seigo Middle name Last name Ohba
Organization	Nagasaki University
Division name	Dep. Regenerative Oral Surgery
Zip code	852-8588
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7704
Email	sohba@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Seigo Middle name Last name Ohba
Organization	Nagasaki University
Division name	Dep. Regenerative Oral Surgery
Zip code	852-8588
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7704
Homepage URL
Email	sohba@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Nonne
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	Nagasaki University
Address	1-7-1 Sakamoto, Nagasaki
Tel	095-819-7704
Email	sohba@nagasaki-u.ac.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 06 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	129
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	Completed
Date of protocol fixation	2020 Year 05 Month 25 Day
Date of IRB	2020 Year 06 Month 15 Day
Anticipated trial start date	2020 Year 06 Month 30 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The article was accepted in the Journal of Cranio-Maxillo-Facial Surgery.

Management information
Registered date	2020 Year 05 Month 27 Day
Last modified on	2022 Year 07 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046288