UMIN-CTR Clinical Trial

Basic information
Public title	The assessment of the dynamic changes of the proximal segment after the mandibular osteotomy
Acronym	The assessment of the dynamic changes of the proximal segment after the mandibular osteotomy
Scientific Title	The assessment of the dynamic changes of the proximal segment after the mandibular osteotomy
Scientific Title:Acronym	The assessment of the dynamic changes of the proximal segment after the mandibular osteotomy
Region	Japan

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

Objectives
Narrative objectives1	to detect the risk factors of the proximal segmental deviation after mandibular osteotomy.
Basic objectives2	Others
Basic objectives -Others	the position of the condylar head after the mandibular osteotomy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the proximal segmental deviation
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who underwent the mandibular osteotomy for correcting their mandibular protrusion.
Key exclusion criteria	Cleft lit and palate
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Seigo Middle name Last name OPhba
Organization	nagasaki University
Division name	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	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	Nagasaki University
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@nnagasaki-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	2019 Year 11 Month 14 Day

Related information
URL releasing protocol	https://reader.elsevier.com/reader/sd/pii/S1010518220301104?token=E7B33022D8EB5699119E33F920959A8128
Publication of results	Published

Result
URL related to results and publications	https://reader.elsevier.com/reader/sd/pii/S1010518220301104?token=E7B33022D8EB5699119E33F920959A8128
Number of participants that the trial has enrolled	90
Results	This study suggests that SLO with the physiological positioning strategy (PPS) should bepreferred over IVRO with the PPS whenever possible.
Results date posted	2021 Year 11 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	IVRO 25 SSRO 65 There were no significant differences in the patients' age or degree of mandibular setback among the groups.
Participant flow	routine image exams after surgery.
Adverse events	TMD in some patients.
Outcome measures	prevalence of TMD. Cephalometric analysis.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 11 Month 14 Day
Date of IRB	2019 Year 12 Month 17 Day
Anticipated trial start date	2019 Year 12 Month 20 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	publish.

Management information
Registered date	2019 Year 11 Month 14 Day
Last modified on	2021 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043975