UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038588
Receipt number R000043975
Scientific Title The assessment of the dynamic changes of the proximal segment after the mandibular osteotomy
Date of disclosure of the study information 2019/11/14
Last modified on 2021/11/18 02:15:57

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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 or person

Institute

Nagasaki University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043975


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name