UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046459
Receipt number R000052922
Scientific Title A retrospective study of bone healing after maxillary osteotomy
Date of disclosure of the study information 2022/02/01
Last modified on 2022/05/02 12:03:25

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Basic information

Public title

A retrospective study of bone healing after maxillary osteotomy

Acronym

A retrospective study of bone healing after maxillary osteotomy

Scientific Title

A retrospective study of bone healing after maxillary osteotomy

Scientific Title:Acronym

A retrospective study of bone healing after maxillary osteotomy

Region

Japan


Condition

Condition

jaw deformity

Classification by specialty

Oral surgery Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Establishment of treatment

Basic objectives2

Others

Basic objectives -Others

Investigation of factors associated with bone healing

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

gap distance between bones

Key secondary outcomes

each collected item


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

jaw deformity patients who underwent maxillary osteotomy at Nagasaki University Hospital from April 2011 to September 2020

Key exclusion criteria

cleft lip and palate patient

Target sample size

33


Research contact person

Name of lead principal investigator

1st name Kota
Middle name
Last name Morishita

Organization

Nagasaki University

Division name

Oral Surgery

Zip code

852-8588

Address

1-7-1 Sakamoto, Nagasaki-shi

TEL

095-819-7698

Email

k-morishita@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Kota
Middle name
Last name Morishita

Organization

Nagasaki University

Division name

Oral Surgery

Zip code

852-8588

Address

1-7-1 Sakamoto, Nagasaki-shi

TEL

095-819-7698

Homepage URL


Email

k-morishita@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 Hospital

Address

1-7-1 Sakamoto, Nagasaki-shi

Tel

095-819-7229

Email

gaibushikin@ml.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

2022 Year 02 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


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

2021 Year 10 Month 21 Day

Date of IRB

2021 Year 12 Month 27 Day

Anticipated trial start date

2022 Year 02 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

age, gender, medical history, hemoglobin, serum albumin, cephalometric findings, operative findings, CT findings


Management information

Registered date

2021 Year 12 Month 24 Day

Last modified on

2022 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052922