UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041958
Receipt number R000047890
Scientific Title A new method for the treatment of intractable bony ankylosis of the temporomandibular joint utilizing intentional pseudoarthrosis
Date of disclosure of the study information 2020/10/01
Last modified on 2020/09/30 19:31:33

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Basic information

Public title

A new method for the treatment of intractable bony ankylosis of the temporomandibular joint utilizing intentional pseudoarthrosis

Acronym

A new method for the treatment of bony ankylosis of the temporomandibular joint

Scientific Title

A new method for the treatment of intractable bony ankylosis of the temporomandibular joint utilizing intentional pseudoarthrosis

Scientific Title:Acronym

A new method for the treatment of bony ankylosis of the temporomandibular joint

Region

Japan


Condition

Condition

bony ankylosis of the temporomandibular joint

Classification by specialty

Oral surgery Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

There are two major treatment options for bony ankylosis. One treatment is to use artificial joint, and another is to use interpositional graft. However, most cases recognized early recurrence a few months after arthroplasty and resulted in unsatisfactory results. Under these circumstances, we develop new method for these intractable bony ankylosis, named intentional pseudoarthrosis method.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Amount of opening mouth 1 year after operation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Osteotomy of temporomandibular joint and attachment of internal distraction device

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

Bony ankylosis of temporomandibular joint

Key exclusion criteria

Patients with multiple organ failure

Target sample size

4


Research contact person

Name of lead principal investigator

1st name Mine
Middle name
Last name Ozaki

Organization

Kyorin University School of Medicine

Division name

Department of Plastic Surgery

Zip code

181-8611

Address

6-20-2, Shinkawa, Mitaka, Tokyo

TEL

0422-47-5511

Email

zakimin@nifty.com


Public contact

Name of contact person

1st name Mine
Middle name
Last name Ozaki

Organization

Kyorin University School of Medicine

Division name

Department of Plastic Surgery

Zip code

181-8611

Address

6-20-2, Shinkawa, Mitaka, Tokyo

TEL

0422-47-5511

Homepage URL


Email

zakimin@nifty.com


Sponsor or person

Institute

Kyorin University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

No need

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

Public fund managemant, kyorin University

Address

6-20-2, Shinkawa, Mitaka, Tokyo

Tel

0422-47-5511

Email

kenkyushien@ks.kyorin-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 10 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

Open public recruiting

Date of protocol fixation

2014 Year 07 Month 01 Day

Date of IRB

2020 Year 12 Month 31 Day

Anticipated trial start date

2014 Year 07 Month 01 Day

Last follow-up date

2025 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 09 Month 30 Day

Last modified on

2020 Year 09 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047890


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name