UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044742
Receipt number R000051098
Scientific Title Elucidation of the impact of malocclusion and it's treatment on brain blood flow.
Date of disclosure of the study information 2021/07/03
Last modified on 2021/07/02 17:43:56

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Basic information

Public title

Elucidation of the impact of malocclusion and it's treatment on brain blood flow.

Acronym

Elucidation of the impact of malocclusion and it's treatment on brain blood flow.

Scientific Title

Elucidation of the impact of malocclusion and it's treatment on brain blood flow.

Scientific Title:Acronym

Elucidation of the impact of malocclusion and it's treatment on brain blood flow.

Region

Japan


Condition

Condition

Malocclusion (jaw deformity)

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Scientific literatures support the influence of occlusion on systemic health. In addition, relationship between occlusal rehabilitation and the status of the cognitive function
were reported.
Orthodontic treatment, especially surgical orthodontic treatment aims to correct the occlusal function, and research reports revealed the correction of the occlusal function by orthodontic treatment. However, there were no report whether orthodontic treatment give any impact on brain function at present.
In this research, we aim to compare the brain blood flow before and after orthodontic treatment, using functional Near-Infrared Spectroscopy. We also aim to reveal the correlation between the extent of brain blood flow and cognitive function.

Basic objectives2

Others

Basic objectives -Others

We compare the data between the normal occlusion group and malocclusion group, and elucidate whether there are any difference between the groups from the point of brain function.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

We measure the brain blood flow and cognitive function of the patient with malocclusion (jaw deformity), and analyze the relationship among occlusal function, brain blood flow, and cognitive function. In addition, to compare the before and after orthodontic treatment, we clarify whether orthodontic treatment give any improvement on brain blood flow and cognitive function or not.
In this research project, we assess; (1) cross-sectional study between normal occlusion group and malocclusion group, (2) cross-sectional study among the different time points in malocclusion group, (3) longitudinal study for elucidating the intra-patient change in brain blood flow and cognitive function.
We examine at the following time points;
(1) before orthodontic treatment
(2) before jaw surgery
(3) at debonding
(4) during maintenance period

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

surgical orthodontic treatment (treatment period: about 2.5-year)

Interventions/Control_2

no treatmen (normal occlusion)

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) no systemic illness
(2) no orthodontic treatment history
(3) no symptons on temporomandibular joint, masticatory muscles, and tooth
(4) Right-handed

Key exclusion criteria

(1) have congenital diseases
(2) have mental and psychological illness

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Kanzaki

Organization

Tsurumi University

Division name

Department of orthodontics School of Dental Medicine

Zip code

230-8501

Address

2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa pref., 230-8501, Japan

TEL

045-580-8507

Email

kanzaki-h@tsurumi-u.ac.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Kanzaki

Organization

Tsurumi University

Division name

Department of orthodontics School of Dental Medicine

Zip code

230-8501

Address

2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa pref., 230-8501, Japan

TEL

045-580-8507

Homepage URL


Email

kanzaki-h@tsurumi-u.ac.jp


Sponsor or person

Institute

Department of orthodontics
School of Dental Medicine
Tsurumi University

Institute

Department

Personal name



Funding Source

Organization

Tsurumi 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

Ethics Committee of Tsurumi University School of Dental Medicine

Address

2-1-3 Tsurumi, Tsurumi-ku, Yokohama,

Tel

045-580-8318

Email

kyoken@tsurumi-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

2021 Year 07 Month 03 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

Preinitiation

Date of protocol fixation

2021 Year 05 Month 12 Day

Date of IRB

2021 Year 06 Month 23 Day

Anticipated trial start date

2021 Year 07 Month 02 Day

Last follow-up date

2031 Year 07 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 07 Month 02 Day

Last modified on

2021 Year 07 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051098


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name