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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
