UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057479 |
|---|---|
| Receipt number | R000065669 |
| Scientific Title | A study of changes in cognitive function due to changes in facial appearance associated with orthognathic surgery |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/04/01 14:09:04 |
* 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
A study of changes in cognitive function due to changes in facial appearance associated with orthognathic surgery
Acronym
A study of changes in cognitive function due to changes in facial appearance associated with orthognathic surgery
Scientific Title
A study of changes in cognitive function due to changes in facial appearance associated with orthognathic surgery
Scientific Title:Acronym
A study of changes in cognitive function due to changes in facial appearance associated with orthognathic surgery
Region
| Japan |
Condition
Condition
Jaw deformity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the chronological changes in the tendency towards dysmorphophobia due to improvements in facial appearance from the perspective of cognitive function, using 60 patients with jaw deformities and 60 control subjects. There is great significance in empirically obtaining findings on the effects of a certain sample size, and these findings could be useful for discovering patients' latent diseases and developing treatment programs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Assessment of Body Image Concern Inventory and Liebowitz Social Anxiety Scale are measured.
Key secondary outcomes
Gaze measurement and Galvanic skin response are measured.
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who are scheduled to undergo surgery for jaw deformity (excluding those who have undergone re-surgery).
Those who do not have any craniofacial disorders other than jaw deformity.
Those who do not have a history of mental illness.
Men and women aged 18 to 49.
Key exclusion criteria
Those who have had eye diseases such as cataracts, infections, injuries, or strabismus in the past six months.
Those with significant vision loss (myopia or astigmatism) and a corrected visual acuity of 0.7 or less.
Those who have had LASIK or ICL (surgery to implant an intraocular contact lens) in the past.
Those who are judged by researchers to be unable to participate.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shugo |
| Middle name | |
| Last name | Haga |
Organization
Showa medical university school of dentistry Department of Orthodontics
Division name
Department of Orthodontics
Zip code
145-8515
Address
2-1-1 kitasenzoku,Ota-ku,Tokyo 145-8515, JAPAN
TEL
262
shaga@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiki |
| Middle name | |
| Last name | Matsuzawa |
Organization
Showa medical university school of dentistry Department of Orthodontics
Division name
Department of Orthodontics
Zip code
145-8515
Address
2-1-1 kitasenzoku,Ota-ku,Tokyo 145-8515, JAPAN
TEL
262
Homepage URL
k-matsuzawa@dent.showa-u.ac.jp
Sponsor or person
Institute
Showa university
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SHOWA Medical University Research Ethics Review Board
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555 Japan
Tel
03-3784-8129
m-rinri@ofc.showa-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
| 2025 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study examines the relationship between mental illness factors (body dysmorphic disorder, social anxiety disorder) and cognitive function factors(eye movement measurement, skin perspiration measurement).
Management information
Registered date
| 2025 | Year | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065669
