UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053349 |
|---|---|
| Receipt number | R000060895 |
| Scientific Title | Research on maxillofacial growth analysis and surgical indications in patients with Hemifacial microsomia |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2025/01/15 09:52:50 |
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Basic information
Public title
Research on facial and jaw growth analysis and the necessity of surgery in patients with Hemifacial microsomia
Acronym
Research on facial and jaw growth and surgical operations in patients with Hemifacial microsomia
Scientific Title
Research on maxillofacial growth analysis and surgical indications in patients with Hemifacial microsomia
Scientific Title:Acronym
Research on maxillofacial growth and surgical indications in patients with Hemifacial microsomia
Region
| Japan |
Condition
Condition
Hemifacial microsomia
Classification by specialty
| Oral surgery | Plastic surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By performing 3D morphological analysis through longitudinal examination of the maxillofacial area of patients with Hemifacial microsomia, we can predict the maxillofacial growth and determine the suitability of orthopedic orthodontic treatment and orthognathic surgery, and plan treatment according to the maxillofacial growth of each individual patient.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maxillofacial morphology after growth of treated patients
Key secondary outcomes
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
1. With pre-treatment X-ray examination data
2. Who had not been treated before X-ray examination
Key exclusion criteria
1. Without pre-treatment X-ray examination data
2. Who had been treated before X-ray examination
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yorikatsu |
| Middle name | |
| Last name | Watanabe |
Organization
Tokyo Metropolitan Police Hospital
Division name
Department of Plastic, Reconstructive & Aesthetic Surgery
Zip code
1648541
Address
4-22-1 Nakano, Nakano-ku, Tokyo
TEL
0353435611
yorika2@hotmail.com
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Yorozuya |
Organization
Incorporated Medical Institution, Yorozuya Dental Office
Division name
Division of Orthodontics
Zip code
1070062
Address
Shin-Aoyama Building, Building West 3rd floor, 1-1-1, Minami-Aoyama, Minato-ku, Tokyo
TEL
0334751888
Homepage URL
ryorozuya0827@gmail.com
Sponsor or person
Institute
Incorporated Medical Institution, Yorozuya Dental Office
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Plastic, Reconstructive & Aesthetic Surgery, Tokyo Metropolitan Police Hospital, Department of Oral and Maxillofacial Surgery, Tokyo Women's Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
An Institutional Review Board in Tokyo Metropolitan Police Hospital
Address
4-22-1 Nakano, Nakano-ku, Tokyo
Tel
0353435611
yakuzai@keisatsubyoin.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
23-A11
Org. issuing International ID_1
An Institutional Review Board in Tokyo Metropolitan Police Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 15 | 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
| 2023 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is because we have experienced in clinical treatment that the optimal timing for orthodontic treatment and plastic surgery treatment for maxillofacial asymmetry in patients with Hemifacial microsomia differs for each patient. The currently commonly used classification of the craniofacial morphology of patients with branchial arch syndrome is limited to two-dimensional evaluations. However, from the results of the current our analysis, we have discovered new three-dimensional taxonomic characteristics, which we have published as a paper in the Journal of the Plastic and Reconstructive Surgery Global Open (May 2024) and also presented as a symposium at the 16th World Congress of the International Cleft Lip and Palate Foundation (July 2024).
Management information
Registered date
| 2024 | Year | 01 | Month | 15 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060895
