UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055540 |
|---|---|
| Receipt number | R000062008 |
| Scientific Title | Effect of alar base cinch suture and/or splint with nose morphology following Orthognathic Surgery |
| Date of disclosure of the study information | 2024/09/19 |
| Last modified on | 2024/09/19 16:26:59 |
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Basic information
Public title
Effect of alar base cinch suture and/or splint with nose morphology following Orthognathic Surgery
Acronym
Effect of alar base cinch suture and/or splint with nose morphology following Orthognathic Surgery
Scientific Title
Effect of alar base cinch suture and/or splint with nose morphology following Orthognathic Surgery
Scientific Title:Acronym
Effect of alar base cinch suture and/or splint with nose morphology following Orthognathic Surgery
Region
| Japan |
Condition
Condition
Jaw deformity
Classification by specialty
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify changes in the morphology of the nose and the inhibitory effect of the splint following orthognathic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
nasal alar width,nasal height
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
with a splint
Interventions/Control_2
without splint
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Participants who agreed with the study purpose and experimental procedures of this study.
2. Participants who have consented to participate in this study.
3. Participants who have signed an informed consent form.
Key exclusion criteria
1.Patients with hemorrhagic predisposition
2.Patients with postoperative factor 13 deficiency
3.Postoperative infection
4.Patients with SSRO only
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Hasegawa |
Organization
School of Dentistry, Aichi Gakuin University Graduate School of Medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
464-8651
Address
2-11, Suemori-Dori, Chikusa-ku, Nagoya 464-8651, Japan
TEL
052-759-2160
shogo@dpc.aichi-gakuin.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Hasegawa |
Organization
School of Dentistry, Aichi Gakuin University Graduate School of Medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
464-8651
Address
2-11, Suemori-Dori, Chikusa-ku, Nagoya 464-8651, Japan
TEL
052-759-2160
Homepage URL
shogo@dpc.aichi-gakuin.ac.jp
Sponsor or person
Institute
School of Dentistry, Aichi Gakuin University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
School of Dentistry, Aichi Gakuin University Graduate School of Medicine
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
School of Dentistry, Aichi Gakuin University Graduate School of Medicine
Address
2-11, Suemori-Dori, Chikusa-ku, Nagoya 464-8651, Japan
Tel
052-759-2160
shogo@dpc.aichi-gakuin.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
| 2024 | Year | 09 | Month | 19 | 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 | 04 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 27 | 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
Management information
Registered date
| 2024 | Year | 09 | Month | 19 | Day |
Last modified on
| 2024 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062008
