UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038066 |
|---|---|
| Receipt number | R000043349 |
| Scientific Title | A study for masticatory muscle tendon-aponeurosis hyperplasia |
| Date of disclosure of the study information | 2021/12/23 |
| Last modified on | 2024/03/27 07:33:43 |
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Basic information
Public title
A study for masticatory muscle tendon-aponeurosis hyperplasia
Acronym
A study for masticatory muscle tendon-aponeurosis hyperplasia
Scientific Title
A study for masticatory muscle tendon-aponeurosis hyperplasia
Scientific Title:Acronym
A study for masticatory muscle tendon-aponeurosis hyperplasia
Region
| Japan |
Condition
Condition
masticatory muscle tendon-aponeurosis hyperplasia
Classification by specialty
| Oral surgery | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Elucidation for etiology of masticatory muscle tendon-aponeurosis hyperplasia
Basic objectives2
Others
Basic objectives -Others
Examination of molecules for the onset
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Identifying specific molecules for this disease
Key secondary outcomes
Examining gene mutation of this disease and analyzing the characteristics of this disease
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Elimination of whole of tendon tissue
Interventions/Control_2
Elimination of part of tendon tissue which is exposured
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. patients who are diagnosed as masticatory muscle tendon-aponeurosis hyperplasia
2. patients who underwent the operation of facial deformity
3. patients who underwent the operation of teeth extraction or removing jaw bone cysts
4. the second degree of kinship of patients who are diagnosed as masticatory muscle tendon-aponeurosis hyperplasia
Key exclusion criteria
patients except for key inclusion criteria
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sato |
| Middle name | |
| Last name | Tsuyoshi |
Organization
Saitama Medical University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
3500495
Address
38 Moro-hongou, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1859
tsato@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Sato |
| Middle name | |
| Last name | Tsuyoshi |
Organization
Saitama Medical University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
3500495
Address
38 Moro-hongou, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1859
Homepage URL
tsato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
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
Saitama Medical University institutional review board committee
Address
38 Moro-hongou, Moroyama-machi, Iruma-gun, Saitama
Tel
049-276-1354
hirb@saitama-med.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 | 12 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2019 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043349
