UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047178 |
|---|---|
| Receipt number | R000053809 |
| Scientific Title | Evaluation of oral function for patients with oral and maxillofacial disorders |
| Date of disclosure of the study information | 2022/03/18 |
| Last modified on | 2022/03/15 17:53:23 |
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Basic information
Public title
Evaluation of oral function for patients with oral and maxillofacial disorders
Acronym
Evaluation of oral function for patients with oral and maxillofacial disorders
Scientific Title
Evaluation of oral function for patients with oral and maxillofacial disorders
Scientific Title:Acronym
Evaluation of oral function for patients with oral and maxillofacial disorders
Region
| Japan |
Condition
Condition
Oral and maxillofacial disease
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish an individualized treatment strategy for oral reconstruction using the patient's postoperative function as an index.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of postoperative oral function
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
Patients who have lost their jawbone or teeth due to a disease in the maxillofacial region, or who are scheduled for surgery with loss of their jawbone and teeth.
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Miyashsita |
Organization
Keio University
Division name
Division of Dentistry and Oral Surgery, Department of Dentistry and Oral Surgery
Zip code
160-85852
Address
35 Shinanomachi Shinjykuku Tokyo
TEL
03-3353-1211
miyashita@z2.keio.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Munakata |
Organization
Keio University
Division name
Division of Dentistry and Oral Surgery, Department of Dentistry and Oral Surgery
Zip code
160-85852
Address
35 Shinanomachi Shinjykuku Tokyo
TEL
03-3353-1211
Homepage URL
munakatakanako@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
none
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
Keio University
Address
35 Shinanomachi Shinjykuku Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2022 | Year | 03 | Month | 18 | 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
| 2021 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will review masticatory function tests and QOL surveys performed on patients in need of oral reconstructive treatment, and quantitatively analyze the effects of standard reconstructive treatment on oral function and QOL.
Management information
Registered date
| 2022 | Year | 03 | Month | 15 | Day |
Last modified on
| 2022 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053809
