UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005935 |
|---|---|
| Receipt number | R000006547 |
| Scientific Title | Transplantation of oral epithelial sheets cultivated on amniotic membrane for oral mucosal reconstruction. |
| Date of disclosure of the study information | 2011/07/06 |
| Last modified on | 2019/01/10 13:16:41 |
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Basic information
Public title
Transplantation of oral epithelial sheets cultivated on amniotic membrane for oral mucosal reconstruction.
Acronym
Transplantation of oral epithelial sheets cultivated on amniotic membrane for oral mucosal reconstruction.
Scientific Title
Transplantation of oral epithelial sheets cultivated on amniotic membrane for oral mucosal reconstruction.
Scientific Title:Acronym
Transplantation of oral epithelial sheets cultivated on amniotic membrane for oral mucosal reconstruction.
Region
| Japan |
Condition
Condition
The dental disorders that oral surgery, surgical prosthetic pre-treatment, periodontal surgery that produce an oral mucosal defect.
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the possibility of reconstructing the oral mucosal defect using autologous AM-cultivated oral epithelial cells.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We examined whether oral epithelial cells grown on AM would be effective as a biomaterial using for to the reconstruction of oral mucosa.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The dental disorders that oral surgery, surgical prosthetic pre-treatment, periodontal surgery that produce an oral mucosal defect.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo oral surgeries and that obtained agreement of research cooperation.
Key exclusion criteria
Intraoral malignant tumor disease patients.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Narisato KANAMURA |
Organization
Kyoto Prefectural University of Medicine
Division name
Dental Medicine, Graduate School of Medical Science
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5641
amemiya@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Amemiya |
Organization
Kyoto Prefectural University of Medicine
Division name
Dental Medicine, Graduate School of Medical Science
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5641
Homepage URL
amemiya@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Grant for Advanced Medical Treatment in Kyoto Prefectural University of Medicine, Grant-in-Aid for Scientific Research from Japan Society for the Promotion of Science.
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
Address
Tel
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
| 2011 | Year | 07 | Month | 06 | 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
Main results already published
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 06 | Day |
Last modified on
| 2019 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006547
