UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003704 |
|---|---|
| Receipt number | R000004445 |
| Scientific Title | Clinical study on usefulness of PGA and fibrin glue covering for oral mucosal defect |
| Date of disclosure of the study information | 2010/06/05 |
| Last modified on | 2010/06/03 19:45:45 |
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Basic information
Public title
Clinical study on usefulness of PGA and fibrin glue covering for oral mucosal defect
Acronym
covering method with PGA for oral mucosal defect
Scientific Title
Clinical study on usefulness of PGA and fibrin glue covering for oral mucosal defect
Scientific Title:Acronym
covering method with PGA for oral mucosal defect
Region
| Japan |
Condition
Condition
oral mucosal defect
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clinical study on usefulness of this method
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.No adverse event with use material.
2.The material have better or same function in comparison with skin graft.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Covering method for 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Meet all of the following requirements
1,A patient who agree with the cooperation of the study.
2,The material used the study can use for the patient.
3.The case which need covering of oral mucosal defect.
Key exclusion criteria
1,A patient who do not agree with the cooperation of the study.
2,The material used in the study is contraindicated in the patient.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | KURITA HIROSHI |
Organization
Shinshu University,School of Medicine
Division name
Department of Dentistry and Oral Surgery
Zip code
Address
1-1-3Asahi,Matsumoto-city Nagano,Japan
TEL
0263-37-2677
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KURITA HIROSHI |
Organization
Shinshu University,School of Medicine
Division name
Department of Dentistry and Oral Surgery
Zip code
Address
1-1-3Asahi,Matsumoto-city Nagano,Japan
TEL
0263-37-2677
Homepage URL
Sponsor or person
Institute
Shinshu University,School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Dentistry and Oral Surgery,Shinshu University,School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | Year | 06 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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
| 2010 | Year | 06 | Month | 03 | Day |
Last modified on
| 2010 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004445
