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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003704
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Shinshu University,School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004445

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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