UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010239 |
|---|---|
| Receipt number | R000011962 |
| Scientific Title | Estimation of platelet-rich fibrin on prevention of bisphosphonate-related osteonecrosis of the jaw |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2015/05/12 11:29:49 |
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Basic information
Public title
Estimation of platelet-rich fibrin on prevention of bisphosphonate-related osteonecrosis of the jaw
Acronym
Estimation of platelet-rich fibrin on prevention of bisphosphonate-related osteonecrosis of the jaw
Scientific Title
Estimation of platelet-rich fibrin on prevention of bisphosphonate-related osteonecrosis of the jaw
Scientific Title:Acronym
Estimation of platelet-rich fibrin on prevention of bisphosphonate-related osteonecrosis of the jaw
Region
| Japan |
Condition
Condition
bisphosphonate-related osteonecrosis of the jaw
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of platelet-rich fibrin on wound healing and bone regeneration of tooth extraction in a patient receiving oral bisphosphonate therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
percentage of the cases without impaired healing of socket
The incidence of adverse event
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
| Maneuver | Other |
Interventions/Control_1
A total of 10 subjects,3 months study.
a patientreceiving oral bisphosphonate therapy for not less than 1 year.
platelet-fibrin is separated from blood and plugged into extraction socket.
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
a patient receiving oral bisphosphonate therapy for not less than 1 year.
a patient who needs to extract teeth
Key exclusion criteria
poor general condition
a patients who is difficult to visit our hospital for 3 months after tooth extraction.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Asaka |
Organization
Hokkaido University
Division name
Graduate School of Dental Medicine
Zip code
Address
Kita-13, Nishi-7, Kita-ku, Sapporo 060-8586
TEL
011-706-4280
asakatakuya@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Asaka |
Organization
Hokkaido University
Division name
Graduate School of Dental Medicine
Zip code
Address
Kita-13, Nishi-7, Kita-ku, Sapporo 060-8586
TEL
011-706-4280
Homepage URL
asakatakuya@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 13 | Day |
Last modified on
| 2015 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011962
