UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000010239
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email asakatakuya@den.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

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
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 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011962

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.