UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022479 |
|---|---|
| Receipt number | R000025900 |
| Scientific Title | Efficacy of platelet rich fibrin (PRF)for the prevention and the treatment of Medication Related Osteonecrosis of the Jaw(MRONJ) |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/02/10 14:00:06 |
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Basic information
Public title
Efficacy of platelet rich fibrin (PRF)for the prevention and the treatment of Medication Related Osteonecrosis of the Jaw(MRONJ)
Acronym
Efficacy of PRF for prevention/treatment of MRONJ
Scientific Title
Efficacy of platelet rich fibrin (PRF)for the prevention and the treatment of Medication Related Osteonecrosis of the Jaw(MRONJ)
Scientific Title:Acronym
Efficacy of PRF for prevention/treatment of MRONJ
Region
| Japan |
Condition
Condition
Medication Related Osteonecrosis of the Jaw
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish preventive method and surgecal management protocol for medication related osteonectoris of the jaw.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of bone exposure. (For preventive and surgical treatment studies, the result will be evaluated at three and twelve months after surgery, respectively).
Key secondary outcomes
Presence of inflammation
Presence and level of pain
Presence of pus discharge
Presence of external fistula
(For preventive and surgical treatment studies, the result will be evaluated at three and twelve months after surgery, respectively).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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
| Other |
Interventions/Control_1
PRF is placed at bone exposure area and the wound will be closed with a nylon suture.
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
1. Preventive treatment protocol
Patients, who subscribed medications which affect bone metabolism, for the treatment of malignant tumor (ex. bisphosphonate, anti-RANKL ab) but not having MRONJ and need to have an oral surgery (ex. tooth extraction).
Age 20 or older.
Patients with good oral hygene.
Patients who can obtain written informed consent.
2. Surgical treatment protocol
MRONJ patients who require surgical treatment (ex. removal of necrotic bone).
Diagnosis of MRONJ should be based on the position paper by AAMOS (2014) as follows:
(Definition:
Patients may be considered to have MRONJ if all of the following characteristics are present:
1. Current or previous treatment with antiresorptive or antiangiogenic agents;
2. Exposed bone or bone that can be probed through an intraoral or extraoral fistula(e) in the maxillofacial region that has persisted for more than eight weeks; and
3. No history of radiation therapy to the jaws or obvious metastatic disease to the jaws.)
Age 20 or older.
Patients with good oral hygene.
Patients who can obtain written informed consent.
Key exclusion criteria
Patients with serious endocrine metabolic diseases and autoimmune diseases.
Patients with sepsis or potential sepsis.
Patients with hematologic diseases, blood disorders, blood coagulation disorders and liver diseases and having difficulty of transplantation.
Positive for any of syphilis, HBV antibody, HCV antibody, HIV antibody and HTLV-1 antibody.
Patients with transmissible spongiform encephalopathy, potent transmissible spongiform encephalopathy or dementia.
Patients with genetic diseases including sclerosing lesion of bone.
Any other conditions that the dentists in charge consider inappropriate.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Kagami |
Organization
Matsumoto Dental University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
1780 Gobara, Hirooka, Shiojiri, Nagano, 399-0781 Japan
TEL
0263-51-2066
hideaki.kagami@mdu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Kagami |
Organization
Matsumoto Dental University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
1780 Gobara, Hirooka, Shiojiri, Nagano, 399-0781 Japan
TEL
0263-51-2066
Homepage URL
hideaki.kagami@mdu.ac.jp
Sponsor or person
Institute
Matsumoto Dental University
Institute
Department
Personal name
Funding Source
Organization
Matsumoto Dental University
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
| 2016 | Year | 06 | 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
So far, two patients were enrolled in this clinical study and PRF was administered sumultaneously at the time of necrotic bone removal (preventive purpose). In both patients, the region was healed and no recurrence was observed during the observation period.
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
Terminated
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 26 | Day |
Last modified on
| 2019 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025900
