Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration
NCT ID: NCT04022720
Last Updated: 2020-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-09-15
2020-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Platelet Rich Fibrin (PRF) Group
Patients randomized to this group will receive treatment with a PRF graft.
Platelet Rich Fibrin Application
Platelet Rich Fibrin application at first post-op visit.
No Platelet Rich Fibrin Group
Participants in the observational control group will be managed at the time of the complication by standard of care methods.
No interventions assigned to this group
Interventions
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Platelet Rich Fibrin Application
Platelet Rich Fibrin application at first post-op visit.
Eligibility Criteria
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Inclusion Criteria
1. Osteoradionecrosis (ORN) or medication related osteonecrosis of the jaw (MRONJ) patients who present to clinic with exposed bone and no clinical sign of infection.
2. Patients having an excisional biopsy in clinic performed under local anesthesia resulting in a defect that cannot be easily repaired without compromising normal anatomy or function. These situations include excisions which would result in primary closure under tension or with distorted anatomy, require a local flap, or require healing by secondary intention.
3. Patients presenting to the post-operative clinic with intraoral surgical wound dehiscence or an intraoral surgical wound healing by secondary intention.
Exclusion Criteria
* Patient's unable to participate in blood draw either due to medical compromise, inability to tolerate the procedure, or inability of the physician to successfully draw the blood at the time of appointment.
18 Years
100 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Salam Salman, MD, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Other Identifiers
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IRB201901614
Identifier Type: -
Identifier Source: org_study_id
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