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Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration

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ClinicalTrials.gov Identifier: NCT04022720
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Determine if the use of platelet rich fibrin (PRF) improves the rate and quality of healing for intraoral mucosal and epithelial soft tissue defects.

Condition or disease Intervention/treatment Phase
Mucosal Ulceration Procedure: Platelet Rich Fibrin Application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration of Head and Neck Surgery Patients: A Prospective Clinical Trial
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Platelet Rich Fibrin (PRF) Group
Patients randomized to this group will receive treatment with a PRF graft.
Procedure: Platelet Rich Fibrin Application
Platelet Rich Fibrin application at first post-op visit.

No Intervention: 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.



Primary Outcome Measures :
  1. Change in rate of healing in intraoral mucosa and epithelium soft tissues [ Time Frame: 3 months post-operatively ]
    Improved healing times of PRF patients compared to control group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Three categories of patients will be included in this study:

    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:

  • Patients under 18 years of age.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022720


Contacts
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Contact: Salam Salman, MD, DDS 904-244-3901 salam.salman@jax.ufl.edu
Contact: Stacy Smith 904-244-3884 stacy.smith@jax.ufl.edu

Locations
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United States, Florida
UF Health Jacksonville
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Salam Salman, MD, DDS University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04022720     History of Changes
Other Study ID Numbers: IRB201901614
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
platelet rich fibrin (PRF)

Additional relevant MeSH terms:
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Ulcer
Pathologic Processes