Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration

Overview

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

Full Title of Study: “Role of Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration of Head and Neck Surgery Patients: A Prospective Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 3, 2020

Interventions

  • Procedure: Platelet Rich Fibrin Application
    • Platelet Rich Fibrin application at first post-op visit.

Arms, Groups and Cohorts

  • Experimental: Platelet Rich Fibrin (PRF) Group
    • Patients randomized to this group will receive treatment with a PRF graft.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Florida
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Salam Salman, MD, DDS, Principal Investigator, University of Florida

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