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Clinical Trials/NCT04022720
NCT04022720
Withdrawn
N/A

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

University of Florida0 sitesSeptember 15, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mucosal Ulceration
Sponsor
University of Florida
Primary Endpoint
Change in rate of healing in intraoral mucosa and epithelium soft tissues
Status
Withdrawn
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2019
End Date
August 3, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Three categories of patients will be included in this study:
  • Osteoradionecrosis (ORN) or medication related osteonecrosis of the jaw (MRONJ) patients who present to clinic with exposed bone and no clinical sign of infection.
  • 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.
  • 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.

Outcomes

Primary Outcomes

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.

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