Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration NCT04022720

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Withdrawn

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

Recruitment information / eligibility
Status	Withdrawn
Enrollment	0
Est. completion date	August 3, 2020
Est. primary completion date	August 3, 2020
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	18 Years to 100 Years
Eligibility	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.

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

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
University of Florida

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Change in rate of healing in intraoral mucosa and epithelium soft tissues	Improved healing times of PRF patients compared to control group.	3 months post-operatively