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Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration

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University of Florida

Status

Withdrawn

Conditions

Mucosal Ulceration

Treatments

Procedure: Platelet Rich Fibrin Application

Study type

Interventional

Funder types

Other

Identifiers

NCT04022720
IRB201901614

Details and patient eligibility

About

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

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Platelet Rich Fibrin (PRF) Group
Experimental group
Description:
Patients randomized to this group will receive treatment with a PRF graft.
Treatment:
Procedure: Platelet Rich Fibrin Application
No Platelet Rich Fibrin Group
No Intervention group
Description:
Participants in the observational control group will be managed at the time of the complication by standard of care methods.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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