Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration

Not Applicable

Withdrawn

• Conditions: Mucosal Ulceration
• Interventions: Procedure: Platelet Rich Fibrin Application

• Registration Number: NCT04022720
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-17
• Study Start: 2019-09-15
• Status Verified: 2020-08
• Primary Completion: 2020-08-03
• Study Completion: 2020-08-03
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet Rich Fibrin (PRF) Group	Platelet Rich Fibrin Application	Patients randomized to this group will receive treatment with a PRF graft.

Primary Outcome Measures

Name	Time	Method
Change in rate of healing in intraoral mucosa and epithelium soft tissues	3 months post-operatively	Improved healing times of PRF patients compared to control group.