Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration

NCT04022720 | Withdrawn

• 1 other identifier: IRB201901614
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mucosal Ulceration

Keywords

platelet rich fibrin (PRF)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Platelet Rich Fibrin (PRF) Group

EXPERIMENTAL

Patients randomized to this group will receive treatment with a PRF graft.

Procedure: Platelet Rich Fibrin Application

No Platelet Rich Fibrin Group

NO INTERVENTION

Participants in the observational control group will be managed at the time of the complication by standard of care methods.

Interventions

Platelet Rich Fibrin Application PROCEDURE

Platelet Rich Fibrin application at first post-op visit.

Platelet Rich Fibrin (PRF) Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Officials

• Salam Salman, MD, DDS

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 17, 2019
• Study Start: September 15, 2019
• Primary Completion: August 3, 2020
• Study Completion: August 3, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share