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Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration

Sponsor
University of Florida (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04022720
Collaborator
(none)
0
Enrollment
2
Arms
10.6
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Platelet Rich Fibrin Application
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Role of Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration of Head and Neck Surgery Patients: A Prospective Clinical Trial
Actual Study Start Date :
Sep 15, 2019
Actual Primary Completion Date :
Aug 3, 2020
Actual Study Completion Date :
Aug 3, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Platelet Rich Fibrin (PRF) Group

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

Procedure: Platelet Rich Fibrin Application
Platelet Rich Fibrin application at first post-op visit.
No Intervention: No Platelet Rich Fibrin Group

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Florida

Investigators

  • Principal Investigator: Salam Salman, MD, DDS, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT04022720
Other Study ID Numbers:
  • IRB201901614
First Posted:
Jul 17, 2019
Last Update Posted:
Aug 6, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Florida
platelet rich fibrin (PRF)
Additional relevant MeSH terms:
Ulcer

Study Results

No Results Posted as of Aug 6, 2020