Back to resultsPlatelet-Rich Fibrin in Intraoral Soft Tissue Regeneration
Primary Purpose
Mucosal Ulceration
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Platelet Rich Fibrin Application
Sponsored by
About this trial
This is an interventional treatment trial for Mucosal Ulceration focused on measuring platelet rich fibrin (PRF)
Eligibility Criteria
Inclusion Criteria:
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.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Platelet Rich Fibrin (PRF) Group
No Platelet Rich Fibrin Group
Arm Description
Patients randomized to this group will receive treatment with a PRF graft.
Participants in the observational control group will be managed at the time of the complication by standard of care methods.
Outcomes
Primary Outcome Measures
Change in rate of healing in intraoral mucosa and epithelium soft tissues
Improved healing times of PRF patients compared to control group.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04022720
Brief Title
Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration
Official Title
Role of Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration of Head and Neck Surgery Patients: A Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No patients enrolled. Also, impacted of COVID on enrolling subjects hindered recruitment.
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
August 3, 2020 (Actual)
Study Completion Date
August 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucosal Ulceration
Keywords
platelet rich fibrin (PRF)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet Rich Fibrin (PRF) Group
Arm Type
Experimental
Arm Description
Patients randomized to this group will receive treatment with a PRF graft.
Arm Title
No Platelet Rich Fibrin Group
Arm Type
No Intervention
Arm Description
Participants in the observational control group will be managed at the time of the complication by standard of care methods.
Intervention Type
Procedure
Intervention Name(s)
Platelet Rich Fibrin Application
Intervention Description
Platelet Rich Fibrin application at first post-op visit.
Primary Outcome Measure Information:
Title
Change in rate of healing in intraoral mucosa and epithelium soft tissues
Description
Improved healing times of PRF patients compared to control group.
Time Frame
3 months post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salam Salman, MD, DDS
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared with other researchers
Learn more about this trial
Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration
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