Mucosal UlcerationNCT04022720
Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration
A study testing Platelet Rich Fibrin Application in people with Mucosal Ulceration, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucosal Ulceration
- What is being tested?
- Platelet Rich Fibrin Application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2019to 3 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Role of Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration of Head and Neck Surgery Patients: A Prospective Clinical Trial
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
- Being tested
- Platelet Rich Fibrin Application
- Keywords
- platelet rich fibrin (PRF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Fibrin ApplicationProcedure or surgery
Platelet Rich Fibrin application at first post-op visit.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Fibrin (PRF) Group | Experimental | Patients randomized to this group will receive treatment with a PRF graft. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rate of healing in intraoral mucosa and epithelium soft tissues
Improved healing times of PRF patients compared to control group.
Measured: 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start15 Sep 2019
- Primary completion3 Aug 2020
- Study completion3 Aug 2020
Why it stopped: No patients enrolled. Also, impacted of COVID on enrolling subjects hindered recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal UlcerationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salam Salman, MD, DDS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022720
- Sponsor's protocol ID
- IRB201901614
- Status last verified
- Aug 2020
- First submitted
- 12 Jul 2019
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration of Head and Neck Surgery Patients: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04022720
- Acronym / sponsor ID
- IRB201901614
- Conditions
- Mucosal Ulceration
- Keywords
- platelet rich fibrin (PRF)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled. Also, impacted of COVID on enrolling subjects hindered recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine if the use of platelet rich fibrin (PRF) improves the rate and quality of healing for intraoral mucosal and epithelial soft tissue defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Fibrin (PRF) Group | Experimental | Procedure: Platelet Rich Fibrin ApplicationPatients randomized to this group will receive treatment with a PRF graft. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Three categories of patients will be included in this study:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich Fibrin ApplicationPlatelet Rich Fibrin application at first post-op visit. | Procedure or surgery | Platelet Rich Fibrin (PRF) Group |
Primary outcome
Change in rate of healing in intraoral mucosa and epithelium soft tissues
Time frame: 3 months post-operatively
Improved healing times of PRF patients compared to control group.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salam Salman, MD, DDS principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Fibrin Application in people with Mucosal Ulceration, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rate of healing in intraoral mucosa and epithelium soft tissues (time frame: 3 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.