Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration

NCT ID: NCT04022720

Last Updated: 2020-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-15

Study Completion Date

2020-08-03

Brief Summary

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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

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Conditions

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Mucosal Ulceration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Platelet Rich Fibrin (PRF) Group

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

Group Type EXPERIMENTAL

Platelet Rich Fibrin Application

Intervention Type PROCEDURE

Platelet Rich Fibrin application at first post-op visit.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Platelet Rich Fibrin Application

Platelet Rich Fibrin application at first post-op visit.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salam Salman, MD, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

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IRB201901614

Identifier Type: -

Identifier Source: org_study_id

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