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Ridge Preservation With Platelet Rich Fibrin Augmented With Freeze Dried Bone Allograft

NCT03043885 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-12-05

Study results available
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Summary

Improved predictability and quality of bone healing after a tooth is removed is clinically relevant, in that, it improves our ability to achieve successful implant placement at edentulous sites. Currently, a variety of grafting materials and biologic agents are utilized clinically to improve bone healing and provide sufficient dimensions of bone to support a dental implant. Platelet rich fibrin (PRF) is one such product that can be used for this application. PRF is a concentrated blood product attained from the patient's own blood consisting of a natural bioscaffold with integrated growth factors capable of sustained release. Once processed, PRF is implanted back into the patient at the wound or defect site to encourage healing. The literature regarding PRF is currently dominated by heterogeneous applications of PRF for reparative and regenerative therapies without a consensus of its clinical efficacy and appropriate application. In this clinical study, PRF will be evaluated to ascertain its clinical efficacy in improving bone formation and alveolar dimensional stability after tooth extraction. A classic bone grafting material used for this purpose, freeze dried bone allograft (FDBA), will be incorporated with the PRF or compared directly to PRF alone. It is hypothesized that the natural scaffold and incorporated growth factors of PRF augmented with the solubility resistance of FDBA will function as an ideal bioscaffold to promote bone healing to a greater extent compared to PRF, FDBA, or blood clot alone.

Conditions

  • Alveolar Ridge Preservation

Interventions

DEVICE

FDBA

Graft material used to graft extraction socket

DEVICE

PRF

Autologous blood product used to graft extraction socket

PROCEDURE

Blood Clot

Surgical treatment of extraction socket without addition of graft material

Sponsors & Collaborators

Principal Investigators

  • Mark Ryder, DDS · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-05
Primary Completion
2016-05-09
Completion
2017-03-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03043885 on ClinicalTrials.gov