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Evaluation of Platelet Rich Fibrin Matrix as Regenerative Material in Intraosseous Defects

NCT03616925 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-06

No results posted yet for this study

Summary

Technological advancement has led to the development of concentrated platelets, by means of centrifugation, popularly known as Platelet concentrates which seem to be a convenient approach to obtain autologous growth factors. Locally delivered platelet concentrates are supposed to increase the proliferation of connective tissue progenitors to stimulate fibroblast and osteoblast activity and enhance angiogenesis, all of which are fundamental to tissue healing and regeneration. Several techniques for platelet concentrates are available, each method leading to a different product with different biology and potential use. Different platelet concentrates are classified, depending on their leucocyte and fibrin content. Conventional platelet rich plasma (PRP), also known as first generation platelet concentrate is plasma with a platelet concentration above the normal physiologic levels found in blood.

Platelet Rich Fibrin Matrix (PRFM) is an autologous biologic material created by two step centrifugation of whole blood without the use of exogenous thrombin. Platelets isolated, remain intact and retain their growth factor compliment. This allows a more effective, sustained release of growth factors to the wound site following PRFM application. PRFM possesses the ability to enhance tissue repair by isolation, concentration and preservation of autologous platelets in a dense scaffold like fibrin matrix. The viable platelets contain intrinsic growth factors which are probably released in a desired spatial and temporal manner that affect every aspect of soft tissue and osseous healing.

Very limited studies have been conducted to assess the regenerative potential of this new modality i.e. PRFM. This study therefore aims at the evaluation of platelet rich fibrin matrix as a potential regenerative material in comparison with open flap debridement in human periodontal intraosseous defects.

Conditions

  • Regenerative Inflammation

Interventions

BIOLOGICAL

Platelet Rich Fibrin Matrix kit

Platelet Rich Fibrin Matrix kit was used to procure platelet rich fibrin matrix using centrifugation machine

PROCEDURE

surgical open flap debridement

only surgical open flap debridement was done without use of Platelet Rich Fibrin Matrix kit

Sponsors & Collaborators

  • KLE Society's Institute of Dental Sciences

    lead OTHER

Principal Investigators

  • Komal D Walia, MDS · KLE Society's Institute of Dental Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-09-30
Completion
2014-11-30
FDA Drug
Yes

Countries

  • India

Study Locations

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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 NCT03616925 on ClinicalTrials.gov