The Primary Objectives of the present study are : - To Evaluate the effect of platelet rich fibrin matrix (PRFM) and peripheral blood mesenchymal stem cells (PBMSCs) on implant stability. - To Compare the effect of platelet rich fibrin matrix (PRFM) alone to peripheral blood mesenchymal stem cells (PBMSCs) embedded in platelet rich fibrin matrix (PRFM) on implant stability.

Brief Title

The Effect of Platelet Rich Fibrin Matrix With and Without Peripheral Blood Mesenchymal Stem Cells on Implant Stability

Official Title

A Comparative Evaluation of the Effect of Platelet Rich Fibrin Matrix With and Without Peripheral Blood Mesenchymal Stem Cells on Implant Stability : A Randomized Controlled Clinical Trial

Brief Summary

The Primary Objectives of the present study are :<br /><br /> - To Evaluate the effect of platelet rich fibrin matrix (PRFM) and peripheral blood<br /> mesenchymal stem cells (PBMSCs) on implant stability.<br /><br /> - To Compare the effect of platelet rich fibrin matrix (PRFM) alone to peripheral blood<br /> mesenchymal stem cells (PBMSCs) embedded in platelet rich fibrin matrix (PRFM) on<br /> implant stability.

Detailed Description

The addition of molecules or growth factors to the implant surface is an approach to enhance
bone to implant contact (BIC).1 Platelet rich fibrin matrix (PRFM) is an autologous
concentrated platelet-rich thrombin free fibrin matrix, prepared by two step centrifugation
of blood. 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.2 During the second spin, a cross-linking of fibrin takes place, resulting in the
formation of a dense fibrin matrix, within which a concentration of viable platelets can be
found. Having an organized fibrin matrix at the start of healing accelerates the speed of
vascular ingress into the wound compared to non-accelerated healing, which requires a longer
time for fibrin formation and the development of vascularity. The earlier the vascularity is
established, faster is the migration of the bone-forming cells at the wound site and
initiation of bone formation. Therapeutic applications of platelet-rich products have led to
improved bone regeneration and faster titanium implant osseointegration, which improve the
stability and maintenance of dental implants by increasing BIC.1 Mesenchymal stem cells
(MSCs) is a multipotent stromal cell with prominent regenerative functions. MSCs were first
identified and isolated from bone marrow and then found in various tissues including
umbilical cord, adipose tissue and peripheral blood. Among these sources peripheral blood
MSCs draw increasing attention as they share similar biological characteristics with MSCs
derived from bone marrow or adipose tissue. Bone marrow derived mesenchymal stem
cells(BMMSCs) are multipotent cells capable of differentiating into osteoblasts,
chondrocytes, adipocytes , fibroblasts, tenocytes, and myoblasts , which are considered as a
cell source for various tissue repair and regenerating bone defects.3 The requirements of
aspiration of bone marrow from the patient will cause pain and morbidity of the donor sites.
It will be very convenient if peripheral blood mesenchymal stem cells (PBMSCs) could be
harvested and expanded to enough numbers, with their osteogenic capacity maintained in a
clinical permitted period.

The literature search does not show any human clinical trial conducted till date to assess
the regenerative potential of this new modality i.e. PRFM and peripheral blood mesenchymal
stem cells. This study therefore aims at the evaluation of PRFM and PBMSCs as regenerative
materials for implant stability.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.