Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03616925 |
| Other study ID # |
KLESociety |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
September 2013 |
| Est. completion date |
November 2014 |
Study information
| Verified date |
August 2018 |
| Source |
KLE Society's Institute of Dental Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Periodontitis is a chronic inflammatory disease caused by bacterial Plaque, the onset and
progression of which is modulated by a variety of risk factors such as systemic conditions
and smoking. It causes pathological alterations of the periodontium, resulting in loss of
connective tissue attachment to the tooth, apical migration of the junctional epithelium
along the root surface and loss of supporting alveolar bone. If left untreated, cases of
periodontal disease can lead to premature tooth loss. However, the complex structure of
periodontium, which consist of soft connective tissue of gingiva and periodontal ligament, as
well as the mineralized tissues, cementum and bone, makes periodontal wound healing a unique
process.
Although, all the tissues of the periodontium get affected, the crux of the problem of
chronic periodontal diseases lies in the changes that occur in the bone resulting in
intraosseous defects of various architecture, the persistence of which even after completion
of active periodontal treatment may increase the site-specific risk of progression of
periodontitis.
The two primary components of periodontal therapy involves, the elimination of the
periodontal infection by eliminating the pathogenic periodontal microflora which induces
favourable clinical changes in the periodontium and substantial efforts should be made to
alter the anatomic defect resulting from active periodontitis.
The resective surgical approach and mucogingival surgeries (MGS) were the major periodontal
therapies until the 1970s. However, problems with esthetics, root sensitivity and root caries
resulting from resective therapy for severe periodontitis were eventually pointed out. Also
resective procedure was admitted to be a "Repair" and not "Regeneration" which has long been
the goal of periodontal therapy. The past two decades has seen a radical change in
periodontal surgery with a shift from resective periodontal surgery to regenerative
therapies. Also the concept of treatment has changed towards regeneration with a goal of
regaining natural periodontal apparatus.
Conventional surgical approaches (e.g., flap debridement) continue to offer time-tested and
reliable methods to access root surfaces, reduce periodontal pockets and attain improved
periodontal form/architecture. However, these techniques offer only limited potential to
recover tissues, destroyed during earlier disease phases.
Broad ranges of treatment options are available, but only some are regarded as truly
regenerative procedures. Periodontal regeneration is a complex process which requires an
orchestrated sequence of biologic events, such as cell migration, adherence, growth, and
differentiation involving a large number of growth factors and cytokines for its
regulation.To accelerate clinical translation of the same, there is an ongoing need to
develop therapeutics based on endogenous regenerative technology (ERT), which can stimulate
latent self-repair mechanisms in patients and harness the host's innate capacity for
regeneration. ERT in periodontics applies the patient's own regenerative 'tools', that is,
patient-derived growth factors (GFs) and fibrin scaffolds, to create a material niche in an
injured site where the progenitor/stem cells from neighbouring tissues can be recruited for
(in situ) periodontal regeneration.
Growth factors are naturally occurring proteins that function in the body to promote the
mitogenesis (proliferation), directed migration and metabolic activity of cells. Numerous
growth factors have been identified, the expression of which following bone and soft tissue
injury may regulate the repair and regenerative process. Platelets apart from their role in
haemostasis have been reported to possess regenerative potential as their alpha granules are
rich sources of various vital growth factors. These growth factors such as platelet derived
growth factor, transforming growth factor β1, epithelial growth factor, vascular endothelial
growth factor, insulin like growth factor and fibroblast growth factor whether used alone or
in combination have been extensively studied and shown to promote the regeneration of oral
and maxillofacial bone defects. Platelet growth factors may initiate healing by attracting
undifferentiated cells within the fibrin matrix that is formed in the very early stages of
healing process and by triggering cell division.
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.
Currently several methods are available for PRP preparation, most producing a liquid end
product to promote tissue repair. Due to poor mechanical properties, conventional PRP is
often difficult to handle in clinical settings that require secure implantation in a specific
site or where released growth factors could be washed out during an operation. The physical
properties of PRP can be changed if plasma and platelets are stimulated by the addition of
calcium chloride and thrombin. The exogenous activation of platelets using bovine thrombin at
the time of PRP preparation result in an almost immediate degranulation and disintegration of
platelet granules. Consequently, complete growth factor release will take place at the time
of PRP preparation and placement. Since wound healing requires a sequential appearance of
vessels and cells over time, the immediate and almost complete release of platelet granules
may have very little beneficial effect on later stages of healing.
In contrast, 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.
