Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625528
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
The Present Study Was Performed to Evaluate the Efficacy of Lyophilized-PRF in Treatment of Periodontal Intra-bony Defects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy of Lyophilized Platelet-Rich Fibrin in Treatment of Periodontal Intra-Bony Defects A Comparative Clinical Radiographic and Biochemical Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study will be performed to evaluate the efficacy of lyophilized platelet-rich fibrin alone and combined with nanocrystalline hydroxyapatite in treatment of periodontal intra-bony defects through
1 Primary outcomes
The clinical parameters including Probing pocket depth PPD reduction and clinical attachment level CAL gain
The radiographic parameters including Marginal bone level MBL bone-defect fill
2 Secondary outcome The level of BMP-2 in Gingival crevicular fluid GCF
1 Primary outcomes
The clinical parameters including Probing pocket depth PPD reduction and clinical attachment level CAL gain
The radiographic parameters including Marginal bone level MBL bone-defect fill
2 Secondary outcome The level of BMP-2 in Gingival crevicular fluid GCF
Detailed Description:
Periodontitis is a multi-factorial inflammatory process affecting the periodontal tissues Among the characteristic signs of periodontal disease is loss of alveolar bone support The risk of further alveolar bone loss and the probability of tooth loss increases with the presence of intra-bony defects
Periodontal intra-bony defects IBDs are osseous defects with specific morphology the bottom of these defects is located more apically than the alveolar crest and they are surrounded by bony walls on 1- 2- or 3- sides with the tooth root forming the additional wall The prevalence of these defects is significantly lower than supra-crestal periodontal defects
Among the main goals of periodontal therapy is to regenerate the lost periodontal tissues after arresting the progress of the disease Surgical management of periodontally affected sites includes conventional and regenerative procedures The conventional modality of surgical debridement allows for reliable access to root surfaces leading only to healing by repair While the regenerative treatment options allow for the regeneration of destroyed periodontal ligament and bone Guided tissue regeneration GTR placement of bone grafting materials the addition of biologic mediators and a combination of such techniques are the different forms of periodontal regenerative techniques
Bone grafts BGs and substitutes are classified into autogenic allogenic xenogenic and synthetic bone grafts Synthetic nanocrystalline hydroxyapatite NCHA has been extensively applied as bone graft replacement material and characterized by its osteoconductive properties and improved osseointegrative features The size of the particle was found to be around 18 nm allowing for quicker vital bone substitution It has been proved that NCHA can enhance the adhesion of the bone formative cells osteoblasts more than micromaterials Furthermore the nano-sized particles provide special properties to NCHA such as ahydrated surface layer a large surfacevolume ratio this layer is actively involved in the homeostasis process ionic exchange and other techniques involved in the osteogenesis regulation NCHA is osteoconductive but has inferior osteoinductive properties therefore one of the efforts to increase the ability of this material is to combine it with other bioactive materials such as platelet-rich fibrin PRF
Platelet-rich fibrin is a second-generation platelet concentrate that has been widely used in the treatment of bone deficiency and its main action is derived from its high content of platelets that release many growth factors GFs and cytokines However freshly prepared PRF must be used immediately in order to retain the bioactivity of growth factors In addition the bio-degradation rate of PRF is fast and irregular along with the rapid release of growth factors and then enzymatically hydrolyzed
The lyophilization of PRF by vacuum freeze dryer was found to provide a dense three-dimensional fibrin network better storage stability with a longer half-life and preservation of GFs Lyophilized platelet-rich fibrin Ly-PRF showed adaptability as a viable biomaterial for application as a craniofacial bio-scaffold due to the advantage of lowering the difficulty in application providing a newly grown tissue with straightforward access to multiple GFs as well as sustained release GFs presenting a better tissue regeneration process and bone tissue reconstruction
It was proven that Ly-PRF significantly improve the osteogenic differentiation of bone marrow mesenchymal stem cell BMSC in vitro through the upregulation of osteogenic markers collagen type I osteopontin OPN osteocalcin OCN and bone morphogenetic protein 2 BMP-2 BMP-2 is described as being osteoinductive which is capable of inducing and enhancing bone growth and formation and it also promotes cell chemotaxis proliferation and differentiation towards the osteogenic pathway
The present clinical trial will be performed to clarify and shed some light on Ly-PRF in periodontal regeneration
Periodontal intra-bony defects IBDs are osseous defects with specific morphology the bottom of these defects is located more apically than the alveolar crest and they are surrounded by bony walls on 1- 2- or 3- sides with the tooth root forming the additional wall The prevalence of these defects is significantly lower than supra-crestal periodontal defects
Among the main goals of periodontal therapy is to regenerate the lost periodontal tissues after arresting the progress of the disease Surgical management of periodontally affected sites includes conventional and regenerative procedures The conventional modality of surgical debridement allows for reliable access to root surfaces leading only to healing by repair While the regenerative treatment options allow for the regeneration of destroyed periodontal ligament and bone Guided tissue regeneration GTR placement of bone grafting materials the addition of biologic mediators and a combination of such techniques are the different forms of periodontal regenerative techniques
Bone grafts BGs and substitutes are classified into autogenic allogenic xenogenic and synthetic bone grafts Synthetic nanocrystalline hydroxyapatite NCHA has been extensively applied as bone graft replacement material and characterized by its osteoconductive properties and improved osseointegrative features The size of the particle was found to be around 18 nm allowing for quicker vital bone substitution It has been proved that NCHA can enhance the adhesion of the bone formative cells osteoblasts more than micromaterials Furthermore the nano-sized particles provide special properties to NCHA such as ahydrated surface layer a large surfacevolume ratio this layer is actively involved in the homeostasis process ionic exchange and other techniques involved in the osteogenesis regulation NCHA is osteoconductive but has inferior osteoinductive properties therefore one of the efforts to increase the ability of this material is to combine it with other bioactive materials such as platelet-rich fibrin PRF
Platelet-rich fibrin is a second-generation platelet concentrate that has been widely used in the treatment of bone deficiency and its main action is derived from its high content of platelets that release many growth factors GFs and cytokines However freshly prepared PRF must be used immediately in order to retain the bioactivity of growth factors In addition the bio-degradation rate of PRF is fast and irregular along with the rapid release of growth factors and then enzymatically hydrolyzed
The lyophilization of PRF by vacuum freeze dryer was found to provide a dense three-dimensional fibrin network better storage stability with a longer half-life and preservation of GFs Lyophilized platelet-rich fibrin Ly-PRF showed adaptability as a viable biomaterial for application as a craniofacial bio-scaffold due to the advantage of lowering the difficulty in application providing a newly grown tissue with straightforward access to multiple GFs as well as sustained release GFs presenting a better tissue regeneration process and bone tissue reconstruction
It was proven that Ly-PRF significantly improve the osteogenic differentiation of bone marrow mesenchymal stem cell BMSC in vitro through the upregulation of osteogenic markers collagen type I osteopontin OPN osteocalcin OCN and bone morphogenetic protein 2 BMP-2 BMP-2 is described as being osteoinductive which is capable of inducing and enhancing bone growth and formation and it also promotes cell chemotaxis proliferation and differentiation towards the osteogenic pathway
The present clinical trial will be performed to clarify and shed some light on Ly-PRF in periodontal regeneration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None