Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374784
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-16
Brief Title:
Autogenous Demineralized Dentin Graft Combined With Injectable PRF Metronidazole Versus Autogenous Demineralized Dentin Graft Combined With Injectable PRF Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
The Effect of Autogenous Demineralized Dentin Graft Combined With Injectable PRF Loaded With Metronidazole Versus Autogenous Demineralized Dentin Graft Combined With Injectable PRF Versus Autogenous Demineralized Dentin Graft Alone on Alveolar Ridge Preservation of Infected Sockets A Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this trial is to compare the effect of autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole sticky demineralized tooth releasing metronidazole versus autogenous demineralized dentin graft combined with injectable PRF sticky demineralized tooth versus autogenous demineralized dentin graft ADDG alone on alveolar ridge preservation after extraction of non restorable infected single-rooted teeth
Detailed Description:
Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction During the last decade efforts have been made to confirm procedures that can prevent bone resorption after extraction The use of bone grafts aim to promote bone healing and assist bone regeneration Various types of materials are used for socket preservation such as autogenous bone allograft bone xenograft materials and alloplast materials
Dentin contains several growth factors including transforming growth factor beta TGF-β insulin-like growth factor-II IGF-II and bone morphogenetic protein-2 BMP-2 which could be of pivotal importance during any healing event Demineralization of dentin has been further proposed to expose its collagen matrix liberate and fossilized growth factors and thereby enhance its regenerative capacity
It has been proven that autogenous demineralized dentin graft is effective at reducing dimensional losses of alveolar sockets after 6 months with no adverse effects
The efficacy of platelet rich fibrin PRF in promoting wound healing and tissue regeneration is at the center of a recent academic debate The liquid fibrinogen has been shown to bind particulate bone grafts which are then called sticky bon This binding improves the stabilization of the particles in the defect It adds a potential biological effect which could accelerate the soft tissue healing process and optimize the handling properties of the granules
The purpose of this clinical trial is to assess the capacity and the clinical feasibility of the dentin graft processed with injectable platelet rich fibrin I-PRF to an adherent tooth-derived conglomerate for socket preservation Moreover Platelet-rich fibrin incorporated with antibiotics showed long-term anti-bacterial effect against F nucleatum and S aureus
Both autogenous demineralized dentin graft combined with injectable PRF sticky demineralized tooth and autogenous demineralized dentin graft ADDG alone loaded with metronidazole or not with or without collagen membrane have been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear
Dentin contains several growth factors including transforming growth factor beta TGF-β insulin-like growth factor-II IGF-II and bone morphogenetic protein-2 BMP-2 which could be of pivotal importance during any healing event Demineralization of dentin has been further proposed to expose its collagen matrix liberate and fossilized growth factors and thereby enhance its regenerative capacity
It has been proven that autogenous demineralized dentin graft is effective at reducing dimensional losses of alveolar sockets after 6 months with no adverse effects
The efficacy of platelet rich fibrin PRF in promoting wound healing and tissue regeneration is at the center of a recent academic debate The liquid fibrinogen has been shown to bind particulate bone grafts which are then called sticky bon This binding improves the stabilization of the particles in the defect It adds a potential biological effect which could accelerate the soft tissue healing process and optimize the handling properties of the granules
The purpose of this clinical trial is to assess the capacity and the clinical feasibility of the dentin graft processed with injectable platelet rich fibrin I-PRF to an adherent tooth-derived conglomerate for socket preservation Moreover Platelet-rich fibrin incorporated with antibiotics showed long-term anti-bacterial effect against F nucleatum and S aureus
Both autogenous demineralized dentin graft combined with injectable PRF sticky demineralized tooth and autogenous demineralized dentin graft ADDG alone loaded with metronidazole or not with or without collagen membrane have been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None