Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621719
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Evaluation of Secondary Alveolar Cleft Reconstruction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Secondary Alveolar Cleft Reconstruction Using Bone Matrix Prepared From Cancellous Particulates Mixed With Albumin-PRF or L-PRF A Randomized Controlled Clinical Trial
Status:
NOT_YET_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 rehabilitation of the disorganized maxilla is the primary objective of secondary alveolar bone grafting SABG for alveolar clefts as the bony reconstruction of the discontinued maxillary arch would permit proper anterior teeth eruption improve their orthodontic movements restore the nasal and alar base symmetry counteract the growth disturbance effects and seal the oronasal communication By the time the transverse growth of the maxillary arch is nearly complete during the mixed dentition stage SABG intends to bridge the maxillary continuity by a quantitative bone graft entity that minimizes the maxillary collapse and growth impairment after an appropriate separation and elevation of the nasal and mucosal flaps
Detailed Description:
By its ample content of subcutaneous autogenous cancellous bone particulates the iliac crest is considered the gold standard for SABG of alveolar clefts with optimal restoration of the maxillary continuity and fair subsequent teeth eruption orthodontic movements or implant placement However several studies have demonstrated that the final volume of the sole iliac crest particulate graft is unpredictable
Sohn et al in 2010 introduced the growth-factors enriched bone matrix sticky bone concept that incorporates the platelet-rich fibrin PRF into the particulate grafts to enhance their moldability and enrich them with three-dimensional 3D fibrin networking scaffold and high concentrations of growth factors which promote cell division modulate tissue healing and induce angiogenesis such as vascular endothelial growth factors VEGF recombinant human platelet-derived growth factor rhPDGF transforming growth factors ß-1 TGFß-1 bone morphogenic protein-2 rhBMP2 insulin growth factor-I IFG-I and epithelial growth factor EGF and interleukins
During the last decade various PRF preparations and centrifuge protocols have been developed forming various platelet products with different biological constitutions and potential applications The PRF evolution began with the development of the leukocyte- and platelet-rich fibrin L-PRF by an increased centrifuge time and speed followed by advanced platelet-rich fibrin A-PRF injectable platelet-rich fibrin I-PRF horizontal platelet-rich fibrin H-PRF Concentrated PRF C-PRF and most recently the albumin-PRF Albumin gel
The L-PRF employs the extract of the platelet-rich plasma PRP in the form of a fibrin clot meanwhile discarding the platelet-poor plasma PPP On the other hand the albumin gel preparation employs the aspiration and heating of the platelet-poor plasma PPP the upper layer then remixing it with the PRP layer and the buffy coat the lower layers after being allowed to cool Although the heating and cooling process would threaten the vitality of cells and the growth factor of the PPP layer this will polymerize its plasmatic proteins and denature the high albumin content as a result of the replacement of the weak hydrogen bond linkages within the protein molecule with densely organized ones in addition to the formation of thermal aggregate cross-linkage fibrin networks with an overall endured mechanical strength prolonged degradation time up to 4-6months and extended release of growth factors up to ten days
Sohn et al in 2010 introduced the growth-factors enriched bone matrix sticky bone concept that incorporates the platelet-rich fibrin PRF into the particulate grafts to enhance their moldability and enrich them with three-dimensional 3D fibrin networking scaffold and high concentrations of growth factors which promote cell division modulate tissue healing and induce angiogenesis such as vascular endothelial growth factors VEGF recombinant human platelet-derived growth factor rhPDGF transforming growth factors ß-1 TGFß-1 bone morphogenic protein-2 rhBMP2 insulin growth factor-I IFG-I and epithelial growth factor EGF and interleukins
During the last decade various PRF preparations and centrifuge protocols have been developed forming various platelet products with different biological constitutions and potential applications The PRF evolution began with the development of the leukocyte- and platelet-rich fibrin L-PRF by an increased centrifuge time and speed followed by advanced platelet-rich fibrin A-PRF injectable platelet-rich fibrin I-PRF horizontal platelet-rich fibrin H-PRF Concentrated PRF C-PRF and most recently the albumin-PRF Albumin gel
The L-PRF employs the extract of the platelet-rich plasma PRP in the form of a fibrin clot meanwhile discarding the platelet-poor plasma PPP On the other hand the albumin gel preparation employs the aspiration and heating of the platelet-poor plasma PPP the upper layer then remixing it with the PRP layer and the buffy coat the lower layers after being allowed to cool Although the heating and cooling process would threaten the vitality of cells and the growth factor of the PPP layer this will polymerize its plasmatic proteins and denature the high albumin content as a result of the replacement of the weak hydrogen bond linkages within the protein molecule with densely organized ones in addition to the formation of thermal aggregate cross-linkage fibrin networks with an overall endured mechanical strength prolonged degradation time up to 4-6months and extended release of growth factors up to ten days
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