Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382974
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-04-22
Brief Title:
Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP in the Treatment of Bone Defects After Radicular Jaw Cyst Enucleation Using CBCT-based Volumetric Analysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This case series study aims to evaluate the local effects of Atorvastatin which belongs to the family of lipid-lowering drugs known as statins combined with β-TCP which is a synthetic osteoconductive bone graft on the volume of the residual bone defects and on hastening the bone regeneration after radicular jaw cyst enucleation using CBCT-based volumetric analysis to calculate the shrinkage rate of these defects
Detailed Description:
Statement of the problem
According to the literature the residual bone defects after medium-large-sized jaw cyst enucleation pose the risk for infection insufficient healing and pathological fracture the gold standard of bone grafting materials remains the autologous bone graft yet it is accompanied by risks including second surgery the morbidity of the donor site excessive bleeding etc
Therefore there is a constant search for alternative bone grafting materials this is where the addition of atorvastatin to an osteoconductive synthetic bone grafting material β-TCP comes in β-TCP takes anywhere from 6 to 18 months for complete resorption and replacement by bone according to the literature
The addition of an osteoinductive material to an osteoconductive grafting material like β-TCP holds two premises increasing the resorption of the β-TCP particles at the expense of bone deposition and therefore leads to hastening the bone generation of the residual bone defects
Rationale
Studies have shown that the local application of lipid-lowering drugs statins induces bone growth by stimulating BMP-2 therefore the addition of these pharmacological agents to osteoconductive bone graft materials which lack osteogenic properties could be a promising approach for bone regeneration
However there is still no consensus in the literature on the optimal therapeutic dose and mode of application for statins Furthermore limited studies are available in the literature regarding the use of statins especially Atorvastatin as a biological modifier in filling bone defects after cyst enucleation
Therefore the purpose of this study is to validate and evaluate the osteoinductivity of statins β-TCP combination using the Gouda et al methodology used in maxillary sinus lifting using simvastatin but instead using atorvastatin in filling the residual defects of medium-large odontogenic radicular cysts 15 - 4 cm which shows the suppressive influence on bone formation as well as a greater risk for pathological fracture infection and insufficient bone healing
Methodology
The ratio of atorvastatin to β-TCP will be 01 mg 14 mg which was the methodology adopted by Gouda et al based on the methodology of Nyan et al
According to the literature the residual bone defects after medium-large-sized jaw cyst enucleation pose the risk for infection insufficient healing and pathological fracture the gold standard of bone grafting materials remains the autologous bone graft yet it is accompanied by risks including second surgery the morbidity of the donor site excessive bleeding etc
Therefore there is a constant search for alternative bone grafting materials this is where the addition of atorvastatin to an osteoconductive synthetic bone grafting material β-TCP comes in β-TCP takes anywhere from 6 to 18 months for complete resorption and replacement by bone according to the literature
The addition of an osteoinductive material to an osteoconductive grafting material like β-TCP holds two premises increasing the resorption of the β-TCP particles at the expense of bone deposition and therefore leads to hastening the bone generation of the residual bone defects
Rationale
Studies have shown that the local application of lipid-lowering drugs statins induces bone growth by stimulating BMP-2 therefore the addition of these pharmacological agents to osteoconductive bone graft materials which lack osteogenic properties could be a promising approach for bone regeneration
However there is still no consensus in the literature on the optimal therapeutic dose and mode of application for statins Furthermore limited studies are available in the literature regarding the use of statins especially Atorvastatin as a biological modifier in filling bone defects after cyst enucleation
Therefore the purpose of this study is to validate and evaluate the osteoinductivity of statins β-TCP combination using the Gouda et al methodology used in maxillary sinus lifting using simvastatin but instead using atorvastatin in filling the residual defects of medium-large odontogenic radicular cysts 15 - 4 cm which shows the suppressive influence on bone formation as well as a greater risk for pathological fracture infection and insufficient bone healing
Methodology
The ratio of atorvastatin to β-TCP will be 01 mg 14 mg which was the methodology adopted by Gouda et al based on the methodology of Nyan et al
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