Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cyst enucleation and bone grafting.
- Who it may be relevant to
- Registry conditions: Infection, Bone Loss. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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 (1.5 - 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 0.1 mg: 14 mg, which was the methodology adopted by Gouda et al, based on the methodology of Nyan et al.
Interventions
- Procedure Cyst enucleation and bone grafting
cyst enucleation followed by bone grafting the residual bone defects using Atorvastatin combined with β-TCP.
Primary outcome measures
- The Rate of shrinkage of the residual bone defect [Time frame: 3 moths post-operatively and 6 months post-operatively]
Secondary outcome measures (1)
- Incidence of Inflammation at the grafted site [Time frame: 1 week post-operatively, 3 months post-operatively and 6 months post-operatively]
Eligibility criteria
Inclusion criteria
- Male and female patients
- Patients 18 to 40 years old
- Radicular cyst with a maximum diameter from 1.5 to 4.0 cm;
- Focal teeth were preserved with root canal treatment;
- No previous surgical treatment of the cyst site;
- No evidence of acute inflammation;
- In good physical status and oral health;
- Regular attendance at control visits
Exclusion criteria
- Patients < 17 years old
- Radicular cyst with a maximum diameter < 1.5 cm.
- Pregnancy or lactation
- Aggregate systemic pathologies such as diabetes, thyroid disorders, and bone metabolism diseases, among others;
- Patients taking calcium, bisphosphonates, glucocorticoids, or other drugs that can interfere with the metabolism of bone;
- Patients with uncontrolled periodontal conditions, endodontic conditions, and other oral disorders;
- Heavy smokers (10 cigarettes/day or more)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT06382974 · 3-3-14