Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP

Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06382974
• Other study ID #: 3-3-14
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: Yara Mahmoud
• Phone: 01100764737
• Email: yara.mahmoud[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Male and female patients

2. Patients 18 to 40 years old

3. Radicular cyst with a maximum diameter from 1.5 to 4.0 cm;

4. Focal teeth were preserved with root canal treatment;

5. No previous surgical treatment of the cyst site;

6. No evidence of acute inflammation;

7. In good physical status and oral health;

8. Regular attendance at control visits

Exclusion Criteria:

1. Patients < 17 years old

2. Radicular cyst with a maximum diameter < 1.5 cm.

3. Pregnancy or lactation

4. Aggregate systemic pathologies such as diabetes, thyroid disorders, and bone metabolism diseases, among others;

5. Patients taking calcium, bisphosphonates, glucocorticoids, or other drugs that can interfere with the metabolism of bone;

6. Patients with uncontrolled periodontal conditions, endodontic conditions, and other oral disorders;

7. Heavy smokers (10 cigarettes/day or more)

Related Conditions & MeSH terms

• Bone Loss
• Infection

Intervention

Procedure:
• Cyst enucleation and bone grafting
cyst enucleation followed by bone grafting the residual bone defects using Atorvastatin combined with ß-TCP.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Rate of shrinkage of the residual bone defect	the shrinkage of the residual bone defects after bone grafting, measured from the following formula: pre-operative cyst volume - 3/6 months post-operative defect volume/pre-operative cyst volume x 100%.; it will be measured radiographically using CBCT through manual segmentation	3 moths post-operatively and 6 months post-operatively
Secondary	Incidence of Inflammation at the grafted site	any signs of inflammation; edema, redness or discharge	1 week post-operatively, 3 months post-operatively and 6 months post-operatively

External Links

•   first in-vivo study to test the methodology adopted in this research
•   the clinical study methodology adopted in this research