NCT06016218

Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes

Effect of Local Application of Platelet-Rich Fibrin Scaffold Loaded With Simvastatin Versus Bone Powder on Peri-Implant Bone Changes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: British University In Egypt · Academic / Other
• Sex: Male
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not. This will be done through: 1. Measuring bone changes around the implant by cone beam 2. Measuring change in bone density around the implants B- Evaluate the effect of statins on osteoblasts activity and expression of various osteogenic products in vitro.

Detailed description

Twenty four patients requiring rehabilitation by immediate implantation in an extraction socket were recruited for this study. The Patients were divided into three groups (n=8), For the first group; immediately after extraction, PRF alone was added into the extraction socket prior to implant insertion. For the second group, PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion. For the third Group; PRF + Bone powder are inserted into the extraction site before implant insertion. A conebeam CT was used to evaluate the effect on bone changes and bone density around implant sites, for every patient in all implant groups immediately after the surgery and at follow-up time. In vitro experiment: isolation of human Adipose mesenchymal stem cells (hAd-MSCs), characterization and osteogenic differentiation will be done. The cells were divided into two groups one control group and the other statin group. Osteogenic markers were measured in both groups and statistical analysis performed

Conditions

• Dental Caries Extending to Pulp
• Dental Implant Failed

Interventions

Type	Name	Description
DRUG	Simvastatin	Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone

Timeline

• Start date: 2021-01-05
• Primary completion: 2022-01-05
• Completion: 2023-02-05
• First posted: 2023-08-29
• Last updated: 2023-09-06

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study