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

Study Overview
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Brief Summary
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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: Measuring bone changes around the implant by cone beam 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
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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

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

Conditions
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Dental Caries Extending to Pulp, Dental Implant Failed

Intervention / Treatment
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* Drug: Simvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Badly Broken Down Tooth requiring extraction Medically Free Any other procedures or surgeries were performed 6 months earlier Exclusion Criteria: patients with systemic diseases affecting bone quality or resorption temporomandibular joint dysfunction severe attrition or parafunctional habits patients undergoing radiotherapy or chemotherapy heavy smokers vulnerable groups like psychologically unstable patients.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PRF<br>PRF alone was added to extraction site prior to implant insertion | Drug: Simvastatin<br>* Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone<br>|
| Active Comparator: SIM+ PRF<br>PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion | Drug: Simvastatin<br>* Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone<br>|
| Active Comparator: BO+ PRF<br>PRF + Bone powder are inserted into the extraction site before implant insertion. | Drug: Simvastatin<br>* Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in crestal peri-imlant Bone | Radiographic evaluation of crestal bone changes around the studied implants | 12 months |