Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes

Study Overview
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Brief Summary
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ACKGROUND: Simvastatin (SIM), a pharmacological drug used for hypercholesterolemia, has been found to have pleotropic effects on bones. Simvastatin together with the appropriate carrier may decrease bone loss around implants. PURPOSE: To compare the long term effects of autologous PRF alone, and PRF loaded with SIM on peri-implant bone changes and implant stability in patients undergoing implant rehabilitation. MATERIALS AND METHODS: A randomized controlled split-mouth studyincluding 8 males between the ages of 45-60 years. Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy. A cone-beam CT was used to evaluate bone changes around the insertion of implant sites atthree, six, and twelve months postoperatively. The secondary outcome included measuring implant stability using Ostell device at baseline and 3 months post insertion. To compare groups at different time periods, data was examined using a two-way (ANOVA) analysis.

Official Title
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Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes

Conditions
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Platelet-rich Fibrin, Simvastatin

Intervention / Treatment
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* Drug: Simvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a partially edentulous mandible indicated for rehabilitation with implant prostheses, any extractions, or surgeries performed at least six 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 such as psychologically unstable patients

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


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: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRF alone<br> | Drug: Simvastatin<br>* Simvastatin with PRF at site of osteotome<br>|
| Active Comparator: PRF in addition to Simvastatin<br> | Drug: Simvastatin<br>* Simvastatin with PRF at site of osteotome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measurement of bone thickness | Measuring unit in millimeters , measuring device is CBCT software | After 3 months of the osteotomy and application of Simvastatin | 
| The measurement of bone thickness | Measuring unit in millimeters , measuring device is CBCT software | After 6 months of the osteotomy and application of Simvastatin | 
| The measurement of bone thickness | Measuring unit in millimeters , measuring device is CBCT software | After 12 months of the osteotomy and application of Simvastatin | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet-rich fibrin, Simvastatin, Bone loss, Peri-implant Bone Changes