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

Phase 1

Completed

• Conditions: Platelet-rich Fibrin; Simvastatin
• Interventions: Drug: Simvastatin

• Registration Number: NCT05008068
• Lead Sponsor: British University In Egypt

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-12
• Primary Completion: 2020-09-12
• Study Completion: 2020-09-12
• Status Verified: 2021-08
• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-08-09
• Last Update Submitted: 2021-08-09
• Study First Posted: 2021-08-17
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

• patients with a partially edentulous mandible indicated for rehabilitation with implant prostheses,
• any extractions, or surgeries performed at least six months earlier.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRF alone	Simvastatin	-
PRF in addition to Simvastatin	Simvastatin	-

Primary Outcome Measures

Name	Time	Method
The measurement of bone thickness	After 12 months of the osteotomy and application of Simvastatin	Measuring unit in millimeters , measuring device is CBCT software

Trial Locations

Locations (1)

The British University in EGYPT; 🇪🇬 Cairo, Egypt