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

British University In Egypt

Status and phase

Completed

Phase 1

Conditions

Platelet-rich Fibrin

Simvastatin

Treatments

Drug: Simvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT05008068

0012490

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Ages

45 to 60 years old

Volunteers

Accepts Healthy Volunteers

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