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

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.

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Key information

Conditions

Platelet-rich Fibrin Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Simvastatin

Age range

45 year–60 year

Study type

Interventional

Phase

Phase 1

Primary location

The British University in EGYPT

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

Simvastatin with PRF at site of osteotome

Primary outcomes

The measurement of bone thickness

Time frame: After 3 months of the osteotomy and application of Simvastatin

Measuring unit in millimeters , measuring device is CBCT software
The measurement of bone thickness

Time frame: After 6 months of the osteotomy and application of Simvastatin

Measuring unit in millimeters , measuring device is CBCT software
The measurement of bone thickness

Time frame: After 12 months of the osteotomy and application of Simvastatin

Measuring unit in millimeters , measuring device is CBCT software

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Aug 17, 2021
Registry last updated: Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed