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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05008068

Enrollment

Registered

2021-08-17

Start date

2019-08-12

Completion date

2020-09-12

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platelet-rich Fibrin, Simvastatin

Keywords

Platelet-rich fibrin, Simvastatin, Bone loss, Peri-implant Bone Changes

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.

Interventions

DRUGSimvastatin

Simvastatin with PRF at site of osteotome

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Subject)

Intervention 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.

Eligibility

Age

45 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The measurement of bone thickness	After 3 months of the osteotomy and application of Simvastatin	Measuring unit in millimeters , measuring device is CBCT software

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026