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

August 9, 2021 updated by: Sara Fikry El Shafei, British University In Egypt

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • The British university in Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRF alone
Drug: Simvastatin
Simvastatin with PRF at site of osteotome
Active Comparator: PRF in addition to Simvastatin
Drug: Simvastatin
Simvastatin with PRF at site of osteotome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 3 months of the osteotomy and application of Simvastatin
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
After 6 months of the osteotomy and application of Simvastatin
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
After 12 months of the osteotomy and application of Simvastatin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British University In Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2019

Primary Completion (Actual)

September 12, 2020

Study Completion (Actual)

September 12, 2020

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0012490

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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