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CompletedNCT05008068Updated Aug 17, 2021

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

A Phase 1 interventional study of Simvastatin in Platelet-rich Fibrin and Simvastatin, sponsored by British University In Egypt. Completed at 1 site in Egypt. Open to participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-17.

Sponsored by British University In Egypt · Phase 1, Interventional, and Screening

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Aug 2019, registered Aug 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Non-randomized
Ages
45 Years to 60 Years
01

Study 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.

02

Conditions studied

  • Platelet-rich Fibrin
  • Simvastatin

Keywords

  • Platelet-rich fibrin
  • Simvastatin
  • Bone loss
  • Peri-implant Bone Changes
03

In context

Lead sponsor

British University In Egypt is the lead sponsor of 67 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 60 Years
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    PRF alone

    Drug: Simvastatin

  • Active comparator
    PRF in addition to Simvastatin

    Drug: Simvastatin

Interventions

  • DrugSimvastatin

    Simvastatin with PRF at site of osteotome

06

What researchers measure

Primary outcomes

  1. The measurement of bone thickness

    Measuring unit in millimeters , measuring device is CBCT software

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

  2. The measurement of bone thickness

    Measuring unit in millimeters , measuring device is CBCT software

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

  3. The measurement of bone thickness

    Measuring unit in millimeters , measuring device is CBCT software

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

07

Study locations

1 site
  • The British University in EGYPT
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05008068
Lead sponsor
British University In Egypt
Responsible party
Sara Fikry El Shafei (Principal investigator, British University In Egypt) — Principal investigator
First posted
Aug 17, 2021
Start date
Aug 12, 2019
Primary completion
Sep 12, 2020
Completion
Sep 12, 2020
Last update
Aug 17, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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