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

NCT05008068 | Completed Phase 1 DMC

• 1 other identifier: 0012490
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet-rich Fibrin; Simvastatin

Keywords

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

Outcome Measures

Primary Outcomes (3)

• The measurement of bone thickness

  Measuring unit in millimeters , measuring device is CBCT software

  After 3 months of the osteotomy and application of Simvastatin

• The measurement of bone thickness

  Measuring unit in millimeters , measuring device is CBCT software

  After 6 months of the osteotomy and application of Simvastatin

• The measurement of bone thickness

  Measuring unit in millimeters , measuring device is CBCT software

  After 12 months of the osteotomy and application of Simvastatin

Study Arms (2)

PRF alone

EXPERIMENTAL

Drug: Simvastatin

PRF in addition to Simvastatin

ACTIVE COMPARATOR

Drug: Simvastatin

Interventions

Simvastatin DRUG

Simvastatin with PRF at site of osteotome

PRF alone; PRF in addition to Simvastatin

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients with a partially edentulous mandible indicated for rehabilitation with implant prostheses,
• any extractions, or surgeries performed at least six months earlier.

You may not qualify if:

• 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

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British University in EGYPT

Cairo, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 17, 2021
• Study Start: August 12, 2019
• Primary Completion: September 12, 2020
• Study Completion: September 12, 2020
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)