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

Platelet-rich Fibrin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05008068
• Other study ID #: 0012490
• Status: Completed
• Phase: Phase 1
• Start date: August 12, 2019
• Est. completion date: September 12, 2020

Study information

• Verified date: August 2021
• Source: British University In Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 12, 2020
• Est. primary completion date: September 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Platelet-rich Fibrin

Intervention

Drug:
• Simvastatin
Simvastatin with PRF at site of osteotome

Locations

Country	Name	City	State
Egypt	The British University in EGYPT	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
British University In Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measurement of bone thickness	Measuring unit in millimeters , measuring device is CBCT software	After 3 months of the osteotomy and application of Simvastatin
Primary	The measurement of bone thickness	Measuring unit in millimeters , measuring device is CBCT software	After 6 months of the osteotomy and application of Simvastatin
Primary	The measurement of bone thickness	Measuring unit in millimeters , measuring device is CBCT software	After 12 months of the osteotomy and application of Simvastatin