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

• Sponsor: British University In Egypt (Other)
• Overall Status: Completed
• CT.gov ID: NCT05008068
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Platelet-rich Fibrin; Simvastatin	Drug: Simvastatin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Single (Participant)
• Primary Purpose: Screening
• Official Title: Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes
• Actual Study Start Date: Aug 12, 2019
• Actual Primary Completion Date: Sep 12, 2020
• Actual Study Completion Date: Sep 12, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The measurement of bone thickness [After 3 months of the osteotomy and application of Simvastatin]

   Measuring unit in millimeters , measuring device is CBCT software

2. The measurement of bone thickness [After 6 months of the osteotomy and application of Simvastatin]

   Measuring unit in millimeters , measuring device is CBCT software

3. The measurement of bone thickness [After 12 months of the osteotomy and application of Simvastatin]

   Measuring unit in millimeters , measuring device is CBCT software

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: All
• 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The British University in EGYPT	Cairo		Egypt

Sponsors and Collaborators

• British University In Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sara Fikry El Shafei, Principal investigator, British University In Egypt
• ClinicalTrials.gov Identifier: NCT05008068
• Other Study ID Numbers: 0012490
• First Posted: Aug 17, 2021
• Last Update Posted: Aug 17, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sara Fikry El Shafei, Principal investigator, British University In Egypt: Platelet-rich fibrin; Simvastatin; Bone loss; Peri-implant Bone Changes
• Additional relevant MeSH terms: Simvastatin

Study Results

No Results Posted as of Aug 17, 2021