Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes

Phase 1

Completed

• Conditions: Dental Caries Extending to Pulp; Dental Implant Failed
• Interventions: Drug: Simvastatin

• Registration Number: NCT06016218
• Lead Sponsor: British University In Egypt

Brief Summary

This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not.

This will be done through:

1. Measuring bone changes around the implant by cone beam

2. Measuring change in bone density around the implants

B- Evaluate the effect of statins on osteoblasts activity and expression of various osteogenic products in vitro.

Detailed Description

Twenty four patients requiring rehabilitation by immediate implantation in an extraction socket were recruited for this study. The Patients were divided into three groups (n=8), For the first group; immediately after extraction, PRF alone was added into the extraction socket prior to implant insertion. For the second group, PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion. For the third Group; PRF + Bone powder are inserted into the extraction site before implant insertion. A conebeam CT was used to evaluate the effect on bone changes and bone density around implant sites, for every patient in all implant groups immediately after the surgery and at follow-up time. In vitro experiment: isolation of human Adipose mesenchymal stem cells (hAd-MSCs), characterization and osteogenic differentiation will be done. The cells were divided into two groups one control group and the other statin group. Osteogenic markers were measured in both groups and statistical analysis performed

Study Timeline

• Study Start: 2021-01-05
• Primary Completion: 2022-01-05
• Study Completion: 2023-02-05
• Study First Submitted: 2023-06-12
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-29
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Badly Broken Down Tooth requiring extraction
• Medically Free
• Any other procedures or surgeries were performed 6 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 like psychologically unstable patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SIM+ PRF	Simvastatin	PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion
BO+ PRF	Simvastatin	PRF + Bone powder are inserted into the extraction site before implant insertion.
PRF	Simvastatin	PRF alone was added to extraction site prior to implant insertion

Primary Outcome Measures

Name	Time	Method
Changes in crestal peri-imlant Bone	12 months	Radiographic evaluation of crestal bone changes around the studied implants

Trial Locations

Locations (1)

The British University in Egypt; 🇪🇬 Cairo, Egypt