Skip to content

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

Effect of Local Application of Platelet-Rich Fibrin Scaffold Loaded With Simvastatin Versus Bone Powder on Peri-Implant Bone Changes

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06016218
Enrollment
24
Registered
2023-08-29
Start date
2021-01-05
Completion date
2023-02-05
Last updated
2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries Extending to Pulp, Dental Implant Failed

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

Interventions

DRUGSimvastatin

Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone

Sponsors

British University In Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
45 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in crestal peri-imlant Bone12 monthsRadiographic evaluation of crestal bone changes around the studied implants

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026