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OpenTrials
Completed

NCT Number: NCT06016218

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

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.

Completed

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Key information

Conditions

Dental Caries Extending to Pulp Dental Implant Failed

Age range

45 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The British University in Egypt

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

simvastatin

Drug

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

Primary outcomes

  1. Changes in crestal peri-imlant Bone

    Time frame: 12 months

    Radiographic evaluation of crestal bone changes around the studied implants

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 29, 2023
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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