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

Dental Implant Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06016218
• Other study ID #: 260981
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 5, 2021
• Est. completion date: February 5, 2023

Study information

• Verified date: August 2023
• Source: British University In Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 5, 2023
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Extending to Pulp
• Dental Implant Failed

Intervention

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

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