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

British University In Egypt

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dental Implant Failed; Dental Caries Extending to Pulp

Treatments: Drug: Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT06016218

260981

Details and patient eligibility

About

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.

Full 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

Enrollment: 24 patients

Sex: Male

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

PRF

Placebo Comparator group

Description:

PRF alone was added to extraction site prior to implant insertion

Treatment:

Drug: Simvastatin

SIM+ PRF

Active Comparator group

Description:

PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion

Treatment:

Drug: Simvastatin

BO+ PRF

Active Comparator group

Description:

PRF + Bone powder are inserted into the extraction site before implant insertion.

Treatment:

Drug: Simvastatin