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

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ClinicalTrials.gov Identifier: NCT06016218
Recruitment Status : Completed
First Posted : August 29, 2023
Last Update Posted : September 6, 2023
Sponsor:
Information provided by (Responsible Party):
British University In Egypt

Study Description
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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.


Condition or disease Intervention/treatment Phase
Dental Caries Extending to Pulp Dental Implant Failed Drug: Simvastatin Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Local Application of Platelet-Rich Fibrin Scaffold Loaded With Simvastatin Versus Bone Powder on Peri-Implant Bone Changes
Actual Study Start Date : January 5, 2021
Actual Primary Completion Date : January 5, 2022
Actual Study Completion Date : February 5, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: PRF
PRF alone was added to extraction site prior to implant insertion
 Drug: Simvastatin
Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone
Active Comparator: SIM+ PRF
PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion
 Drug: Simvastatin
Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone
Active Comparator: BO+ PRF
PRF + Bone powder are inserted into the extraction site before implant insertion.
 Drug: Simvastatin
Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone


Outcome Measures
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Primary Outcome Measures :
  1. Changes in crestal peri-imlant Bone [ Time Frame: 12 months ]
    Radiographic evaluation of crestal bone changes around the studied implants


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06016218


Locations
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Egypt
The British University in Egypt
Cairo, Egypt
Sponsors and Collaborators
British University In Egypt
More Information
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Responsible Party: British University In Egypt
ClinicalTrials.gov Identifier: NCT06016218    
Other Study ID Numbers: 260981
First Posted: August 29, 2023    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Simvastatin
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors