search
Back to results

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

Primary Purpose

Dental Caries Extending to Pulp, Dental Implant Failed

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
British University In Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries Extending to Pulp

Eligibility Criteria

45 Years - 60 Years (Adult)MaleAccepts 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.

Sites / Locations

  • The British University in Egypt

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

PRF

SIM+ PRF

BO+ PRF

Arm Description

PRF alone was added to extraction site prior to implant insertion

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 12, 2023
Last Updated
September 1, 2023
Sponsor
British University In Egypt
search

1. Study Identification

Unique Protocol Identification Number
NCT06016218
Brief Title
Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes
Official Title
Effect of Local Application of Platelet-Rich Fibrin Scaffold Loaded With Simvastatin Versus Bone Powder on Peri-Implant Bone Changes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
January 5, 2022 (Actual)
Study Completion Date
February 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British University In Egypt

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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: Measuring bone changes around the implant by cone beam 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries Extending to Pulp, Dental Implant Failed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRF
Arm Type
Placebo Comparator
Arm Description
PRF alone was added to extraction site prior to implant insertion
Arm Title
SIM+ PRF
Arm Type
Active Comparator
Arm Description
PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion
Arm Title
BO+ PRF
Arm Type
Active Comparator
Arm Description
PRF + Bone powder are inserted into the extraction site before implant insertion.
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone
Primary Outcome Measure Information:
Title
Changes in crestal peri-imlant Bone
Description
Radiographic evaluation of crestal bone changes around the studied implants
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
The British University in Egypt
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs