Simvastatin Around Immediate Implant

March 16, 2021 updated by: Mina Adel Rizk Botros, Ain Shams University

Restoration of Immediate Peri-implant Defect by Simvastatin: a Controlled Clinical and Cone Beam Computed Tomography Study

The study evaluated the effect of local application of simvastatin around immediate implant on the amount of gap fill, ridge dimensional alterations and bone density in humans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between 20 and 50 years old
  • requiring the extraction of 2 non-restorable maxillary canine or premolar on each side of the arch
  • following extraction, the crestal bone had to be located 3 mm apical to the free gingival margin
  • at least 3 mm of bone beyond the root apex was required to guarantee implant primary stability

Exclusion Criteria:

  • unstable systemic diseases precluding surgical procedures
  • compromised general health conditions that would impair bone healing including present history of bone irradiation, patient on bisphosphonates therapy, antitumor chemotherapy
  • pregnancy
  • compromised healing conditions e.g. uncontrolled diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Simvastatin group
simvastatin gel (1.2 mg/0.1 ml of solid lipid nanoparticles) was locally applied to fill the jumping distance.
Drug: Simvastatin
single injection of simvastatin gel in the gap around immediately placed implant
Placebo Comparator: Control group
the solid lipid nanoparticles carrier was injected into the jumping distance.
Drug: Placebo
single injection of the solid lipid nanoparticle carrier in the gap around immediately placed implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of simvastatin on gap fill
Time Frame: 3 months after implant placement
using cone beam computed tomography
3 months after implant placement
Effect of simvastatin on horizontal ridge dimension
Time Frame: 3 months after implant placement
using cone beam computed tomography
3 months after implant placement
Effect of simvastatin on crestal bone level
Time Frame: 3 months after implant placement
using cone beam computed tomography
3 months after implant placement
Effect of simvastatin on bone density
Time Frame: 3 months after implant placement
using cone beam computed tomography
3 months after implant placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of wound healing
Time Frame: 1 week after implant placement
wound healing index
1 week after implant placement
Quality of wound healing
Time Frame: 2 weeks after implant placement
wound healing index
2 weeks after implant placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2015

Primary Completion (Actual)

February 15, 2016

Study Completion (Actual)

May 3, 2016

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PER 15-1M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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